18 research outputs found
Vaginal prolapse surgery : an epidemiological perspective : studies of native tissue repair versus implants, surgeonsÂŽ practical experiences and five year follow-up in the swedish national quality register for gynecological surgery
No full textBackground: Pelvic organ prolapse (POP) is a common condition that impacts on quality of life for many women. The mean age of Swedish women operated for POP is 60 years, and with a life expectancy of approximately 84 years this means that the average patient will live 24 years subsequent to the operation. Therefore, sustainable long-term results of POP surgery are essential. In an effort to improve long-term outcomes of vaginal prolapse surgery, mesh materials have been developed for this purpose. In Sweden, synthetic mesh is used in 7.4% of all primary operations without any coherent consensus about their use. Prolapse surgery is regarded as a routine procedure performed at almost every hospital in Sweden, but a large proportion of the surgeons are inexperienced. In actuality, 73% of them perform the procedure once a month or less frequently. Simultaneously, surgery for POP has been reported to have a highfailure rate internationally. For most surgeons, the operation is a low-frequency procedure, and outcomes have been reported as unsatisfactory. The specific aims of these thesis were to examine:- Mesh-augmented repairs impact on operative results compared to nativetissue repair.- Surgical experience in performing a specific operation and utilize this knowledge in analysing how it may (or may not) affect operative results.- Long-term (5 year) national follow up of POP operations, regarding both the objective epidemiological data and the patient-reported outcomes. Methods: The studies in this thesis are based on data from the Swedish National Quality Register for Gynaecological Surgery (GynOp), which covers approximately 90% of all gynaecological operations in Sweden. The comparative follow-up of POP surgery using non-absorbable polypropylene mesh versus colporrhaphy using native tissue was analysed in two different cohorts, of women with a primary cystocele and women with a relapse after surgery for a rectocele. Both surgeon reported results and patient-reported outcomes (PROMs) were analysed 1 year post-surgery. Information about surgeonsâ experience in performing POP operations was extracted from GynOp over 9 years. Inclusion criteria were otherwise healthy patients who underwent anterior or posterior native tissue repair, or both. The operations were divided into four groups according to the operative experience of the surgeon (measured as average number of operations per active year). Both PROM results and surgeon-reported outcomes after 1 year were investigated. For the long-term follow-up 5 years after any operation for a vaginal prolapse, a new questionnaire to capture PROM data was designed, validated and nationally distributed. Information about re-operations was extracted directly from GynOp. Results: Mesh-augmented repair of a primary cystocele had a significantly better outcome in terms of absence of symptoms, compared with native tissue repair, OR 1.53(95% CI 1.10-2.13), but also had more complications directly related to the procedure (OR 1.51, RD=6.6%). For recurrent rectocele, mesh was superior to native tissue repair, OR 2.06 (95% CI 1.03-4.35); the number of postoperative complications was equal in the two groups. Among the 1,092 surgeons who were active POP surgeons during the study, 803(73%) participated in POP operations once a month or less frequently in their active years. No differences in patient or surgeon-reported outcomes were seen between the âexperience groupsâ. Kaplan-Meier curves for re-operation after a primary POP operation showed an overall retreatment rate of 11.2% after 5 years. The response rate for the patient questionnaire was 74.9%. Overall, 70% of the patients reported no symptoms, and around 72% and 82% were satisfied with the operative results and felt that their symptoms had improved, respectively. Discussion: Mesh use was, after 1 year of follow-up, generally characterized by a high cure rate and varying degrees of complications, such as postoperative pain. However, for recurrent rectocele, we found no immediate drawbacks of the method compared with native tissue repair, with the same high cure rate as seen in other compartments. Surgeon experience had no impact on the native tissue operation, and any inconsistency of outcome is more likely inherent in the method than attributable to a surgeonâs lack of experience.The 5-year results indicate that native tissue repair produces much better results, judging from overall Swedish results, than previously thought. This is backed up both by objective data indicating a minimal number of re-operations within 5 years for the most common cases (i.e. primary rectocele and cystocele) and by the outcomes reported by the patients themselves. Conclusions: Mesh-augmented repair is more effective than native tissue repair forrecurrent rectocele, and without increased risk of complications. Drawbacks of mesh repair vary for other compartments, and for primary operations.- Surgeonsâ operative experience in routine POP operations using native tissue has no impact on outcome after 1 year.- Long-term results of POP repair with native tissue are excellent, with a low risk of re-operation and a persistent absence of subjective symptoms.Bakgrund: Prolaps av bĂ€ckenbottens organ, vaginalprolaps (POP) Ă€r en vanlig Ă„komma ochpĂ„verkar livskvaliteten negativt för mĂ„nga kvinnor. GenomsnittsĂ„ldern för kvinnor som blir opererade för POP Ă€r 60 Ă„r och med en medellivslĂ€ngd pĂ„ cirka 84 Ă„r, betyder detta att den genomsnittliga patienten skall leva 24 Ă„r med operationsresultatet. HĂ„llbara resultat av kirugi över lĂ„ng tid Ă€r dĂ€rför helt essentiell. I ett försök att förbĂ€ttra lĂ„ngtidsresultaten av vaginalprolapsoperationer, blev nĂ€tmaterial (mesh) introducerat. I Sverige blir 7,4 % av alla primĂ€roperationer (första operationen) gjorda med syntetiskt nĂ€tmaterial, utan nĂ„gon samlad konsensus av hur och nĂ€r nĂ€ten skall anvĂ€ndas. I Sverige anses POP-kirurgi vara rutinoperationer, som utförs pĂ„ nĂ€stan alla sjukhus med en stor andel av operatörer med liten eller ingen rutin av operationen. Sammantaget blir 73 % av operationerna som utförs, gjorda avopertörer som i genomsnitt opererar POP en gĂ„ng i mĂ„naden eller mindre. De flesta kirurger opererar alltsĂ„ med lĂ„g frekvens och resultaten anses vara otillfredsstĂ€llande. I ett globalt perspektiv, har rapporterats att operation för vaginalprolaps ofta misslyckas. MĂ„len med avhandlingen var att undersöka:- Inflytande pĂ„ det operativa resultatet nĂ€r nĂ€t anvĂ€nds jĂ€mfört medoperationer utan nĂ€t.- Hur operatörens erfarenhet pĂ„verkar operationsresultat.- En nationell lĂ„ngtidsuppföljning (5 Ă„r) av prolapsoperationer, avseende bĂ„de objektiva epidemiologiska data och patientrapporterade utfall. Metod: Studierna i denna avhandling Ă€r alla baserade pĂ„ data frĂ„n Nationella kvalitetsregistret inom gynekologisk kirurgi (GynOp) som tĂ€cker drygt 90 % av alla gynekologiska operationer utförda i Sverige. De komparativa analyserna av uppföljning av prolapskirurgi efter antingen operation med icke-resorberbar polypropylenmesh (nĂ€t) eller operation utan nĂ€t, blev analyserade i tvĂ„ olika kohorter: Kvinnor med primĂ€r cystocele (framfall urinblĂ„san) och kvinnor med Ă„terfall av rektocele (framfall Ă€ndtarmen). BĂ„de lĂ€karrapporterade resultat och patientrapporterade utfall (PROM) blev analyserade efter 1 Ă„r. Information avseende kirurgens operativa erfarenhet av prolapsoperationer extraherades frĂ„n GynOp databasen under en tidsperiod pĂ„ 9 Ă„r. Avseende patienter var inklusionskriterier att de skulle vara i övrigt friska och genomgĂ„tt antingen frĂ€mre eller bakre plastik, eller en kombination av enbart de tvĂ„. Operationerna blev uppdelade i 4 grupper, efter operatörernas praktiska erfarenhet (genomsnittligt antal operationer per aktivt Ă„r som operatör). BĂ„de PROM och lĂ€karrapporterade resultat efter 1 Ă„r blev analyserade. För att undersöka lĂ„ngtidsresultaten efter operation för vaginalprolaps skapades en ny enkĂ€t, som efter validering distribuerades nationellt till patienter 5 Ă„r efter operationen. Information om reoperationsfrekvenser extraherades direkt frĂ„nGynOp. Resultat: NĂ€toperationer vid primĂ€r cystocele hade signifikant bĂ€ttre resultat ett Ă„r efter operation avseende patientrapporterad frĂ„nvaro av prolapssymptom Ă€n operation utan nĂ€t OR 1.53 (95% CI 1.10-2.13) men det rapporterades ocksĂ„ fler komplikationer relaterade till operationen nĂ€r nĂ€t anvĂ€ndes (OR 1.51, RD=6.6%). För recidiverande rectocele var nĂ€toperation överlĂ€gsen operationer utan nĂ€t OR 2.06 (95% CI 1.03-4.35) MĂ€ngden av postoperativa komplikationer var hĂ€r den samma i bĂ„da operationsgrupperna. Av de 1092 operatörer som var registrerade som aktiva POP operatörer i studien,var 803 (73 %) aktiva i POP operationer enbart 1 gĂ„ng per mĂ„nad eller mindre de Ă„r de var aktiva. Det var ingen mĂ€tbar skillnad mellan âerfarenhetsgrupperâavseende patientrapporterade eller lĂ€karraporterade parametrar. Kaplan Meier kurvor (hĂ„llbarhetskurvor) för reoperationer efter en primĂ€r POP operaton utan nĂ€t, visade en Ă„terbehandlingsfrekvens pĂ„ 11,2 % efter 5 Ă„r. Svarsfrekvensen pĂ„ enkĂ€ten var 74,9 %. Av de som ej behandlats igen med operation hade 70 % av patienterna inga symptom, och respektive 72 % var nöjda med operationsresultaten och 82 % kĂ€nde att deras symptom hade minskat. Diskussion: AnvĂ€ndning av nĂ€t, med 1 Ă„rs uppföljning, jĂ€mfört med utan nĂ€t, karakteriserades av en högre botandegrad, men med fler komplikationer, bland annat postoperativ smĂ€rta. Detta undantaget recidiverande rectocele dĂ€r inga skillnader i komplikationer jĂ€mfört med operationer utan nĂ€t hittades och med samma höga botandegradsom övriga nĂ€toperationer.viiiOperatörens erfarenhet hade inget inflytande pĂ„ operationens resultat, och en eventuellt lĂ„g botandegrad tycks vara mer sannolikt beroende pĂ„ metoden, Ă€n pĂ„ operatörens brist pĂ„ erfarenhet. 5 Ă„rs resultaten indikerar att operationer utan nĂ€t har mycket bĂ€ttre resultat Ă€n hittills kĂ€nt, baserat pĂ„ de övergripande svenska resultaten. Detta stöds av bĂ„de objektiva epidemiologiska data, som indikerar en minimal mĂ€ngd reoperationer inom 5 Ă„r för de vanligaste fallen (sĂ„som primĂ€ra cysto- och rectocele), och av patientens egna svar pĂ„ enkĂ€ten. Konklusioner- NĂ€toperationer Ă€r mer effektiva i att bota recidiverande retocele, och har inga mĂ€tbara nackdelar avseende komplikationer.- Operatörens manuella erfarenhet med operationer utan nĂ€t hade inget inflytande pĂ„ 1 Ă„rs resultaten.- LĂ„ngtidsresultaten efter operation utan nĂ€t Ă€r bra, med lĂ„g risk för reoperation och bestĂ„ende frĂ„nvaro av prolapssymptom efter 5 Ă„r.Baggrund: Prolaps af bĂŠkkenbundens organer (POP) er en almindelig lidelse, der stĂŠrkt pĂ„virker livskvaliteten for mange kvinder. Den gennemsnitlige svenske kvinde opereret for POP er 60 Ă„r ved operationen, og med en forventet gennemsnitlig levealder pĂ„ 84 Ă„r betyder dette, at patienten sandsynligvis vil leve omkring 24 Ă„r med operationsresultaterne. Netop derfor er pĂ„lidelige, holdbare langtidsresultater af operationen essentielle.I et forsĂžg pĂ„ at forbedre isĂŠr langtidsresultater af POP kirurgi, er net (mesh) materialer blevet introduceret. I Sverige bliver 7,4 % af alle primĂŠre operationer opereret med kirurgisk mesh uden nogen Ăžjensynlig konsensus eller ensartethed hvad angĂ„r deres optimale brug.I Sverige bliver POP kirurgi ligeledes anset som rutineoperationer udfĂžrt pĂ„ stort set ethvert hospital med en stor proportion af uerfarne operatĂžrer. I realiteten opererer 73 % af samtlige operatĂžrer, der har noget at gĂžre med POP operationer, mindre end 1 POP-operation om mĂ„neden i gennemsnit. POP er i litteraturen desuden rapporteret at vĂŠre behĂŠftet med en hĂžj rate af mislykkede operationer. Det vil sige, at for de fleste kirurger bliver denne procedure udfĂžrt med meget lav frekvens, og samtidigt er resultaterne Ăžjensynligt utilfredsstillende. MĂ„lene med denne doktorafhandling var at undersĂžge:- Operationsresultater med mesh sammenlignet med operation uden mesh.- LĂŠgens manuelle erfaring med native POP operationer, og hvordan (eller hvordan ikke) den har indflydelse pĂ„ resultaterne.- Langtidsresultaterne (5 Ă„r) pĂ„ national basis for POP operationer, bĂ„de iforhold til de objektive epidemiologiske data og de patientrapporterede udfald. Metoder: BĂ„de de lĂŠgerapporterede og de patientrapporterede resultater (PROM) blev analyseret 1 Ă„r efter operationen. Information angĂ„ende lĂŠgens erfaring med POP blev taget direkte fra GynOp databasen, og er opsamlet over en periode pĂ„ 9 Ă„r. Inklusionskriterier for patienter var at de skulle vĂŠre ellers raske, og vĂŠret opereret med enten kolporrafia anterior eller kolporrafia posterior (eller begge). Operationer blev opdelt i 4 grupper, alt efter den mĂŠngde manuel erfaring lĂŠgerne havde (mĂ„lt som gennemsnitligt antal operationer per aktivt Ă„r). BĂ„de PROM og lĂŠgerraporterede parametre blev undersĂžgt efter 1 Ă„r. For at undersĂžge langtidsresultater 5 Ă„r efter operationen, blev et helt nyt spĂžrgeskema designet, valideret, og distribueret nationalt. Information angĂ„ende reoperationsfrekvens blev taget direkte fra GynOp databasen. Resultater: Ved primĂŠre cystoceler, havde operation med kirurgisk mesh bedre resultater end den native operation hvad angĂ„r patienternes prolapssymptomer 1 Ă„r efteroperationen OR 1.53 (95% CI 1.10-2.13), men var ogsĂ„ behĂŠftet med vĂŠsentligt flere operationskomplikationer (OR 1.51, RD=6.6%). For recidiverende rectocele, var mesh ogsĂ„ overlegen den native operation OR 2.06 (95% CI 1.03-4.35), men ikke behĂŠftet med flere komplikationer i kĂžlvandet af operationen. Iblandt de 1092 kirurger der var aktive som Pop operatĂžrer under studiet, opererede 803 (73 %) mindre end 1 gang om mĂ„neden i snit i deres aktive Ă„r. Ingen forskel i patient- eller lĂŠgerapporterede parametre blev set mellem de forskellige erfaringsgrupper. Den overordnede reoperationsfrekvens vist ved Kaplan Meier kurver efter primĂŠre POP operationer var 11,2% efter 5 Ă„r. Svarsfrekvensen pĂ„ spĂžrgeskemaet var 74,9 %. Overordnet efter 5 Ă„r, svarede omkring 70 % af alle patienter at de ikke havde prolapssymptomer, samt 72 %angav at vĂŠre tilfredse med operationsresultatet. Desuden angav 82 % at deres prolapssymptomer var vĂŠsentligt forbedrede i forhold til inden operationen. Diskussion: Resultater af mesh med 1 Ă„rs follow up sammenlignet med nativoperation, er generelt karakteriseret ved en hĂžj grad af symptomfravĂŠr, men varierende grader af ulemper sĂ„som en Ăžget mĂŠngde postoperativ smerte. Dog, unikt for recidiverende rektocele ses ogsĂ„ denne samme hĂžje grad af symptomfrihed, uden nogen umiddelbare ulemper i forhold til den native operation. OperatĂžrens erfaring har ikke nogen indflydelse pĂ„ den native operation, og utilfredsstillende resultater er mere sandsynligt iboende metoden end at dette skal henfĂžres til operatĂžrens mangel pĂ„ erfaring. Resultaterne efter 5 Ă„r indikerer, at kolporrafi producerer meget bedre resultater pĂ„ nationalplan end fĂžrst antaget. Dette bakkes op af bĂ„de de rent objektive data der indikerer et minimalt antal re-operationer i lĂžbet af 5 Ă„r i de mest almindelige tilfĂŠlde (primĂŠre, raske, cystocele og rektocele patienter) og af patienternes egne svar ved 5 Ă„rs followup. Konklusioner- Mesh-operationer er at foretrĂŠkke ved recidiverende rektocele, men har en varierende komplikationsprofil ved primĂŠre operationer, og operationer i andre compartment.- OperatĂžrens manuelle erfaring med nativ-operationer har ingen indflydelse pĂ„ det overordnede resultat af operationen efter 1 Ă„r.- Langtidsresultater efter nativ-operationer er ganske udmĂŠrkede, med en lav risiko for re-operation og et vedholdende fravĂŠr af patientrapporterede symptomer.Hintergrund: Prolaps der weiblichen Beckenorgane (POP) ist eine hĂ€ufige Erkrankung, die sich auf die LebensqualitĂ€t vieler Frauen auswirkt. In Schweden ist das Durchschnittsalter der fĂŒr POP operierten Frauen 60 Jahre. Bei einer Lebenserwartung von etwa 84 Jahren bedeutet dies, dass eined urchschnittliche Patientin weitere 24 Jahre nach der Operation lebt. VerlĂ€ssliche Langzeitergebnisse nach POP-Chirurgie sind daher unentbehrlich. In dem Bestreben, die langfristigen Ergebnisse nach einer Operation fĂŒr Vaginalprolaps zu verbessern, wurden Netzmaterialien zum Einsatz gebracht. In Schweden wird synthetisches Netz bei 7,4 % aller PrimĂ€roperationen verwendet, ohne dass ein kohĂ€renter Konsens ĂŒber deren Verwendung besteht. In Schweden wird die POP-Operation als Routineoperation angesehen, die in fast allen KrankenhĂ€usern durchgefĂŒhrt wird. Ein groĂer Teil der Chirurgen ist unerfahren, 73 % fĂŒhren den Eingriff einmal im Monat oder weniger durch. Gleichzeitig weisen POP-Operationen in globaler Sicht eine hohe Ausfallrate auf. Das Ziel dieser Arbeit ist es zu untersuchen:- Einfluss von netzverstĂ€rkten Operationen auf die operativen Ergebnisse im Vergleich zu Plastiken mit nativem Gewebe.- Hat chirurgische Erfahrung mit POP-Operationen Bedeutung fĂŒr dieoperativen Ergebnisse von Nativoperationen (und in welchem AusmaĂ)?- Langfristige (5-jĂ€hrige) nationale Verlaufskontrolle von native POP Operationen, sowohl in Bezug auf objektive epidemiologische Daten als auch auf die von Patienten gemeldeten Ergebnisse. Methoden: Alle verwendeten Daten wurden aus der Datenbank des Nationalen QualitĂ€tsregisters fĂŒr gynĂ€kologische Chirurgie (GynOp) extrahiert. In Bezug auf die Erfahrungen der Chirurgen mit POP-Operationen wurden ĂŒberneun Jahre kontinuierlich und prospektiv gesammelte GynOp Daten verwendet. Sowohl die vom Chirurgen als auch die vom Patienten berichteten Ergebnisse(PROM) wurden nach einem Jahr analysiert. Einschlusskriterien waren ansonsten gesunde Patienten, bei denen eine Reparatur des anterioren oder posterioren Kompartment (oder beides) mitnativem Gewebe durchgefĂŒhrt wurde. Die Operationen wurden je nach manueller Erfahrung des Chirurgen in vier Gruppen eingeteilt (durchschnittliche Anzahl Operationen pro aktives Jahr).FĂŒr das Langzeit-Follow-up fĂŒnf Jahre nach einer Vorfalloperation wurde ein neuer Fragebogen zur Erfassung von PROM-Daten entworfen, validiert und national angewendet. Informationen zu Reoperationen wurden direkt aus GynOp extrahiert. Ergebnisse: Die netzverstĂ€rkte Operationen einer primĂ€ren Zystozele zeigten ein signifikant besseres Ergebnis in Bezug auf das Fehlen von Prolaps Symptomen im Vergleich zur Operation mit nativen Gewebe, OR 1,53 (95% CI 1,10-2,13), aber auch eine erhöhte Anzahl Komplikationen, die in direktem Zusammenhang mit der Operation standen (OR 1,51; RD = 6,6 %). Bei rezidivierenden Rektozelen war das Netz der Operation mit nativem Gewebe klar ĂŒberlegen OR 2.06 (95% CI 1.03-4.35). Die Anzahl der postoperativen Komplikationen war in beiden Gruppen gleich. Unter den 1 092 Chirurgen, die wĂ€hrend der Studie operativ aktiv waren, nahmen 803 Chirurgen (73 %) in ihren aktiven Jahren einmal im Monat oder weniger an einer POP-Operation teil. Es wurden keine Unterschiede in den von Patienten oder Chirurgen berichteten Ergebnissen zwischen den âErfahrungsgruppenâ festgestellt. Nach fĂŒnf Jahren zeigte eine Kaplan-Meier-Kurve eine chirurgische Reoperationsrate von 11,2 %. Die RĂŒcklaufquote des Patientenfragebogens betrug 74,9 %. Insgesamt gaben 70 % der Patienten keine Symptome an. 72 % und 82 %waren mit den operativen Ergebnissen zufrieden und fĂŒhlten, dass sich ihre Symptome besserten. Diskussion: Die Netzanwendung ist nach einjĂ€hriger Nachsorge im Allgemeinen durch eine hohe Heilungsrate und unterschiedlich schwere Komplikationen sowiepostoperative Schmerzen gekennzeichnet. Bei rezidivierenden Rektozelen wurden jedoch keine unmittelbaren Nachteile der Netzanwendung im Vergleich zur nativen Gewebereparatur festgestellt. Gleichzeitig sieht man signifikant verbesserte Heilungsraten wie in anderen Kompartments. Die Erfahrung des Chirurgen hat keinen Einfluss auf die Ergebnisse bei einer Operation mit nativem Gewebe. Inkonsistente Ergebnisse sind wahrscheinlicher Methode bedingt als dass dies auf mangelnde Erfahrung des Chirurgen zurĂŒckzufĂŒhren wĂ€hre. Die FĂŒnfjahresergebnisse deuten darauf hin, dass fĂŒr primĂ€re Rekto- und Zystozelen die Operation mit nativem Gewebe viel bessere Ergebnisse erbringt als bisher angenommen. Dies wird sowohl durch eine minimale Anzahl von Reoperationen innerhalb von fĂŒnf Jahren untermauert als auch durch die von den Patienten selbst berichteten Ergebnisse. Schlussfolgerungen- Bei rezidivierenden Rektozelen ist eine netzverstĂ€rkte Operation signifikant haltbarer als eine Operation mit nativem Gewebe, mit vergleichbaren Komplikationsprofil. Die Vor- und Nachteile sind fĂŒr die anderen FĂ€llen variierend.- Die operative Erfahrung eines Chirurgen (Anzahl POP Operationen mitnativem Gewebe) hat keinen Einfluss auf das 1-Jahres Ergebnis von Operationen mit nativem Gewebe.- Die Langzeitergebnisse nach POP Operationen mit nativem Gewebe sind ausgezeichnet, mit einem geringen Risiko fĂŒr eine Reoperation und einem anhaltenden Fehlen subjektiver Prolaps Symptomen
Vaginal prolapse surgery : an epidemiological perspective : studies of native tissue repair versus implants, surgeonsÂŽ practical experiences and five year follow-up in the swedish national quality register for gynecological surgery
No full textBackground: Pelvic organ prolapse (POP) is a common condition that impacts on quality of life for many women. The mean age of Swedish women operated for POP is 60 years, and with a life expectancy of approximately 84 years this means that the average patient will live 24 years subsequent to the operation. Therefore, sustainable long-term results of POP surgery are essential. In an effort to improve long-term outcomes of vaginal prolapse surgery, mesh materials have been developed for this purpose. In Sweden, synthetic mesh is used in 7.4% of all primary operations without any coherent consensus about their use. Prolapse surgery is regarded as a routine procedure performed at almost every hospital in Sweden, but a large proportion of the surgeons are inexperienced. In actuality, 73% of them perform the procedure once a month or less frequently. Simultaneously, surgery for POP has been reported to have a highfailure rate internationally. For most surgeons, the operation is a low-frequency procedure, and outcomes have been reported as unsatisfactory. The specific aims of these thesis were to examine:- Mesh-augmented repairs impact on operative results compared to nativetissue repair.- Surgical experience in performing a specific operation and utilize this knowledge in analysing how it may (or may not) affect operative results.- Long-term (5 year) national follow up of POP operations, regarding both the objective epidemiological data and the patient-reported outcomes. Methods: The studies in this thesis are based on data from the Swedish National Quality Register for Gynaecological Surgery (GynOp), which covers approximately 90% of all gynaecological operations in Sweden. The comparative follow-up of POP surgery using non-absorbable polypropylene mesh versus colporrhaphy using native tissue was analysed in two different cohorts, of women with a primary cystocele and women with a relapse after surgery for a rectocele. Both surgeon reported results and patient-reported outcomes (PROMs) were analysed 1 year post-surgery. Information about surgeonsâ experience in performing POP operations was extracted from GynOp over 9 years. Inclusion criteria were otherwise healthy patients who underwent anterior or posterior native tissue repair, or both. The operations were divided into four groups according to the operative experience of the surgeon (measured as average number of operations per active year). Both PROM results and surgeon-reported outcomes after 1 year were investigated. For the long-term follow-up 5 years after any operation for a vaginal prolapse, a new questionnaire to capture PROM data was designed, validated and nationally distributed. Information about re-operations was extracted directly from GynOp. Results: Mesh-augmented repair of a primary cystocele had a significantly better outcome in terms of absence of symptoms, compared with native tissue repair, OR 1.53(95% CI 1.10-2.13), but also had more complications directly related to the procedure (OR 1.51, RD=6.6%). For recurrent rectocele, mesh was superior to native tissue repair, OR 2.06 (95% CI 1.03-4.35); the number of postoperative complications was equal in the two groups. Among the 1,092 surgeons who were active POP surgeons during the study, 803(73%) participated in POP operations once a month or less frequently in their active years. No differences in patient or surgeon-reported outcomes were seen between the âexperience groupsâ. Kaplan-Meier curves for re-operation after a primary POP operation showed an overall retreatment rate of 11.2% after 5 years. The response rate for the patient questionnaire was 74.9%. Overall, 70% of the patients reported no symptoms, and around 72% and 82% were satisfied with the operative results and felt that their symptoms had improved, respectively. Discussion: Mesh use was, after 1 year of follow-up, generally characterized by a high cure rate and varying degrees of complications, such as postoperative pain. However, for recurrent rectocele, we found no immediate drawbacks of the method compared with native tissue repair, with the same high cure rate as seen in other compartments. Surgeon experience had no impact on the native tissue operation, and any inconsistency of outcome is more likely inherent in the method than attributable to a surgeonâs lack of experience.The 5-year results indicate that native tissue repair produces much better results, judging from overall Swedish results, than previously thought. This is backed up both by objective data indicating a minimal number of re-operations within 5 years for the most common cases (i.e. primary rectocele and cystocele) and by the outcomes reported by the patients themselves. Conclusions: Mesh-augmented repair is more effective than native tissue repair forrecurrent rectocele, and without increased risk of complications. Drawbacks of mesh repair vary for other compartments, and for primary operations.- Surgeonsâ operative experience in routine POP operations using native tissue has no impact on outcome after 1 year.- Long-term results of POP repair with native tissue are excellent, with a low risk of re-operation and a persistent absence of subjective symptoms.Bakgrund: Prolaps av bĂ€ckenbottens organ, vaginalprolaps (POP) Ă€r en vanlig Ă„komma ochpĂ„verkar livskvaliteten negativt för mĂ„nga kvinnor. GenomsnittsĂ„ldern för kvinnor som blir opererade för POP Ă€r 60 Ă„r och med en medellivslĂ€ngd pĂ„ cirka 84 Ă„r, betyder detta att den genomsnittliga patienten skall leva 24 Ă„r med operationsresultatet. HĂ„llbara resultat av kirugi över lĂ„ng tid Ă€r dĂ€rför helt essentiell. I ett försök att förbĂ€ttra lĂ„ngtidsresultaten av vaginalprolapsoperationer, blev nĂ€tmaterial (mesh) introducerat. I Sverige blir 7,4 % av alla primĂ€roperationer (första operationen) gjorda med syntetiskt nĂ€tmaterial, utan nĂ„gon samlad konsensus av hur och nĂ€r nĂ€ten skall anvĂ€ndas. I Sverige anses POP-kirurgi vara rutinoperationer, som utförs pĂ„ nĂ€stan alla sjukhus med en stor andel av operatörer med liten eller ingen rutin av operationen. Sammantaget blir 73 % av operationerna som utförs, gjorda avopertörer som i genomsnitt opererar POP en gĂ„ng i mĂ„naden eller mindre. De flesta kirurger opererar alltsĂ„ med lĂ„g frekvens och resultaten anses vara otillfredsstĂ€llande. I ett globalt perspektiv, har rapporterats att operation för vaginalprolaps ofta misslyckas. MĂ„len med avhandlingen var att undersöka:- Inflytande pĂ„ det operativa resultatet nĂ€r nĂ€t anvĂ€nds jĂ€mfört medoperationer utan nĂ€t.- Hur operatörens erfarenhet pĂ„verkar operationsresultat.- En nationell lĂ„ngtidsuppföljning (5 Ă„r) av prolapsoperationer, avseende bĂ„de objektiva epidemiologiska data och patientrapporterade utfall. Metod: Studierna i denna avhandling Ă€r alla baserade pĂ„ data frĂ„n Nationella kvalitetsregistret inom gynekologisk kirurgi (GynOp) som tĂ€cker drygt 90 % av alla gynekologiska operationer utförda i Sverige. De komparativa analyserna av uppföljning av prolapskirurgi efter antingen operation med icke-resorberbar polypropylenmesh (nĂ€t) eller operation utan nĂ€t, blev analyserade i tvĂ„ olika kohorter: Kvinnor med primĂ€r cystocele (framfall urinblĂ„san) och kvinnor med Ă„terfall av rektocele (framfall Ă€ndtarmen). BĂ„de lĂ€karrapporterade resultat och patientrapporterade utfall (PROM) blev analyserade efter 1 Ă„r. Information avseende kirurgens operativa erfarenhet av prolapsoperationer extraherades frĂ„n GynOp databasen under en tidsperiod pĂ„ 9 Ă„r. Avseende patienter var inklusionskriterier att de skulle vara i övrigt friska och genomgĂ„tt antingen frĂ€mre eller bakre plastik, eller en kombination av enbart de tvĂ„. Operationerna blev uppdelade i 4 grupper, efter operatörernas praktiska erfarenhet (genomsnittligt antal operationer per aktivt Ă„r som operatör). BĂ„de PROM och lĂ€karrapporterade resultat efter 1 Ă„r blev analyserade. För att undersöka lĂ„ngtidsresultaten efter operation för vaginalprolaps skapades en ny enkĂ€t, som efter validering distribuerades nationellt till patienter 5 Ă„r efter operationen. Information om reoperationsfrekvenser extraherades direkt frĂ„nGynOp. Resultat: NĂ€toperationer vid primĂ€r cystocele hade signifikant bĂ€ttre resultat ett Ă„r efter operation avseende patientrapporterad frĂ„nvaro av prolapssymptom Ă€n operation utan nĂ€t OR 1.53 (95% CI 1.10-2.13) men det rapporterades ocksĂ„ fler komplikationer relaterade till operationen nĂ€r nĂ€t anvĂ€ndes (OR 1.51, RD=6.6%). För recidiverande rectocele var nĂ€toperation överlĂ€gsen operationer utan nĂ€t OR 2.06 (95% CI 1.03-4.35) MĂ€ngden av postoperativa komplikationer var hĂ€r den samma i bĂ„da operationsgrupperna. Av de 1092 operatörer som var registrerade som aktiva POP operatörer i studien,var 803 (73 %) aktiva i POP operationer enbart 1 gĂ„ng per mĂ„nad eller mindre de Ă„r de var aktiva. Det var ingen mĂ€tbar skillnad mellan âerfarenhetsgrupperâavseende patientrapporterade eller lĂ€karraporterade parametrar. Kaplan Meier kurvor (hĂ„llbarhetskurvor) för reoperationer efter en primĂ€r POP operaton utan nĂ€t, visade en Ă„terbehandlingsfrekvens pĂ„ 11,2 % efter 5 Ă„r. Svarsfrekvensen pĂ„ enkĂ€ten var 74,9 %. Av de som ej behandlats igen med operation hade 70 % av patienterna inga symptom, och respektive 72 % var nöjda med operationsresultaten och 82 % kĂ€nde att deras symptom hade minskat. Diskussion: AnvĂ€ndning av nĂ€t, med 1 Ă„rs uppföljning, jĂ€mfört med utan nĂ€t, karakteriserades av en högre botandegrad, men med fler komplikationer, bland annat postoperativ smĂ€rta. Detta undantaget recidiverande rectocele dĂ€r inga skillnader i komplikationer jĂ€mfört med operationer utan nĂ€t hittades och med samma höga botandegradsom övriga nĂ€toperationer.viiiOperatörens erfarenhet hade inget inflytande pĂ„ operationens resultat, och en eventuellt lĂ„g botandegrad tycks vara mer sannolikt beroende pĂ„ metoden, Ă€n pĂ„ operatörens brist pĂ„ erfarenhet. 5 Ă„rs resultaten indikerar att operationer utan nĂ€t har mycket bĂ€ttre resultat Ă€n hittills kĂ€nt, baserat pĂ„ de övergripande svenska resultaten. Detta stöds av bĂ„de objektiva epidemiologiska data, som indikerar en minimal mĂ€ngd reoperationer inom 5 Ă„r för de vanligaste fallen (sĂ„som primĂ€ra cysto- och rectocele), och av patientens egna svar pĂ„ enkĂ€ten. Konklusioner- NĂ€toperationer Ă€r mer effektiva i att bota recidiverande retocele, och har inga mĂ€tbara nackdelar avseende komplikationer.- Operatörens manuella erfarenhet med operationer utan nĂ€t hade inget inflytande pĂ„ 1 Ă„rs resultaten.- LĂ„ngtidsresultaten efter operation utan nĂ€t Ă€r bra, med lĂ„g risk för reoperation och bestĂ„ende frĂ„nvaro av prolapssymptom efter 5 Ă„r.Baggrund: Prolaps af bĂŠkkenbundens organer (POP) er en almindelig lidelse, der stĂŠrkt pĂ„virker livskvaliteten for mange kvinder. Den gennemsnitlige svenske kvinde opereret for POP er 60 Ă„r ved operationen, og med en forventet gennemsnitlig levealder pĂ„ 84 Ă„r betyder dette, at patienten sandsynligvis vil leve omkring 24 Ă„r med operationsresultaterne. Netop derfor er pĂ„lidelige, holdbare langtidsresultater af operationen essentielle.I et forsĂžg pĂ„ at forbedre isĂŠr langtidsresultater af POP kirurgi, er net (mesh) materialer blevet introduceret. I Sverige bliver 7,4 % af alle primĂŠre operationer opereret med kirurgisk mesh uden nogen Ăžjensynlig konsensus eller ensartethed hvad angĂ„r deres optimale brug.I Sverige bliver POP kirurgi ligeledes anset som rutineoperationer udfĂžrt pĂ„ stort set ethvert hospital med en stor proportion af uerfarne operatĂžrer. I realiteten opererer 73 % af samtlige operatĂžrer, der har noget at gĂžre med POP operationer, mindre end 1 POP-operation om mĂ„neden i gennemsnit. POP er i litteraturen desuden rapporteret at vĂŠre behĂŠftet med en hĂžj rate af mislykkede operationer. Det vil sige, at for de fleste kirurger bliver denne procedure udfĂžrt med meget lav frekvens, og samtidigt er resultaterne Ăžjensynligt utilfredsstillende. MĂ„lene med denne doktorafhandling var at undersĂžge:- Operationsresultater med mesh sammenlignet med operation uden mesh.- LĂŠgens manuelle erfaring med native POP operationer, og hvordan (eller hvordan ikke) den har indflydelse pĂ„ resultaterne.- Langtidsresultaterne (5 Ă„r) pĂ„ national basis for POP operationer, bĂ„de iforhold til de objektive epidemiologiske data og de patientrapporterede udfald. Metoder: BĂ„de de lĂŠgerapporterede og de patientrapporterede resultater (PROM) blev analyseret 1 Ă„r efter operationen. Information angĂ„ende lĂŠgens erfaring med POP blev taget direkte fra GynOp databasen, og er opsamlet over en periode pĂ„ 9 Ă„r. Inklusionskriterier for patienter var at de skulle vĂŠre ellers raske, og vĂŠret opereret med enten kolporrafia anterior eller kolporrafia posterior (eller begge). Operationer blev opdelt i 4 grupper, alt efter den mĂŠngde manuel erfaring lĂŠgerne havde (mĂ„lt som gennemsnitligt antal operationer per aktivt Ă„r). BĂ„de PROM og lĂŠgerraporterede parametre blev undersĂžgt efter 1 Ă„r. For at undersĂžge langtidsresultater 5 Ă„r efter operationen, blev et helt nyt spĂžrgeskema designet, valideret, og distribueret nationalt. Information angĂ„ende reoperationsfrekvens blev taget direkte fra GynOp databasen. Resultater: Ved primĂŠre cystoceler, havde operation med kirurgisk mesh bedre resultater end den native operation hvad angĂ„r patienternes prolapssymptomer 1 Ă„r efteroperationen OR 1.53 (95% CI 1.10-2.13), men var ogsĂ„ behĂŠftet med vĂŠsentligt flere operationskomplikationer (OR 1.51, RD=6.6%). For recidiverende rectocele, var mesh ogsĂ„ overlegen den native operation OR 2.06 (95% CI 1.03-4.35), men ikke behĂŠftet med flere komplikationer i kĂžlvandet af operationen. Iblandt de 1092 kirurger der var aktive som Pop operatĂžrer under studiet, opererede 803 (73 %) mindre end 1 gang om mĂ„neden i snit i deres aktive Ă„r. Ingen forskel i patient- eller lĂŠgerapporterede parametre blev set mellem de forskellige erfaringsgrupper. Den overordnede reoperationsfrekvens vist ved Kaplan Meier kurver efter primĂŠre POP operationer var 11,2% efter 5 Ă„r. Svarsfrekvensen pĂ„ spĂžrgeskemaet var 74,9 %. Overordnet efter 5 Ă„r, svarede omkring 70 % af alle patienter at de ikke havde prolapssymptomer, samt 72 %angav at vĂŠre tilfredse med operationsresultatet. Desuden angav 82 % at deres prolapssymptomer var vĂŠsentligt forbedrede i forhold til inden operationen. Diskussion: Resultater af mesh med 1 Ă„rs follow up sammenlignet med nativoperation, er generelt karakteriseret ved en hĂžj grad af symptomfravĂŠr, men varierende grader af ulemper sĂ„som en Ăžget mĂŠngde postoperativ smerte. Dog, unikt for recidiverende rektocele ses ogsĂ„ denne samme hĂžje grad af symptomfrihed, uden nogen umiddelbare ulemper i forhold til den native operation. OperatĂžrens erfaring har ikke nogen indflydelse pĂ„ den native operation, og utilfredsstillende resultater er mere sandsynligt iboende metoden end at dette skal henfĂžres til operatĂžrens mangel pĂ„ erfaring. Resultaterne efter 5 Ă„r indikerer, at kolporrafi producerer meget bedre resultater pĂ„ nationalplan end fĂžrst antaget. Dette bakkes op af bĂ„de de rent objektive data der indikerer et minimalt antal re-operationer i lĂžbet af 5 Ă„r i de mest almindelige tilfĂŠlde (primĂŠre, raske, cystocele og rektocele patienter) og af patienternes egne svar ved 5 Ă„rs followup. Konklusioner- Mesh-operationer er at foretrĂŠkke ved recidiverende rektocele, men har en varierende komplikationsprofil ved primĂŠre operationer, og operationer i andre compartment.- OperatĂžrens manuelle erfaring med nativ-operationer har ingen indflydelse pĂ„ det overordnede resultat af operationen efter 1 Ă„r.- Langtidsresultater efter nativ-operationer er ganske udmĂŠrkede, med en lav risiko for re-operation og et vedholdende fravĂŠr af patientrapporterede symptomer.Hintergrund: Prolaps der weiblichen Beckenorgane (POP) ist eine hĂ€ufige Erkrankung, die sich auf die LebensqualitĂ€t vieler Frauen auswirkt. In Schweden ist das Durchschnittsalter der fĂŒr POP operierten Frauen 60 Jahre. Bei einer Lebenserwartung von etwa 84 Jahren bedeutet dies, dass eined urchschnittliche Patientin weitere 24 Jahre nach der Operation lebt. VerlĂ€ssliche Langzeitergebnisse nach POP-Chirurgie sind daher unentbehrlich. In dem Bestreben, die langfristigen Ergebnisse nach einer Operation fĂŒr Vaginalprolaps zu verbessern, wurden Netzmaterialien zum Einsatz gebracht. In Schweden wird synthetisches Netz bei 7,4 % aller PrimĂ€roperationen verwendet, ohne dass ein kohĂ€renter Konsens ĂŒber deren Verwendung besteht. In Schweden wird die POP-Operation als Routineoperation angesehen, die in fast allen KrankenhĂ€usern durchgefĂŒhrt wird. Ein groĂer Teil der Chirurgen ist unerfahren, 73 % fĂŒhren den Eingriff einmal im Monat oder weniger durch. Gleichzeitig weisen POP-Operationen in globaler Sicht eine hohe Ausfallrate auf. Das Ziel dieser Arbeit ist es zu untersuchen:- Einfluss von netzverstĂ€rkten Operationen auf die operativen Ergebnisse im Vergleich zu Plastiken mit nativem Gewebe.- Hat chirurgische Erfahrung mit POP-Operationen Bedeutung fĂŒr dieoperativen Ergebnisse von Nativoperationen (und in welchem AusmaĂ)?- Langfristige (5-jĂ€hrige) nationale Verlaufskontrolle von native POP Operationen, sowohl in Bezug auf objektive epidemiologische Daten als auch auf die von Patienten gemeldeten Ergebnisse. Methoden: Alle verwendeten Daten wurden aus der Datenbank des Nationalen QualitĂ€tsregisters fĂŒr gynĂ€kologische Chirurgie (GynOp) extrahiert. In Bezug auf die Erfahrungen der Chirurgen mit POP-Operationen wurden ĂŒberneun Jahre kontinuierlich und prospektiv gesammelte GynOp Daten verwendet. Sowohl die vom Chirurgen als auch die vom Patienten berichteten Ergebnisse(PROM) wurden nach einem Jahr analysiert. Einschlusskriterien waren ansonsten gesunde Patienten, bei denen eine Reparatur des anterioren oder posterioren Kompartment (oder beides) mitnativem Gewebe durchgefĂŒhrt wurde. Die Operationen wurden je nach manueller Erfahrung des Chirurgen in vier Gruppen eingeteilt (durchschnittliche Anzahl Operationen pro aktives Jahr).FĂŒr das Langzeit-Follow-up fĂŒnf Jahre nach einer Vorfalloperation wurde ein neuer Fragebogen zur Erfassung von PROM-Daten entworfen, validiert und national angewendet. Informationen zu Reoperationen wurden direkt aus GynOp extrahiert. Ergebnisse: Die netzverstĂ€rkte Operationen einer primĂ€ren Zystozele zeigten ein signifikant besseres Ergebnis in Bezug auf das Fehlen von Prolaps Symptomen im Vergleich zur Operation mit nativen Gewebe, OR 1,53 (95% CI 1,10-2,13), aber auch eine erhöhte Anzahl Komplikationen, die in direktem Zusammenhang mit der Operation standen (OR 1,51; RD = 6,6 %). Bei rezidivierenden Rektozelen war das Netz der Operation mit nativem Gewebe klar ĂŒberlegen OR 2.06 (95% CI 1.03-4.35). Die Anzahl der postoperativen Komplikationen war in beiden Gruppen gleich. Unter den 1 092 Chirurgen, die wĂ€hrend der Studie operativ aktiv waren, nahmen 803 Chirurgen (73 %) in ihren aktiven Jahren einmal im Monat oder weniger an einer POP-Operation teil. Es wurden keine Unterschiede in den von Patienten oder Chirurgen berichteten Ergebnissen zwischen den âErfahrungsgruppenâ festgestellt. Nach fĂŒnf Jahren zeigte eine Kaplan-Meier-Kurve eine chirurgische Reoperationsrate von 11,2 %. Die RĂŒcklaufquote des Patientenfragebogens betrug 74,9 %. Insgesamt gaben 70 % der Patienten keine Symptome an. 72 % und 82 %waren mit den operativen Ergebnissen zufrieden und fĂŒhlten, dass sich ihre Symptome besserten. Diskussion: Die Netzanwendung ist nach einjĂ€hriger Nachsorge im Allgemeinen durch eine hohe Heilungsrate und unterschiedlich schwere Komplikationen sowiepostoperative Schmerzen gekennzeichnet. Bei rezidivierenden Rektozelen wurden jedoch keine unmittelbaren Nachteile der Netzanwendung im Vergleich zur nativen Gewebereparatur festgestellt. Gleichzeitig sieht man signifikant verbesserte Heilungsraten wie in anderen Kompartments. Die Erfahrung des Chirurgen hat keinen Einfluss auf die Ergebnisse bei einer Operation mit nativem Gewebe. Inkonsistente Ergebnisse sind wahrscheinlicher Methode bedingt als dass dies auf mangelnde Erfahrung des Chirurgen zurĂŒckzufĂŒhren wĂ€hre. Die FĂŒnfjahresergebnisse deuten darauf hin, dass fĂŒr primĂ€re Rekto- und Zystozelen die Operation mit nativem Gewebe viel bessere Ergebnisse erbringt als bisher angenommen. Dies wird sowohl durch eine minimale Anzahl von Reoperationen innerhalb von fĂŒnf Jahren untermauert als auch durch die von den Patienten selbst berichteten Ergebnisse. Schlussfolgerungen- Bei rezidivierenden Rektozelen ist eine netzverstĂ€rkte Operation signifikant haltbarer als eine Operation mit nativem Gewebe, mit vergleichbaren Komplikationsprofil. Die Vor- und Nachteile sind fĂŒr die anderen FĂ€llen variierend.- Die operative Erfahrung eines Chirurgen (Anzahl POP Operationen mitnativem Gewebe) hat keinen Einfluss auf das 1-Jahres Ergebnis von Operationen mit nativem Gewebe.- Die Langzeitergebnisse nach POP Operationen mit nativem Gewebe sind ausgezeichnet, mit einem geringen Risiko fĂŒr eine Reoperation und einem anhaltenden Fehlen subjektiver Prolaps Symptomen
Decisions to use surgical mesh in operations for pelvic organ prolapse : a question of geography?
No full textIntroduction and hypothesis: Surgical mesh can reinforce damaged biological structures in operations for genital organ prolapse. When a method is new, scientific information is often contradictory. Individual surgeons may accept different observations as useful, resulting in conflicting treatment strategies. Additional scientific information should lead to increasing convergence. Methods: Based on data from the Swedish National Quality Register of Gynecological Surgery, all patients who underwent their first recurrent anterior compartment prolapse operation between 2006 and 2017 were included (2758 patients). Surgical mesh was used in 56.5%. We analyzed inter-county disparities in and patterns of mesh use over 12 years. To minimize confounding, we selected a group of highly comparable patients where similar decision patterns could be expected. Results: The use of mesh differed between counties by a factor of 11 (8.6-95.3%). Counties with low use of mesh continued with low use and counties with high use continued with high use. Conclusions: Decisions regarding how to interpret existing scientific information about mesh implants in the early years of mesh use have led to "communities of practice" highly influenced by geographical factors. For 12 years, these groups have made disparate decisions and upheld them without measurable change toward consensus. The scientific learning process has stopped-despite the abundance of new publications and the steady supply of new types of mesh. Ongoing disparity in surgeons' choices in comparable patients has an adverse effect on clinical care. For the patient, this represents 12 years of a geographical lottery concerning whether mesh is used or not
Surgical quality control of minimally invasive procedures, fast-track surgery and implant technology in gynaecological surgery in Sweden
No full textInternationally as well as in Sweden, efforts for improvement in gynaecological surgery in recent decades have mainly focused on three new treatment concepts: (1) Use of minimally invasive procedures: since there is an interdependency between the extent of surgical trauma and the risk for adverse outcome, increased use of supposedly atraumatic endoscopic procedures has revolutionized several aspects of surgical care (2) A multimodal approach to eliminate harmful procedures in the peri-operative process based on evidence-based principles (3) Introduction of implants to support damaged tissue with synthetic mesh in incontinence and pelvic organ prolapse patients. Research question 1: Is introduction of a minimally invasive operation enough per se or is the measured improvement mediated by elimination of harmful procedures in the perioperative process? Findings: Our study (Paper I) indicates that by applying a multimodal intervention programme for the pre- and postoperative care of patients undergoing supravaginal hysterectomy, the surgical procedure per se is of less importance than generally considered. Patient-related parameters such as length of postoperative hospital stay, number of days at home with need of painkillers, number of days before return to normal activities, and patient satisfaction did not differ between patients undergoing the laparoscopic procedure and patients undergoing abdominal supravaginal hysterectomy. When evaluating a new and presumably improved operative procedure against an established standard procedure, it is mandatory and of fundamental importance that the two methods are aligned in terms of perioperative care provided. Research question 2: Under which circumstances can it be assumed that a new surgical procedure showing promising efficacy in one setting can be reproduced with similar results in a different clinical setting (Paper I)? Findings: The operating surgeons concluded that, in their hands and under local conditions, laparoscopic technique for supravaginal hysterectomy was not superior to traditional open hysterectomy and stopped using laparoscopic technique. It seems necessary, prior to routine use, to monitor, using scientific tools, whether the advantages described in the literature are achievable under local conditions. Research question 3: Do expected advantages of implants outweigh the unwanted effects and complications caused by implants in operations for recurrent cystocele (Paper II)? Findings: Mesh has better durability but more (minor) complications. It is not possible to determine whether mesh is "generally better" than native tissue operation. Some may focus on the improved durability, others on the increased risks. The surgeon must make a risk assessment for each individual case. The patient must be sufficiently informed to understand the risks and make a personal, informed decision whether she wants an augmentation by implant. Essential for this process is a clear, comprehensible picture of both desired and unwanted effects of the planned surgery. In this context, studies like ours might be of use
Surgical quality control of minimally invasive procedures, fast-track surgery and implant technology in gynaecological surgery in Sweden
No full textInternationally as well as in Sweden, efforts for improvement in gynaecological surgery in recent decades have mainly focused on three new treatment concepts: (1) Use of minimally invasive procedures: since there is an interdependency between the extent of surgical trauma and the risk for adverse outcome, increased use of supposedly atraumatic endoscopic procedures has revolutionized several aspects of surgical care (2) A multimodal approach to eliminate harmful procedures in the peri-operative process based on evidence-based principles (3) Introduction of implants to support damaged tissue with synthetic mesh in incontinence and pelvic organ prolapse patients. Research question 1: Is introduction of a minimally invasive operation enough per se or is the measured improvement mediated by elimination of harmful procedures in the perioperative process? Findings: Our study (Paper I) indicates that by applying a multimodal intervention programme for the pre- and postoperative care of patients undergoing supravaginal hysterectomy, the surgical procedure per se is of less importance than generally considered. Patient-related parameters such as length of postoperative hospital stay, number of days at home with need of painkillers, number of days before return to normal activities, and patient satisfaction did not differ between patients undergoing the laparoscopic procedure and patients undergoing abdominal supravaginal hysterectomy. When evaluating a new and presumably improved operative procedure against an established standard procedure, it is mandatory and of fundamental importance that the two methods are aligned in terms of perioperative care provided. Research question 2: Under which circumstances can it be assumed that a new surgical procedure showing promising efficacy in one setting can be reproduced with similar results in a different clinical setting (Paper I)? Findings: The operating surgeons concluded that, in their hands and under local conditions, laparoscopic technique for supravaginal hysterectomy was not superior to traditional open hysterectomy and stopped using laparoscopic technique. It seems necessary, prior to routine use, to monitor, using scientific tools, whether the advantages described in the literature are achievable under local conditions. Research question 3: Do expected advantages of implants outweigh the unwanted effects and complications caused by implants in operations for recurrent cystocele (Paper II)? Findings: Mesh has better durability but more (minor) complications. It is not possible to determine whether mesh is "generally better" than native tissue operation. Some may focus on the improved durability, others on the increased risks. The surgeon must make a risk assessment for each individual case. The patient must be sufficiently informed to understand the risks and make a personal, informed decision whether she wants an augmentation by implant. Essential for this process is a clear, comprehensible picture of both desired and unwanted effects of the planned surgery. In this context, studies like ours might be of use
Surgical quality control of minimally invasive procedures, fast-track surgery and implant technology in gynaecological surgery in Sweden
No full textInternationally as well as in Sweden, efforts for improvement in gynaecological surgery in recent decades have mainly focused on three new treatment concepts: (1) Use of minimally invasive procedures: since there is an interdependency between the extent of surgical trauma and the risk for adverse outcome, increased use of supposedly atraumatic endoscopic procedures has revolutionized several aspects of surgical care (2) A multimodal approach to eliminate harmful procedures in the peri-operative process based on evidence-based principles (3) Introduction of implants to support damaged tissue with synthetic mesh in incontinence and pelvic organ prolapse patients. Research question 1: Is introduction of a minimally invasive operation enough per se or is the measured improvement mediated by elimination of harmful procedures in the perioperative process? Findings: Our study (Paper I) indicates that by applying a multimodal intervention programme for the pre- and postoperative care of patients undergoing supravaginal hysterectomy, the surgical procedure per se is of less importance than generally considered. Patient-related parameters such as length of postoperative hospital stay, number of days at home with need of painkillers, number of days before return to normal activities, and patient satisfaction did not differ between patients undergoing the laparoscopic procedure and patients undergoing abdominal supravaginal hysterectomy. When evaluating a new and presumably improved operative procedure against an established standard procedure, it is mandatory and of fundamental importance that the two methods are aligned in terms of perioperative care provided. Research question 2: Under which circumstances can it be assumed that a new surgical procedure showing promising efficacy in one setting can be reproduced with similar results in a different clinical setting (Paper I)? Findings: The operating surgeons concluded that, in their hands and under local conditions, laparoscopic technique for supravaginal hysterectomy was not superior to traditional open hysterectomy and stopped using laparoscopic technique. It seems necessary, prior to routine use, to monitor, using scientific tools, whether the advantages described in the literature are achievable under local conditions. Research question 3: Do expected advantages of implants outweigh the unwanted effects and complications caused by implants in operations for recurrent cystocele (Paper II)? Findings: Mesh has better durability but more (minor) complications. It is not possible to determine whether mesh is "generally better" than native tissue operation. Some may focus on the improved durability, others on the increased risks. The surgeon must make a risk assessment for each individual case. The patient must be sufficiently informed to understand the risks and make a personal, informed decision whether she wants an augmentation by implant. Essential for this process is a clear, comprehensible picture of both desired and unwanted effects of the planned surgery. In this context, studies like ours might be of use
Repair of recurrent rectocele with posterior colporrhaphy or non-absorbable polypropylene mesh : patient-reported outcomes at 1-year follow-up.
No full textINTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the results of repair of isolated, recurrent, posterior vaginal wall prolapse using standard posterior colporrhaphy versus non-absorbable polypropylene mesh in a routine health care setting. METHODS: This cohort study was based on prospectively collected data from the Swedish National Register for Gynaecological Surgery. All patients operated for recurrent, posterior vaginal wall prolapse in Sweden between 1 January 2006 and 30 October 2016 were included. A total of 433 women underwent posterior colporrhaphy, and 193 were operated using non-absorbable mesh. Data up to 1Â year were collected. RESULTS: The 1-year patient-reported cure rate was higher for the mesh group compared with the colporrhaphy group, with an odds ratio (OR) of 2.06 [95% confidence interval (CI) 1.03-4.35], corresponding to a number needed to treat of 9.7. Patient satisfaction (ORâ=â2.38; CI 1.2-4.97) and improvement (ORâ=â2.13; CI 1.02-3.82) were higher in the mesh group. However, minor surgeon-reported complications were more frequent with mesh (ORâ=â2.74; CI 1.51-5.01). Patient-reported complications and re-operations within 12Â months were comparable in the two groups. CONCLUSIONS: For patients with isolated rectocele relapse, mesh reinforcement enhances the likelihood of success compared with colporrhaphy at 1-year follow-up. Also, in our study, mesh repair was associated with greater patient satisfaction and improvement of symptoms, but an increase in minor complications. Our study indicates that the benefits of mesh reinforcement may outweigh the risks of this procedure for women with isolated recurrent posterior prolapse
Impact of surgeon experience on routine prolapse operations
No full textIntroduction and hypothesis: Surgical work encompasses important aspects of personal and manual skills. In major surgery, there is a positive correlation between surgical experience and results. For pelvic organ prolapse (POP), this relationship has to our knowledge never been examined. In any clinical practice, there is always a certain proportion of inexperienced surgeons. In Sweden, most prolapse surgeons have little experience in performing prolapse operations, 74% conducting the procedure once a month or less. Simultaneously, surgery for POP globally has failure rates of 25-30%. In other words, for most surgeons, the operation is a low-frequency procedure, and outcomes are unsatisfactory. The aim of this study was to clarify the acceptability of having a high proportion of low-volume surgeons in the management of POP. Methods: A group of 14,676 exclusively primary anterior or posterior repair patients was assessed. Data were analyzed by logistic regression and as a group analysis. Results: Experienced surgeons had shorter operation times and hospital stays. Surgical experience did not affect surgical or patient-reported complication rates, organ damage, reoperation, rehospitalization, or patient satisfaction, nor did it improve patient-reported failure rates 1 year after surgery. Assistant experience, similarly, had no effect on the outcome of the operation. Conclusions: A management model for isolated anterior or posterior POP surgery that includes a high proportion of low-volume surgeons does not have a negative impact on the quality or outcome of anterior or posterior colporrhaphy. Consequently, the high recurrence rate was not due to insufficient experience of the surgeons performing the operation.Errata: NĂŒssler, E., Eskildsen J. K., NĂŒssler, E. K., Bixo, M., Löfgren, M. Impact of surgeon experience on routine prolapse operations. International Urogynecology Journal 2018;29:2. DOI: 10.1007/s00192-017-3525-y</p
The influence of geographical and clinical factors on decisions to use surgical mesh in operations for pelvic organ prolapse
No full textBackground: Surgical mesh can reinforce damaged biological structures in operations for genital organ prolapse. The first mesh products were cleared by the U.S. Food and Drug Administration in 2002. In contrast to stringent requirements for the development of pharmaceuticals, there was never a systematic scientific evaluation of mesh products. Purpose: We examined whether Swedish gynecological surgeons have transformed increasing amounts of scientific information into common learning, resulting in a convergent and consistent pattern of mesh use. Methods: Based on data from the Swedish National Quality Register of Gynecological Surgery, registered from 2010 to 2016, we examined changes in decisions to use mesh in a largely uniform group of 2864 recurrence patients operated by 455 surgeons, where surgical mesh was used in 1435 patients (50.1%). By means of logistic regression, we explained decisions to use mesh by clinical risk factors, an FDA warning, year of surgery, type of hospital, and geographical factors. Results: The use of mesh in Sweden varied extensively, by a range from 7% to 93% on county level. These disparities were maintained between the entities over time. Different groups of decision makers had drawn different conclusions from the available information. Geography was the most important parameter in explaining decisions to use mesh. Conclusion: Mounting scientific information has had no measurable impact on decision-making, and has not led to a more consistent decision pattern. Early decisions have led to obvious âcommunities of practiceâ at county and region levels. Swedish surgeons, unaltered through 7 years, have made mesh decisions in a clearly biased fashion, highly influenced by geographical factors, and with no measurable change towards national consensus
Long-term outcome after routine surgery for pelvic organ prolapse : A national register-based cohort study
No full textIntroduction and hypothesis: Pelvic organ prolapse (POP) is common, and women have an estimated 12â19% lifetime risk for needing POP surgery. Aims were to measure re-operation rates up to 10 years after POP surgery and patient-reported outcomes (PROMs) 5 years after a first-time operation for POP. Methods: This is a cohort study using the Swedish National Quality Register for Gynaecological Surgery (GynOp). We retrieved information from 32,086 POP-operated women up to 10 years later. After validation, a web-based PROM questionnaire was sent to 4380 women who 5 years previously had standard POP surgery. Main outcome measures were reoperations due to a relapse of prolapse and PROMs 5 years after the primary operation. Results: Among women operated for all types of POP, 11% had re-operations 5 years later and an additional 4% 10 years later, with similar frequencies for various compartments/types of surgery. PROMs yielded a 75% response rate after 5 years. Cure rate was 68% for anterior, 70% for posterior, and 74% for combined anterior-posterior native repairs. Patient satisfaction exceeded 70%, and symptom reduction was still significant after 5 years (p < 0.0001). Conclusions: Following primary prolapse surgery, re-operation rates are low, even after 10 years. A web-based survey for follow-up of PROMs after POP surgery is feasible and yields a high response rate after 5 years. The subjective cure rate after primary POP operations is high, with reduced symptoms and satisfied patients regardless of compartment. Standard prolapse surgery with native tissue repair produces satisfactory long-term results
