Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER) : study protocol for a multicentre, double-blinded, randomized controlled trial

Background: Despite the fact that emergency midline laparotomy is a risk factor for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published thus far. Method: The PREEMER trial (registration number NCT04311788) is a multicentre, patient- and assessor-blinded, randomized controlled trial to be conducted in six hospitals in Finland. A total of 244 patients will be randomized at a 1 : 1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small-stitch 4 : 1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incidence of incisional hernia 2 years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical-site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related reoperations within the 2- and 5-year follow-ups; the incidence of incisional hernia within the 5-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale and the PROMIS questionnaire within 30 days and 2 and 5 years from surgery. Additionally, health-economic explorative measures will be explored. Conclusion: The PREEMER trial will provide level 1 evidence on incisional hernia prevention in an emergency setting.Peer reviewe

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia : a prospective randomised multicentre study, 1-year results

Purpose Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR. Methods This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured. Results At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p <0.001) and physical functioning by 4.3 points (p = 0.014). Conclusion Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL. Trial Registry: Clinical trial number NCT02542085.Peer reviewe

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results

Purpose Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR.Methods This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured.Results At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p Conclusion Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL.</p

Surgical treatment of incisional ventral hernia:with a special reference to laparoscopic techniques

Abstract An incisional hernia is a common complication following abdominal surgery. A hernia repair is recommended for the risk of incarceration. There are several operative methods. The laparoscopic technique is in wide use, but it is associated with a risk of enterotomy. Seroma formation is a common postoperative finding. In the hybrid technique, adhesions can be lysed and the fascial defect sutured through a mini-incision prior to mesh augmentation. In this thesis, we evaluate the complications associated with hernia repair operations, focusing on laparoscopic methods. We explore whether seroma formation and hernia recurrence could be diminished using the hybrid method. Study I was a descriptive analysis of 127 claims concerning ventral hernioplasties reported to the Finnish Patient Insurance Centre from 2003–2010. In Study II, we analysed 818 incisional hernia repairs, focusing on major complications. In Study III, the results of 38 laparoscopic and 24 hybrid operations in cases featuring complex adhesiolysis were compared. In prospective multicentre Studies IV–V, 193 operations randomised to either the laparoscopic or hybrid technique were analysed. In retrospective Studies I–III, we found that major complications were related to undetected enterotomies. Complex adhesions had a significant influence on major complications, enterotomies, and surgical site infections. In Studies IV–V, five enterotomies occurred in laparoscopic operations compared to one in hybrid operations. Adhesiolysis was described clearly more often complex in the laparoscopic group than in the hybrid group. After laparoscopy, there were significantly more seromas when compared to the hybrid operations. After one year, no difference in hernia recurrence was seen between the groups. Eleven (6.4%) recurrent hernias were detected: six in the laparoscopic group and five in the hybrid group. Laparoscopic operations carry a low complication rate, but the risk of enterotomy is still apparent, especially in cases in which intense adhesions are present. A hybrid operation offers a safe approach to lyse adhesions by hand, and therefore the risk of enterotomy low. Seroma formation is clearly diminished after hybrid operations, but its influence on hernia recurrence requires a longer follow-up period. Patients are pain-free following hernia repair, resulting in their better quality of life.Tiivistelmä Arpityrä on yleinen leikkauskomplikaatio, ja sen korjaamista suositellaan kureutumisriskin vuoksi. Leikkaustekniikoita on useita. Suosittuun tähystysleikkaustekniikkaan tiedetään liittyvän vakavan komplikaation, suolivaurion riski. Leikkausalueen nestekertymä on yleinen löydös leikkauksen jälkeen. Hybriditekniikassa kiinnikkeiden irrottelu tehdään pienen avauksen kautta ja tyräaukko suljetaan ennen verkon kiinnittämistä. Tutkimuksessa arvioimme tyräleikkauskomplikaatioita keskittyen tähystysleikkaustekniikoihin. Selvitimme voiko hybriditekniikkaa käyttäen vähentää leikkauksen jälkeisen nestekertymän muo-dostumista ja tyrän uusiutumista. Osatyö I kuvaili Potilasvakuutuskeskukseen vuosina 2003–2010 ilmoitettuja vatsan tyräleikkauksiin liittyviä vahinkoja (n = 127). Osatyössä II analysoimme 818 tyränkorjausleikkauksen tulokset keskittyen vakaviin komplikaatioihin. Osatyössä III verrattiin 38 tähystys- ja 24 hybridileikkauksien tuloksia tilanteissa, joissa todettiin hankalat kiinnikkeet. Prospektiivisessa monikeskustutkimuksessa (osatyöt IV–V) 193 potilasta leikattiin satunnaistamisen mukaan tähystys- tai hybriditekniikkaa käyttäen. Retrospektiivisissä osatöissä I–III totesimme, että tähystysleikkauksien vakavat komplikaatiot liittyivät huomaamatta jääneisiin suolivaurioihin. Hankalilla kiinnikkeillä todettiin selkeä yhteys vakaviin komplikaatioihin, suolivaurioihin ja haavainfektioihin. Prospektiivisissa osatöissä IV–V kuvattiin viisi suolivauriota tähystysleikkauksien ja yksi hybridileikkauksien yhteydessä. Kiinnikkeiden irrottelu oli selvästi hankalampaa tähystysleikkauksissa. Tähystysleikkausten jälkeen todettiin selvästi enemmän leikkausalueen nestekertymiä verrattuna hybridileikkauksiin. Vuoden kohdalla tyräuusiutumien määrässä ei ollut eroja ryhmien välillä; 11 (6,4 %) tyräuusiutumasta kuusi todettiin tähystys- ja viisi hybridiryhmässä. Toteamme, että tähystysleikkauksiin liittyviä komplikaatiota on vähän, mutta suolivaurion riski on kohonnut leikkauksissa, joissa todetaan runsas kiinnikkeisyys. Hybriditekniikassa kiinnikkeiden irrottelu käsin voi vähentää suolivaurion riskiä. Nestekertymän ilmaantuminen leikkausalueelle on selvästi vähäisempää hybridileikkauksen jälkeen, mutta sen vaikutus tyrän uusiutumisriskiin vaatii pidemmän seuranta-ajan. Potilaat ovat kivuttomia tyränkorjausleikkauksen jälkeen, mikä näkyy elämänlaadun kohenemisena

Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER):study protocol for a multicentre, double-blinded, randomized controlled trial

Abstract Background: Despite the fact that emergency midline laparotomy is a risk factor for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published thus far. Methods: The PREEMER trial (registration number NCT04311788) is a multicentre, patient- and assessor-blinded, randomized controlled trial to be conducted in six hospitals in Finland. A total of 244 patients will be randomized at a 1 : 1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small-stitch 4 : 1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incidence of incisional hernia 2 years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical-site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related reoperations within the 2- and 5-year follow-ups; the incidence of incisional hernia within the 5-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale and the PROMIS questionnaire within 30 days and 2 and 5 years from surgery. Additionally, health–economic explorative measures will be explored. Conclusions: The PREEMER trial will provide level 1 evidence on incisional hernia prevention in an emergency setting. Registration number: NCT04311788 (http://www.clinicaltrials.gov). Registered 7 March 202