Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial

Study Question: Does septum resection improve reproductive outcomes in women with a septate uterus? Summary Answer: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. What is Known Already: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. Study Design, Size, Duration: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. Participants/Materials, Setting, Methods: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. Main Results and the Role of Chance: We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%). Limitations, Reasons for Caution: Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance. Wider Implications of the Findings: The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery.J.F.W. Rikken, C.R. Kowalik, M.H. Emanuel, M.Y. Bongers, T. Spinder, F.W. Jansen, A.G.M.G.J. Mulders, R. Padmehr, T.J. Clark, H.A. van Vliet, M.D. Stephenson, F. van der Veen, B.W.J. Mol, M. van Wely, and M. Goddij

The randomised uterine septum transsection trial (TRUST): Design and protocol

Background: A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus. Methods/design: A multi-centre randomised contr

Are polypropylene mesh implants associated with systemic autoimmune inflammatory syndromes? A systematic review

Purpose: The surgical implantation of polypropylene (PP) meshes has been linked to the occurrence of systemic autoimmune disorders. We performed a systematic review to determine whether PP implants for inguinal, ventral hernia or pelvic floor surgery are associated with the development of systemic autoimmune syndromes. Methods: We searched Embase, Medline, Web of Science, Scopus, Cochrane library, clinicaltrialsregister.eu, clinicaltrails.gov and WHO-ICTR platform. Last search was performed on November 24th 2021. All types of studies reporting systemic inflammatory/autoimmune response in patients having a PP implant for either pelvic floor surgery, ventral or inguinal hernia repair were included. Animal studies, case reports and articles without full text were excluded. We intended to perform a meta-analysis. The quality of evidence was assessed with the Newcastle–Ottawa Scale. This study was registered at Prospero (CRD42020220705). Results: Of 2137 records identified, 4 were eligible. Two retrospective matched cohort studies focused on mesh surgery for vaginal prolapse or inguinal hernia compared to hysterectomy and colonoscopy, respectively. One cohort study compared the incidence of systemic conditions in women having urinary incontinence surgery with and without mesh. These reports had a low risk of bias. A meta-analysis showed no association when comparing systemic disease between mesh and control groups. Calculated risk ratio was 0.9 (95% CI 0.82–0.98). The fourth study was a case series with a high risk of bias, with a sample of 714 patients with systemic disease, 40 of whom had PP mesh implanted. Conclusion: There is no evidence to suggest a causal relationship between being implanted with a PP mesh and the occurrence of autoimmune disorders

Prediction of successful revision surgery for mesh-related complaints after inguinal hernia and pelvic organ prolapse repair

Purpose With this retrospective case series, we aim to identify predictors for reduction of pain after mesh revision surgery in patients operated for inguinal hernia or pelvic organ prolapse with a polypropylene implant. Identifying these predictors may aid surgeons to counsel patients and select appropriate candidates for mesh revision surgery.Methods Clinical records before and after mesh revision surgery from 221 patients with chronic postoperative inguinal pain (CPIP) and 59 patients with pain after pelvic organ prolapse (POP) surgery were collected at two experienced tertiary referral centers. Primary outcome was patient reported improvement of pain after revision surgery. A multivariable logistic regression model was used to specify predictors for pain reduction.Results The multivariable logistic regression was performed for each patient group separately. Patients with CPIP had higher chances of improvement of pain when time between mesh placement and mesh revision surgery was longer, with an OR of 1.19 per year. A turning point in chances of risks and benefits was demonstrated at 70 months, with improved outcomes for patients with revision surgery >= 70 months (OR 2.86). For POP patients, no statistically significant predictors for reduction of pain after (partial) removal surgery could be identified.Conclusion A longer duration of at least 70 months between implantation of inguinal mesh and revision surgery seems to give a higher chance on improvement of pain. Caregivers should not avoid surgery based on a longer duration of symptoms when an association between symptoms and the location of the mesh is found

Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic (R) compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study

Objective: To investigate the costeffectiveness of urethral bulking polydimethylsiloxaneUrolastic (R) (PDMS- U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1 year follow up.Design: Prospective, two arm cohort study with 2 year follow up.Setting: International multicentre.Population: Women with moderate to severe SUI.Main outcome measures: Primary outcome was subjective cure (Patient Global Impression of Improvement). Secondary outcomes: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI- 6), complications and re interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D 5L, incremental costeffectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). Results: In all, 131 PDMS- U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS- U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS- U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS- U and MUS surgery were euro 3567 and euro 6688. ICER for MUS surgery cost euro 15 598 per IIQ QALY and euro 37 408 per EQ- 5D- 5L QALY. With a willingness to pay (WTP) of euro 25 000, MUS has a 84% chance of being costeffective using IIQ, whereas PDMS- U has a 99% chance of being costeffective using EQ-5D-5L.Conclusion: MUS surgery is more costeffective in realising improved disease specific quality of life (QoL), while PDMS- U is more costeffective in realising improved generic QoL

Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL

Septum resection versus expectant management in women with a septate uterus : an international multicentre open-label randomised controlled trial

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. WHAT IS KNOWN ALREADY: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. STUDY DESIGN, SIZE, DURATION: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE: We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%). LIMITATIONS, REASONS FOR CAUTION: Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance. WIDER IMPLICATIONS OF THE FINDINGS: The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery

The transformation of post-communist economies in a globalised economy : the case of Poland

This article argues that the transformation of the economies of Central and Eastern Europe (CEE) has to be understood in the context of the dynamics and development of the global economy. The analysis draws on the notion of combined and uneven development in which there has recently been renewed interest. Too often this notion has been a slogan that lacks substance, but the article elaborates how change is a dynamic process of interaction between economic change and political and social forces. The neoliberal analysis, as well as some Marxist accounts, are criticised for being deterministic, linear and prescriptive. This account emphasises the institutional dimension and role of the state as being critical to understanding the varied outcomes between and within economies in CEE in terms of the way that it has mediated the reinsertion of these countries into the global economy. The story focuses on agency, a neglected aspect of analysis, in emphasising the ideological and discursive aspects of transformation, which attempt to justify and reinforce economic and material changes and to close down debate about alternatives. Crucially, the form and content of development, in its widest sense, cannot be known or predicted because the process of transformation has been contested by different factions of the ruling class and by workers. Despite the marginalisation of organised labour in mainstream and many radical accounts, it is argued that trade unions and workers have been central to the process and outcomes of transformationNon peer reviewe