NCT07006129

Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40,646 (actual)
• Sponsor: Lund University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy is not strictly indicated but clinically tenable, perioperatively are randomized to concomitant perineorrhaphy or not.

Detailed description

This is an emulated pragmatic open-label two-arm trial in patients undergoing native tissue repair surgery for pelvic organ prolapse, in which patients are randomized perioperatively to either concomitant perineorrhaphy or not. The target population is the large group of patients for whom, at the discretion of the surgeon, this intervention is currently an option while not being strictly indicated. The investigators assumed that women were randomly assigned perioperatively to either strategy within levels of baseline co-variables: age, BMI, parity, lung disease, ASA-classification, constipation, hypermobility, prolapse in which vaginal compartment and if surgery is performed on it, year of primary surgery and region. Data was obtained from The Swedish National Quality Register of Gynaecological Surgery (GynOp), the Swedish National Patient Register, the Swedish Medical Birth Register, and the Swedish Cause of Death Register. In order to emulate a target trial, multiple imputation of missing data is followed by controlling for confounding through inverse probability weighting (IPW) in order to estimate the average treatment effect (ATE) in the primary analysis. In the secondary analysis, the primary analysis will be repeated but with overlap weights. Additional analyses: The sample will be re-weighted using IPW to estimate the average treatment effect on the treated (ATT). Restricted mean survival time (RMST) will be calculated at five years of follow-up for the primary outcome. Bias analysis: Mortality during follow up for the primary outcome will be used as a negative control.

Conditions

• Pelvic Organ Prolapse Vaginal Surgery
• Pelvic Organ Prolapse (POP)

Interventions

Type	Name	Description
PROCEDURE	Perineorrhaphy	Concomitant perineorrhaphy
PROCEDURE	No perineorrhaphy	No concomitant perineorrhaphy

Timeline

• Start date: 2007-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: Sweden