Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40646 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Organ Prolapse Vaginal Surgery Pelvic Organ Prolapse (POP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Perineorrhaphy

Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair including perineorrhaphy

Perineorrhaphy

Intervention Type PROCEDURE

Concomitant perineorrhaphy

No perineorrhaphy

Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair excluding perineorrhaphy

No perineorrhaphy

Intervention Type PROCEDURE

No concomitant perineorrhaphy

Interventions

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Perineorrhaphy

Concomitant perineorrhaphy

Intervention Type PROCEDURE

No perineorrhaphy

No concomitant perineorrhaphy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pelvic organ prolapse surgery with vaginal native tissue repair without concomitant hysterectomy.

Exclusion Criteria

* Primary surgery with colpocleisis, use of mesh, laparoscopic or abdominal surgery, concomitant incontinence surgery (eg transvaginal tape).
* Previous hysterectomy
* Previous pelvic organ prolapse surgery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No