Clinical trial NCT07006129: Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
Official title: Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse Vaginal Surgery
Pelvic Organ Prolapse (POP)
Keywords: Target Trial Emulation
Pelvic organ prolapse
Perineorrhaphy
Vaginal surgery
Cystocele
Rectocele
Apical prolapse
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 40646
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with their primary vaginal pelvic organ prolapse surgery registered in the Swedish National Quality Register of Gynaecological Surgery (GynOp).

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation
timeFrame: 5 years
Secondary outcomes:
measure: Symptoms of a vaginal bulge (patient reported outcome)
timeFrame: At 1 year
measure: Unsatisfied (patient reported outcome)
timeFrame: At 1 year
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Lund University
Study officials:
References: