Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Conditions
Keywords
Target Trial Emulation, Pelvic organ prolapse, Perineorrhaphy, Vaginal surgery, Cystocele, Rectocele, Apical prolapse
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.
Interventions
PROCEDUREPerineorrhaphy
Concomitant perineorrhaphy
PROCEDURENo perineorrhaphy
No concomitant perineorrhaphy
Sponsors
Lund University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation | 5 years | Reported as absolute risk difference, with cumulative risks during five years of follow-up estimated using the Kaplan-Meier estimator. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp) and the Swedish National Patient Register. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of a vaginal bulge (patient reported outcome) | At 1 year | Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp). |
| Unsatisfied (patient reported outcome) | At 1 year | Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp). |
Countries
Sweden
Outcome results
None listed