Postoperative Vaginal Compression After Prolapse Surgery - an RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No postoperative vaginal compression, Postoperative vaginal compression.
- Who it may be relevant to
- Registry conditions: Postoperative Care, Prolapse Genital, Urogynecologic Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial on Postoperative Vaginal Compression After Prolapse Surgery
Overview
The goal of this clinical trial is to learn if omitting postoperative vaginal compression (packing) can facilitate a more efficient recovery after elective surgery for uterovaginal prolapse. The main questions it aims to answer are: Will the omission of vaginal compression result in a non-inferior (unchanged) rate of prolapse recurrence within the first three months after surgery? Does the omission of vaginal compression lead to a shorter hospital stay and a faster return of normal bladder function? Researchers will compare a group that receives no postoperative vaginal compression to a control group that receives standard vaginal gauze packing for two hours to see if skipping the packing leads to shorter hospital stays and faster bladder emptying without increasing the risk of the prolapse returning.
Interventions
- Other No postoperative vaginal compression
No vaginal compression through vaginal gauze packing after urogynecolocigal surgery - Other Postoperative vaginal compression
Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
Primary outcome measures
- Reccurence of prolapse 3 months postoperatively [Time frame: 3-6 months]
Secondary outcome measures (5)
- Time to discharge [Time frame: 48 hours]
- Postoperative voiding [Time frame: 48 hours]
- Postoperative pain [Time frame: 48 hours]
- Urinary tract infection [Time frame: 3 months]
- Postoperative complications [Time frame: 3-6 months]
Eligibility criteria
Inclusion criteria
- Planned anterior colporrhaphy, posterior colporrhaphy, or cervical amputation at the day surgery department, Nordsjællands Hospital, Capital Region, Denmark
- Age 18 years and older
. Cognitively capable patient
- Received information material as described in the protocol
Exclusion criteria
- Failure to pause blood-thinning medication on the day of surgery, if this was planned
- Failure to discontinue regular intake of fish oil or ginger extract four weeks prior to the procedure
- Immunosuppressed patients
- Planned perineorrhaphy
- Surgery involving more than two compartments
- Non-Danish speaking patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand — Hillerød
Identifiers
NCT: NCT07612202 · p-2026-21529 · H-26002005