Postoperative Vaginal Compression After Prolapse Surgery - an RCT

Christiane Marie Bourgin Folke Gam

Status: Not yet enrolling

Conditions: Urogynecologic Surgery; Postoperative Care; Prolapse Genital

Treatments: Other: No postoperative vaginal compression; Other: Postoperative vaginal compression

Study type: Interventional

Funder types: Other

Identifiers

NCT07612202

p-2026-21529

H-26002005 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Posterior colporrhaphy

Active Comparator group

Treatment:

Other: Postoperative vaginal compression

Other: No postoperative vaginal compression

Collum amputation/Manchester procedure

Active Comparator group

Treatment:

Other: Postoperative vaginal compression

Other: No postoperative vaginal compression

Anterior colporrhaphy

Active Comparator group

Treatment:

Other: Postoperative vaginal compression

Other: No postoperative vaginal compression