Postoperative Vaginal Compression After Prolapse Surgery - an RCT

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChristiane Marie Bourgin Folke Gam

About this trial

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.

Eligibility criteria

Qualifiers

Planned anterior colporrhaphy, posterior colporrhaphy, or cervical amputation at the day surgery department, Nordsjællands Hospital, Capital Region, Denmark

Age 18 years and older

Received information material as described in the protocol

Disqualifiers

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

Trial design

Treatments tested in this trial

  • No postoperative vaginal compression
  • Postoperative vaginal compression

Treatment groups

360 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Christiane Marie Bourgin Folke Gam

Lead sponsor

Nordsjaellands Hospital

Sponsor institution

Nordsjaellands Hospital

Collaborator