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Postoperative Vaginal Compression After Prolapse Surgery - an RCT

ConditionsPostoperative CareProlapse GenitalUrogynecologic Surgery
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • No postoperative vaginal compression

    Other intervention

    No vaginal compression through vaginal gauze packing after urogynecolocigal surgery

  • Postoperative vaginal compression

    Other intervention

    Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Posterior colporrhaphyActive comparator 2 interventions
Group B: Collum amputation/Manchester procedureActive comparator 2 interventions
Group C: Anterior colporrhaphyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Reccurence of prolapse 3 months postoperatively

Prolapse recurrence within the first 3 months postoperatively, defined as one of the following: new treatment for prolapse (pessary or surgery), or prolapse grade 3 or greater, or prolapse grade 2 with concurrent prolapse symptoms.

Time frame
3-6 months

Secondary outcomes

1

Time to discharge

Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge.

Time frame
48 hours
2

Postoperative voiding

Number of voidings, voided volume and residual urine volume (measured by abdominal ultrasound scan). Time to first normal voiding, defines as residual urine volume \< 150 ml by ultrasound when voiding twice that volume.

Time frame
48 hours
3

Postoperative pain

Measured once per hour until discharge by visual analog scale score.

Time frame
48 hours
4

Urinary tract infection

UTI measured by self-reporting or prescription issuance.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christiane Marie Bourgin Folke Gam

Lead sponsor

Nordsjaellands Hospital

Sponsor institution

Nordsjaellands Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: