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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
360
No vaginal compression through vaginal gauze packing after urogynecolocigal surgery
Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
Hillerød, Copenhagen, Denmark
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
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
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
Postoperative pain
Measured once per hour until discharge by visual analog scale score.
Time frame: 48 hours
Urinary tract infection
UTI measured by self-reporting or prescription issuance.
Time frame: 3 months
Postoperative complications
Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication.
Time frame: 3-6 months
Christiane M. B. F. Gam, MD, PhD
CONTACT
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