Postoperative Care, Prolapse Genital, Urogynecologic Surgery
Conditions
Keywords
postoperative, randomised ccontrolled trial, vaginal compression, prolapse surgery
Brief summary
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
OTHERNo postoperative vaginal compression
No vaginal compression through vaginal gauze packing after urogynecolocigal surgery
OTHERPostoperative vaginal compression
Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger
Sponsors
Christiane Marie Bourgin Folke Gam
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Semi-masked as surgeon will only know 5 minutes before surgery ends whther patient has been randomized to intervention or not.
Intervention model description
The study includes 3 arms : 1) patients planned for anterior colporrhaphy 2) patients planned for posterior colporrhaphy and 3) patients planned for collum amputation/Manchester procedure. Each arm is randomized to either postoperative vaginal compression or the omission of it.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reccurence of prolapse 3 months postoperatively | 3-6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | 48 hours | Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge. |
| Postoperative voiding | 48 hours | 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. |
| Postoperative pain | 48 hours | Measured once per hour until discharge by visual analog scale score. |
| Urinary tract infection | 3 months | UTI measured by self-reporting or prescription issuance. |
| Postoperative complications | 3-6 months | Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication. |
Countries
Denmark
Contacts
CONTACTChristiane M. B. F. Gam, MD, PhD
PRINCIPAL_INVESTIGATORChristiane M. B. F. Gam, MD, PhD
Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand
Outcome results
None listed