Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-26002005 | Other Identifier | The Committees on Health Research Ethics in the Capital Region of Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior colporrhaphy | Active Comparator |
| |
| Collum amputation/Manchester procedure | Active Comparator |
| |
| Anterior colporrhaphy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No postoperative vaginal compression | Other | No vaginal compression through vaginal gauze packing after urogynecolocigal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | Postoperative hospitalization time, defined as the time from the completion of the surgical procedure until the patient is cleared for discharge. | 48 hours |
| Postoperative voiding |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane M. B. F. Gam, MD, PhD | Contact | 00 45 48 29 73 99 | christiane.marie.bourgin.folke.gam@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Christiane M. B. F. Gam, MD, PhD | Departement og Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology-Obstetrics, Copenhagen University Hospital - North Zealand | Hillerød | Copenhagen | 3400 | Denmark |
Permission not sought at ethical comittee.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Semi-masked as surgeon will only know 5 minutes before surgery ends whther patient has been randomized to intervention or not.
| Postoperative vaginal compression | Other | Postoperative vaginal compression through vaginal gauze packing after urogynecolocigal surger |
|
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.
| 48 hours |
| Postoperative pain | Measured once per hour until discharge by visual analog scale score. | 48 hours |
| Urinary tract infection | UTI measured by self-reporting or prescription issuance. | 3 months |
| Postoperative complications | Postoperative outpatient contacts due to a complication or suspicion of a postoperative complication. | 3-6 months |