Vaginal Vault Prolapse Surgical Treatment

CompletedOBSERVATIONAL
Enrollment

64

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

June 30, 2022

Study Completion Date

September 30, 2024

Conditions
Vaginal Vault ProlapsePelvic Floor Prolapse
Interventions
PROCEDURE

vNOTES high uterosacral ligament suspension

Following the entry into the peritoneal cavity via apical colpotomy, a transvaginal retractor was inserted through the vaginal vault and the vaginal access platform was established. The ureters and uterosacral ligaments (USL) were identified via laparoscopic view. Bilateral nonabsorbable sutures were placed by the intermediate portions of the USL at the level of the ischial spines making up a total of 4 stitches (Figure 1). Then, the sutures were slightly weighed to verify proper placement. Then, the V-notes platform was removed and the peritoneum was closed. The aforementioned sutures were fixed to the ipsilateral cardinal ligament stump and the pubocervical fascia on the anterior wall. Finally, the previously mentioned nonabsorbable sutures were attached to the vaginal cuff and tied. Routine postoperative cystoscopy was performed.

PROCEDURE

Laparoscopic lateral suspension

The polypropylene mesh used had a width of 2.5 cm and a length of 25 cm. The vaginal cuff was suspended. Blunt dissection was applied to develop vesicovaginal and rectovaginal spaces. The middle part of the mesh was placed flatly in the vesicovaginal space, and fixed with non-absorbable sutures. An atraumatic laparoscopic instrument was inserted through skin incisions of approximately 2-3 mm approximately 3 cm above and 4 cm lateral to the anterior superior iliac spine, followed by perforation only of the aponeurosis of the external oblique muscle and retroperitoneal advancement of the instrument through the lateral abdominal wall. Under laparoscopic visualization, the instrument moved through the bilateral tension-free retroperitoneal tunnels created. The lateral arms of the mesh were secured bilaterally to the aponeurosis of the external oblique muscle and behind the anterior superior iliac spine. Finally, the peritoneum was closed.

Trial Locations (1)

34785

Arzu Bilge Tekin, Istanbul

All Listed Sponsors
lead

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

NCT06792331 - Vaginal Vault Prolapse Surgical Treatment | Biotech Hunter | Biotech Hunter