NCT05586984

Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension

A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.

Detailed description

Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.

Conditions

• Pelvic Organ Prolapse
• Uterine Prolapse

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic uterine lateral suspension	Laparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm\*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed.
PROCEDURE	Transvaginal sacrospinous fixation	Transvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed.

Timeline

• Start date: 2022-07-26
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2022-10-19
• Last updated: 2022-10-21

Locations

1 site across 1 country: Taiwan