Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

Absorbable Suture and Permanent Suture

Clinical Study ID

NCT05688059

1963079-1

Ages > 18
Female

Study Summary

Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications.

Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture.

Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18
Females
Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligamentsuspension procedure at Morristown and Overlook Medical Centers

Exclusion

Exclusion Criteria:

Patients who did not undergo sacrospinous ligament suspension procedure based onsurgeon's intraoperative decision
Patients with current gynecologic malignancies
Patients with history of pelvic radiation
Patients with history of prolapse repair surgery

Study Design

Absorbable Suture and Permanent Suture

January 06, 2023

January 09, 2025

Study Description

Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system.

Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6.

Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded.

All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon.

Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed.

Follow up exams will occur at 2-4 weeks, 12 weeks and 12 months post-operatively. The follow up visits will include a POP-Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI-I questionnaire. All participants will also be assessed for any suture-related complications. 12 month POP-Q exam will be completed by one of the providers who will be blinded to the suture type.

There will be no additional follow up visits for participation in the study. The follow up appointments at 2-4 weeks, 12 weeks and 12 months are the times of usually scheduled post-operative follow up.

Connect with a study center

Atlantic Health System
Morristown, New Jersey 07960
United States
Site Not Available

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