Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Age ≥ 18
- Females
- Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers
Exclusion criteria
- Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
- Patients with current gynecologic malignancies
- Patients with history of pelvic radiation
- Patients with history of prolapse repair surgery
Trial design
Primary purpose
Allocation
Interventional model
Masking
49 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Kaythi Khin, DO
Data sourced from clinicaltrials.gov
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