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Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

NCT05688059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-04-13

No results posted yet for this 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.

Conditions

  • Pelvic Organ Prolapse
  • Uterovaginal Prolapse
  • Vaginal Vault Prolapse
  • Cystocele

Interventions

OTHER

Absorbable Suture and Permanent Suture

Absorbable Suture and Permanent Suture

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Laura Dhariwal, MD · Atlantic Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2025-01-09
Completion
2025-01-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688059 on ClinicalTrials.gov