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NCT05688059
Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension
Conditions: Pelvic Organ Prolapse, Uterovaginal Prolapse, Vaginal Vault Prolapse, Cystocele
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: Atlantic Health System
Location: United States
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 Criteria:Age ≥ 18FemalesPatients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical CentersExclusion Criteria:Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decisionPatients with current gynecologic malignanciesPatients with history of pelvic radiationPatients with history of prolapse repair surgery
Source: ClinicalTrials.gov (NCT05688059). StuddyBuddy aggregates publicly available trial information.