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NCT Number: NCT05688059

Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

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.

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Key information

Conditions

Pelvic Organ Prolapse Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Uterovaginal Prolapse Vaginal Vault Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Health System

Morristown, New Jersey, 07960, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Absorbable Suture and Permanent Suture

Other

Absorbable Suture and Permanent Suture

Primary outcomes

  1. Pelvic Organ Prolapse Quantification (POP-Q) exam Point C

    Time frame: 12 months

    Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.

Secondary outcomes

  1. Prolapse Recurrence

    Time frame: 12 months

    Defined as: Prolapse symptoms reported by patient, Prolapse beyond the hymen on examination in any compartment , Apical prolapse ≥ ½ TVL, Reoperation or pessary use for prolapse during the study period

  2. PGI-I

    Time frame: 12 months

    patient's global impression of symptom improvement

  3. Suture-related Complications

    Time frame: 12 months

    presence of abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia, if they can feel sutures. On the physical exam, patients will be evaluated for apical granulation tissue, and apical suture exposure.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

Is Absorbable Suture Non-Inferior to Permanent Suture in Sacrospinous Ligament Suspension? A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2023
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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