LOOP VS DOUBLE SUTURE TECHNIQUES IN SACROSPINOUS FIXATION: A TWO-YEAR STUDY

NCT07106866 | Completed

• 1 other identifier: SSFtecnique
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study aimed to compare clinical outcomes between the classical double suture technique and a modified loop suture technique used in sacrospinous ligament fixation for stage 3 or 4 pelvic organ prolapse. A total of 195 patients underwent surgery at a tertiary care center between January 2020 and January 2023. The primary outcome was the rate of reoperation due to recurrence within 24 months. Secondary outcomes included operative time, prolapse recurrence rate, and postoperative complications such as gluteal pain. The study was designed to evaluate whether a simplified suture method could improve surgical efficiency and patient recovery without compromising anatomical success.

Conditions

Pelvic Organ Prolapse; Surgical Procedure; Complications, Late Effect of Complications

Keywords

urogynecology; pelvic organ prolapse; sacrospinous ligament fixation; prolapse recurrence

Outcome Measures

Primary Outcomes (1)

• Reoperation rate

  Reoperation rate due to prolapse recurrence within 24 months

  24 months

Secondary Outcomes (3)

• Total operative time (in minutes)

  up to 200 minutes

• Postoperative complications (e.g. gluteal pain, hematoma)

  24 months

• Prolapse recurrence rate (Stage ≥2 on POP-Q)

  24 months

Study Arms (2)

Double Suture Technique

Double Suture Technique - classical SSF using two individual permanent sutures.

Procedure: sacrospinous ligament fixation

Loop Suture Technique

Loop Suture Technique - SSF using a single loop-style suture

Procedure: sacrospinous ligament fixation

Interventions

sacrospinous ligament fixation PROCEDURE

A longitudinal incision was made at the midline of the posterior vaginal wall, extending approximately 2-3 cm from the perineal body to the vaginal apex to form a tunnel. The incised vaginal epithelium was dissected from the underlying muscularis layer. Dissection was continued to the level of the ischial spine. The rectum was medialized to access the perirectal space. Upon palpating the ischial spine, the sacrospinous ligament was identified medial to it. Long retractors were placed over the ischial spine to protect the pudendal neurovascular structures. The bladder was retracted superiorly, and the rectum medially, for optimal visualization. Two separate or a loop 1-0 polypropylene suture(s) were placed approximately 1.5 fingerbreadths medial to the ischial spine on the ligament using a needle holder. These sutures were passed through the posterior vaginal tunnel to the apex and tied to secure the vaginal apex to the ligament

Double Suture Technique; Loop Suture Technique

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: As uterine prolapse occures only in women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 30 to 80 years with stage 3 or 4 apical pelvic organ prolapse who underwent sacrospinous ligament fixation at a tertiary urogynecology center. All patients were treated between January 2020 and January 2023.

You may qualify if:

• Stage 3 or 4 apical pelvic organ prolapse
• Underwent SSF between Jan 2020 and Jan 2023

You may not qualify if:

• Concomitant malignancy
• Previous apical prolapse surgery

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, Türkiye, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: August 6, 2025
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

TU (1)