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Completed

NCT Number: NCT07106866

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Surgical Procedure; Complications, Late Effect of Complications

Age range

30 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Istanbul, Türkiye, 34668, Turkey (Türkiye)

About this study

Sacrospinous ligament fixation is a commonly used surgical procedure for apical pelvic organ prolapse, particularly in women with advanced-stage prolapse who desire a native tissue repair approach. With increasing concerns regarding mesh-related complications, sacrospinous fixation has regained popularity as a mesh-free alternative.

This retrospective cohort study was conducted to evaluate and compare the clinical performance of two different suture techniques: the classical double suture method and a modified loop suture method. The main objective was to assess whether the loop suture technique, which involves a single point of tension, offers advantages in terms of operative efficiency and patient outcomes.

A total of 195 patients with stage 3 or 4 pelvic organ prolapse underwent sacrospinous ligament fixation between January 2020 and January 2023 at a tertiary urogynecology center. One group received the standard double suture technique, while the other underwent fixation using a single loop suture. All surgeries were performed by the same experienced surgical team.

The primary outcome was reoperation rate due to recurrence within 24 months. Secondary outcomes included total operative time, recurrence rate (as defined by POP-Q stage ≥2), and postoperative complications such as gluteal pain and rectal injury.

This study aims to provide evidence on whether a technical modification in a widely accepted native tissue repair procedure can improve surgical safety and reduce long-term complication rates.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Concomitant malignancy
  • Previous apical prolapse surgery

Treatment and study plan

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

Primary outcomes

  1. Reoperation rate

    Time frame: 24 months

    Reoperation rate due to prolapse recurrence within 24 months

Secondary outcomes

  1. Total operative time (in minutes)

    Time frame: up to 200 minutes

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

    Time frame: 24 months

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

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

A Comparative Evaluation of Double Versus Loop Suture Techniques in Sacrospinous Ligament Fixation Over Two Years

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 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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