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

Z

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status

Completed

Conditions

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

Treatments

Procedure: sacrospinous ligament fixation

Study type

Observational

Funder types

Other

Identifiers

NCT07106866
SSFtecnique

Details and patient eligibility

About

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.

Full description

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.

Enrollment

195 patients

Sex

Female

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

195 participants in 2 patient groups

Double Suture Technique
Description:
Double Suture Technique - classical SSF using two individual permanent sutures.
Treatment:
Procedure: sacrospinous ligament fixation
Loop Suture Technique
Description:
Loop Suture Technique - SSF using a single loop-style suture
Treatment:
Procedure: sacrospinous ligament fixation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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