Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-29 @ 11:41 AM
Study NCT ID:
NCT07106866
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOOP VS DOUBLE SUTURE TECHNIQUES IN SACROSPINOUS FIXATION: A TWO-YEAR STUDY
Sponsor:
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Organization:
Study Overview
Official Title:
A Comparative Evaluation of Double Versus Loop Suture Techniques in Sacrospinous Ligament Fixation Over Two Years
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: