Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-01

Brief Summary

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This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. By evaluating perioperative data, complication rates, anatomical and functional outcomes, this trial seeks to determine whether the V-NOTES approach provides comparable or superior results to the traditional laparoscopic technique, without the use of synthetic mesh.

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Detailed Description

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Pelvic organ prolapse (POP) is a common condition among women, especially with increasing age and parity, often requiring surgical intervention. Sacrocolpopexy is considered the gold standard for apical prolapse repair due to its high anatomical success rate and long-term durability. Traditionally performed via open or laparoscopic approaches, sacrocolpopexy has evolved with minimally invasive techniques.

Recently, mesh-related complications have led to a growing interest in mesh-free alternatives. Simultaneously, natural orifice approaches such as Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) have gained popularity due to better cosmetic results, reduced postoperative pain, and faster recovery times.

This prospective, comparative study aims to evaluate and compare the clinical outcomes of mesh-free sacrocolpopexy performed via V-NOTES versus the laparoscopic approach. Parameters including operative time, intraoperative and postoperative complications, hospital stay, pain scores, anatomical success, and patient satisfaction will be analyzed. The goal is to assess whether V-NOTES can be a safe and effective alternative to laparoscopic mesh-free sacrocolpopexy in the surgical management of POP.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, interventional, randomized, parallel-group clinical trial comparing two minimally invasive surgical techniques for pelvic organ prolapse repair: V-NOTES sacrocolpopexy and laparoscopic sacrocolpopexy, both performed without synthetic mesh. Participants will be randomly assigned (1:1) to either group. The study aims to evaluate outcomes using validated tools including POP-Q, PFDI-20, and PISQ-12 over a 6-month follow-up period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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V-NOTES Sacrocolpopexy

Patients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

Group Type EXPERIMENTAL

V-NOTES Mesh-Free Sacrocolpopexy

Intervention Type PROCEDURE

Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

Laparoscopic Sacrocolpopexy

Patients undergoing mesh-free sacrocolpopexy via conventional laparoscopy.

Group Type ACTIVE_COMPARATOR

Laparoscopic Mesh-Free Sacrocolpopexy

Intervention Type PROCEDURE

Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Interventions

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V-NOTES Mesh-Free Sacrocolpopexy

Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

Intervention Type PROCEDURE

Laparoscopic Mesh-Free Sacrocolpopexy

Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who applied to Gaziosmanpaşa Education and Research Hospital, Gynecology and Obstetrics Clinic, who underwent surgery due to symptomatic pelvic organ prolapse with apical and anterior POP Q stage 2 and above, Being over 18 years old Patients who underwent surgery by experienced surgeons

Exclusion Criteria

* Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to proplasus Patients with severe cardiovascular or respiratory disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No