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

Official title

Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy

Overview

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.

Detailed description

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.

Interventions

• Procedure V-NOTES Mesh-Free Sacrocolpopexy
  Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
• Procedure Laparoscopic Mesh-Free Sacrocolpopexy
  Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Primary outcome measures

• Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months [Time frame: Baseline and 6 months postoperative]
• Change in PISQ-12 Score [Time frame: Baseline and 6 months postoperative]
• Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score [Time frame: Baseline and 6 months postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gaziosmanpasa Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07082023 · gopvnotessacrocolpopexy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗