Actively Recruiting
Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
Led by Havva Betül Bacak · Updated on 2025-07-24
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pelvic organ prolapse (POP) is a common condition affecting women, especially as they age and have had children, often requiring surgery. This research is evaluating and comparing two minimally invasive surgical methods for repairing POP without using synthetic mesh: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. The study aims to see if the V-NOTES technique offers similar or better surgical outcomes, safety, and patient satisfaction compared to the traditional laparoscopic approach. The two treatments being studied are mesh-free sacrocolpopexy performed through V-NOTES and through conventional laparoscopy. Both procedures are done by experienced surgeons. The study will analyze factors like operation time, complications during and after surgery, hospital stay length, pain levels, anatomical repair success, and patient satisfaction. Participants will be randomly assigned to one of these two surgical methods. Participants will be assessed before surgery and then followed up for at least six months after the procedure. Researchers will measure changes in the Pelvic Organ Prolapse Quantification (POP-Q) stage, sexual function using the PISQ-12 score, and pelvic floor distress with the PFDI-20 score from baseline to six months post-surgery. Safety, anatomical and functional outcomes, and patient satisfaction will be closely monitored throughout the study duration, which is expected to last until January 2026.
CONDITIONS
Brief Title
Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients over 18 years old
- Diagnosed with symptomatic pelvic organ prolapse with apical and anterior POP-Q stage 2 or higher
- Undergoing surgery by experienced surgeons
- Patients who applied to the specified gynecology and obstetrics clinic for prolapse surgery
You will not qualify if you...
- Previous chemotherapy or radiation therapy for any cancer
- Previous surgery for pelvic organ prolapse
- Severe cardiovascular or respiratory disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery and immediate recovery period
Participants undergo mesh-free sacrocolpopexy surgery either via vaginal natural orifice transluminal endoscopic surgery (V-NOTES) or conventional laparoscopy.
1 surgical procedure with hospital stay for postoperative care
Duration - 6 months postoperative
Participants return for postoperative assessments to evaluate recovery, complications, and surgical outcomes.
Visits at baseline and 6 months postoperative
Trial Site Locations
Total: 1 location
1
Gaziosmanpasa Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
E
ecenur çelikoğlu, md
Y
yağmur acıyiyen, md
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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