Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID07082023

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

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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