Health TrialsbyHealthPanel

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

ConditionPelvic Organ Prolapse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHavva Betül Bacak

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • V-NOTES Mesh-Free Sacrocolpopexy

    Procedure/Surgery

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

  • Laparoscopic Mesh-Free Sacrocolpopexy

    Procedure/Surgery

    Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: V-NOTES SacrocolpopexyExperimental treatment 1 intervention
Group B: Laparoscopic SacrocolpopexyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months

Anatomical success will be evaluated using the POP-Q system. A reduction of prolapse stage by at least one level or achieving stage 0-1 will be considered successful.

Time frame
Baseline and 6 months postoperative
2

Change in PISQ-12 Score

Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.

Time frame
Baseline and 6 months postoperative
3

Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score

Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms.

Time frame
Baseline and 6 months postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Havva Betül Bacak

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Sponsor institution

Source ClinicalTrials.gov
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