Pelvic Organ Prolapse
Conditions
Keywords
Sacrocolpopexy, vNOTES
Brief summary
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
PROCEDUREV-NOTES Mesh-Free Sacrocolpopexy
Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
PROCEDURELaparoscopic Mesh-Free Sacrocolpopexy
Mesh-free sacrocolpopexy performed via conventional laparoscopy.
Sponsors
Havva Betül Bacak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months | Baseline and 6 months postoperative | 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. |
| Change in PISQ-12 Score | Baseline and 6 months postoperative | Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement. |
| Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score | Baseline and 6 months postoperative | Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactecenur çelikoğlu, md
Backup Contactyağmur acıyiyen, md
Outcome results
None listed