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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-NOTES Sacrocolpopexy | Experimental | Patients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES). |
|
| Laparoscopic Sacrocolpopexy | Active Comparator | Patients undergoing mesh-free sacrocolpopexy via conventional laparoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-NOTES Mesh-Free Sacrocolpopexy | Procedure | Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months postoperative |
| Change in PISQ-12 Score | Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement. | Baseline and 6 months postoperative |
| 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. | Baseline and 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ecenur çelikoğlu, md | Contact | +90 538 54 92 848 | ecenurcelikoglu14@gmail.com | |
| yağmur acıyiyen, md | Contact | +90 542 566 9593 | yagmuraciyiyen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| süleyman salman, prof | Gaziosmanpaşa Training and Research Hospital | Study Director |
| havva betül bacak, md | Gaziosmanpaşa Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziosmanpasa Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Laparoscopic Mesh-Free Sacrocolpopexy | Procedure | Mesh-free sacrocolpopexy performed via conventional laparoscopy. |
|