Gaziosmanpasa Training and Research Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Location contact
ecenur md çelikoğlu
SUB_INVESTIGATOR
süleyman salman
CONTACT
yağmur md acıyiyen
SUB_INVESTIGATOR
NCT Number: NCT07082023
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.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Location status: Recruiting
ecenur md çelikoğlu
SUB_INVESTIGATOR
süleyman salman
CONTACT
yağmur md acıyiyen
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
Mesh-free sacrocolpopexy performed via conventional laparoscopy.
Time frame: 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.
Time frame: Baseline and 6 months postoperative
Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
ecenur çelikoğlu, md
CONTACT
yağmur acıyiyen, md
CONTACT
Havva Betül Bacak
Other Gov
Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
Acronym: vnotes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04829175
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
New Haven, Connecticut, United States
View Trial DetailsNCT04829058
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
North Wales, Pennsylvania, United States
View Trial DetailsNCT07471464
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Cleveland, Ohio, United States
View Trial DetailsNCT07517965
Pathological Conditions, Anatomical, Pathological Conditions, Signs and Symptoms
Asyut, Egypt
View Trial Details