Comparison of Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique

NCT06802497 | Recruiting DMC

• 1 other identifier: GaziosmanpasaTREHfkg
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique

Conditions

Pelvic Organ Prolapse

Keywords

laparoscopy; v-notes lateral suspension; pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• Postoperative Improvement in Pelvic Organ Prolapse (POP) Severity by POP-Q Score

  POP-Q measurements assess the degree of pelvic organ prolapse in patients, using a combined system that includes multiple parameters to evaluate the anterior and posterior vaginal walls, cervix, and vaginal vault. This study will compare the POP-Q values of patients following laparoscopic lateral suspension and V-Notes lateral suspension with the Salmanketencigencer technique to assess improvements in prolapse severity.

  6 months

Study Arms (2)

patients underwent laparoscopic lateral suspension

patients underwent V-NOTES lateral suspension with SalmanKetenciGencer technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study planned to include 84 patients with pelvic organ prolapse.

You may qualify if:

• Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients

You may not qualify if:

• Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma Ketenci Gencer, Associate Professor

CONTACT

+905416116469; fathma_k@hotmail.com

Havva Betül Bacak, Specialist

CONTACT

+905333610088; hbbacak90@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 31, 2025
• Study Start: July 12, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-07

Locations

TU (1)