Actively Recruiting
Comparison of Early Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
Led by Gaziosmanpasa Research and Education Hospital · Updated on 2025-01-31
84
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on comparing early postoperative outcomes in female patients with stage 3 or 4 pelvic organ prolapse. It evaluates two surgical approaches: laparoscopic lateral suspension and V-NOTES lateral suspension using the Salman Ketenci Gencer technique. The study is observational and sponsored by Gaziosmanpasa Research and Education Hospital to understand how these methods impact pelvic organ prolapse severity. The study involves two groups of patients: those who have undergone laparoscopic lateral suspension and those treated with the V-NOTES lateral suspension using the Salman Ketenci Gencer technique. Both procedures aim to address pelvic organ prolapse, and the research compares their effectiveness by assessing postoperative improvements. Participants will be monitored for changes in pelvic organ prolapse severity using the POP-Q score at six months after surgery. The study tracks early postoperative outcomes to evaluate improvement levels. Female patients aged 18 to 75 years will be included, and the study excludes those with certain cervical pathologies, infections, or pregnancy. Participation involves follow-up assessments to measure surgical results and safety.
CONDITIONS
Brief Title
Comparison of Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage 3 or 4 pelvic organ prolapse
- Sexually active female patients
- Age between 18 and 75 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo laparoscopic lateral suspension or V-NOTES lateral suspension with the Salman Ketenci Gencer technique and receive immediate post-operative care.
1 surgical visit and several immediate post-operative assessments
Duration - 6 months
Participants are followed to assess postoperative improvement in pelvic organ prolapse severity and recovery.
Approximately 3 to 4 follow-up visits
Trial Site Locations
Total: 1 location
1
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Fatma Ketenci Gencer, Associate Professor
H
Havva Betül Bacak, Specialist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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