A Novel Approach for Apical Prolapse Surgery: Meshless Pectopexy (Salman's Modification).
Baki Erdem, Süleyman Salman, Zeynep Kübra Usta...
https://pubmed.ncbi.nlm.nih.gov/40167602Actively Recruiting
Led by Kocaeli University · Updated on 2026-02-02
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to compare two surgical methods for treating genital apical prolapse, a condition where the top of the vagina, uterus, or cervix descends. It focuses on patients who have completed their fertile period and do not want to keep their uterus. The study evaluates laparoscopic pectopexy surgery with and without the use of mesh, a material sometimes linked to complications like mesh erosion, especially in obese patients where surgery is more challenging. Participants will undergo laparoscopic pectopexy surgery after hysterectomy. One group will have the vaginal cuff attached to the pectineal ligament using a non-absorbable suture without mesh, aiming to reduce mesh-related complications. The other group will have the vaginal cuff attached using polypropylene mesh, which is the standard technique. Both surgeries use a standard laparoscopic hysterectomy approach. During the study, patients will have their prolapse stage recorded before surgery and again 12 months after surgery. Quality of life related to prolapse will be assessed using a questionnaire before and one year after the operation. The main outcome measured is the rate of prolapse recurrence 12 months after surgery. Follow-up examinations will be conducted at 12 months post-surgery to evaluate results and safety. Participation lasts at least one year from surgery to follow-up assessment.
CONDITIONS
Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo laparoscopic hysterectomy followed by laparoscopic pectopexy, either with or without mesh, to treat pelvic organ prolapse.
1 surgery visit and immediate post-operative care
Duration - 12 months after surgery
Participants are followed up to assess prolapse status and quality of life after surgery.
1 follow-up visit at 12 months post-surgery
Total: 1 location
1
Kocaeli University, School of Medicine
Köseköy, Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
Ş
Şener Gezer, M.D.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Baki Erdem, Süleyman Salman, Zeynep Kübra Usta...
https://pubmed.ncbi.nlm.nih.gov/40167602A Aleksandrov, A V Smith, B Rabischong...
https://pubmed.ncbi.nlm.nih.gov/34184848