Kocaeli University, School of Medicine
Köseköy, Kocaeli, 41380, Turkey (Türkiye)
Location status: Recruiting
Recruiting
NCT Number: NCT07306715
Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support. Laparoscopic pectopexy is a surgical method developed as an alternative to the gold standard, sacrocolpopexy, in the treatment of genital organ prolapse, especially for obese patients for whom dissection is difficult. The vaginal cuff is attached to the pectineal ligament with polypropylene mesh in the standard technique. The use of mesh is subject to serious restrictions due to complications such as mesh erosion. Surgical methods without using a mesh may be safer treatment options for patients with genital prolapse. This study aimed to compare the results of Laparoscopic Pectopexy surgery with and without the use of mesh material after hysterectomy.
Recruiting
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Conditions
Age range
40 year–80 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
After ethics committee approval, patients with stage 2 and above pelvic organ prolapse according to the POP-Q staging system, who have completed their fertile period and do not want uterus preservation, will be included in the study. The stage of prolapse according to POP-Q and other gynecological examination findings will be recorded at the initial examination. Prolapse and its impact on the quality of life will be recorded preoperatively and 12 months postoperatively with the Prolapse Quality of Life Questionnaire (P-QOL). Patients will be called for examination 12 months after the operation. The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system is the main outcome of the study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Female patients older than 40 years and younger than 80 years old with symptomatic uterine prolapse
- Patients who provided written consent for the surgical procedure
- Patients who do not wish to preserve their uterus
Exclusion criteria
- Patients who cannot obtain anesthesia approval for laparoscopic surgery
- Patients who have a confirmed or suspected pregnancy
- Patients who have abnormal uterine/cervical/vaginal bleeding
- Patients with biopsy-confirmed endometrial hyperplasia or cervical dysplasia
- Patients with pathology-confirmed genital cancer
- Patients undergone chemotherapy or radiotherapy for any type of cancer
Treatment and study plan
Meshless Laparoscopic Pectopexy
ProcedureThe vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
Laparoscopic Pectopexy with mesh
ProcedureThe vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.
Primary outcomes
-
Apical descensus relapse rate
Time frame: 12 months after surgery
The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
Secondary outcomes
-
Prolapse Quality of Life (P-QOL)
Time frame: Preoperative day and 12 months after surgery
The questionnaire has nine items, each of which has a 4-point scoring system and a total score of 0-100. A high total score indicates worsening of the quality of life of women with pelvic organ prolapse.
Other outcomes
-
De novo central or lateral defect cystocele rate
Time frame: 12 months after surgery
The ratio of women with stage 2 or greater central or lateral defect cystocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system
-
De novo rectocele rate
Time frame: 12 months after surgery
The ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Kocaeli University
Other
Registry information
Official study title
Comparison of Pectopexy Operations With and Without Mesh Use After Laparoscopic Hysterectomy for Pelvic Organ Prolapse.
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 29, 2025
- Registry last updated
- Feb 2, 2026
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.
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