Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.
ConditionGenital Prolapse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorKocaeli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Meshless Laparoscopic Pectopexy
Procedure/SurgeryThe vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
Laparoscopic Pectopexy with mesh
Procedure/SurgeryThe vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic Pectopexy without meshExperimental treatment 1 intervention
Group B: Laparoscopic Pectopexy with meshActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Apical descensus relapse rate
The ratio of women with stage 2 or greater vaginal cuff prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
Time frame
12 months after surgerySecondary outcomes
1
Prolapse Quality of Life (P-QOL)
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.
Time frame
Preoperative day and 12 months after surgeryOther outcomes
1
De novo central or lateral defect cystocele rate
The ratio of women with stage 2 or greater central or lateral defect cystocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system
Time frame
12 months after surgery2
De novo rectocele rate
The ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system
Time frame
12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov