Genital Prolapse
Conditions
Keywords
pectopexy, mesh
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMeshless Laparoscopic Pectopexy
The vaginal cuff will be fixed to the pectineal ligament with No. 1, non-absorbable Prolene suture.
PROCEDURELaparoscopic Pectopexy with mesh
The vaginal cuff will be fixed to the pectineal ligament with polypropylene mesh.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apical descensus relapse rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Prolapse Quality of Life (P-QOL) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTŞener Gezer, M.D.
STUDY_CHAIRİsmail Bıyık, M.D.
Kütahya Sağlık Bilimleri University
Outcome results
None listed