None listed
Conditions
Brief summary
This study was undertaken to compare laparoscopic and open sacral colpopexies for efficacy and safety. This prospective randomized controlled study was conducted in the Gynecologic Department of El-Shatby Maternity Hospital , University of Alexandria in Egypt. It involved 30 women selected after fulfilling the criteria of inclusion into the study with informed consent to participate in the study. All patients in this study were randomly allocated into one of the two following groups: Group A: (15 patient) Where laparoscopic sacrocolpopexy was done. Group B :( 15 patient) Where abdominal (open) sacrocolpopexy was done. Demographic and hospital data, complications, and follow-up visits were reviewed. Median follow-up was 12 months in the laparoscopic and open groups. Mean operating time was significantly greater in the laparoscopic versus open cohort, 70 minutes and 90 minutes, respectively . Estimated blood loss (84 mL vs 156 ml) and hospital stay (2 vs 1 day ) were significantly less in the laparoscopic group than the open group. Hospital stay was was significant less in laparoscopy versus open groeup (2 versus 4 days ). Demographic data , other perioperative data, quality of life assessment , subjective , objective cure rates , complications and reoperation rates were non-significant. As a conclusion, Laparoscopic and open sacral colpopexies have comparable clinical outcomes. Although laparoscopic sacral colpopexy requires longer operating time, hospital stay and blood loss are significantly decreased. Postoperatively overall quality of life and sexual quality showed significant improvement .The subjective cure rate was 90% , the objective cure rate (no prolapse in any compartment) was 100%.
Interventions
Physical Examination: preoperative physical examination will be performed in the supine position with the Valsalva maneuver. Genital prolapse will be staged according to the pelvic organ prolapse quantification (POP-Q) as described by the International Continence Society by a gynaecologist with consistent experience.
Pre-operative Pap smear.
Preoperative urodynamic study (cystometry) .
All operations will take place under general anaesthesia in a lithotomy position with legs laid flat, with a F
Physical Examination: preoperative physical examination will be performed in the supine position with the Valsalva maneuver. Genital prolapse will be staged according to the pelvic organ prolapse quantification (POP-Q) as described by the International Continence Society by a gynaecologist with consistent experience. Pre-operative Pap smear. Preoperative urodynamic study (cystometry) . All operations will take place under general anaesthesia in a lithotomy position with legs laid flat, with a Foley catheter in the bladder. A retroperitoneal approach will be used in all cases. The posterior parietal peritoneum is incised vertically from the promontory to the vaginal apex, between the midline and the right ureter. Dissection of the peritoneal covering of the back of the cervix or the vagina. The presacral ligament is exposed in the midline over S1 by careful dissection avoiding injury to the median sacral vessels. Monofilament polypropylene mesh (Prolene) mesh will be sutured to the ligament and the vagina. Group A: (15 patient) Where laparoscopic sacrocolpopexy will be done through 4 trocar ports with average duration of 100-200 min.
Sponsors
alexandria university, faculty of medicne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Grade III or IV uterovaginal prolapse according to the pelvic organ prolapse quantification (POP-Q). 2. Uterine or vault prolapse . 3. Normal uterus and ovaries on ultrasound examination. 4. Normal menstrual bleeding pattern (if premenopausal). 5. Normal Pap smear.
Exclusion criteria
1. Inability to give informed consent or to return for follows up. 2. Unable to undergo general anaesthesia. 3. Prior sacral colpopexy. 4. Patients presenting with lower grade prolapse. 5. Genuine stress incontinence. 6. Indication for hysterectomy
Outcome results
None listed