Clinical Trial: Surgical Correction of Pelvic Organ Prolapse
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE
Brief Summary:
Objective:
This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical techniques, efficacy and overall results are compared.
Methods:
In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is achieved in both groups by two polypropylene meshes.
Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.
Detailed Summary:
Surgical technique In both open or laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures.
The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.
Sponsor: University Of Perugia
Current Primary Outcome: Operative morbidity and adverse events [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Subjective and objective success rate, Patient satisfaction [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: University Of Perugia
Dates:
Date Received: August 12, 2010
Date Started: August 2010
Date Completion:
Last Updated: May 19, 2014
Last Verified: July 2010