Clinical Trial: Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Brief Summary: Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.
Detailed Summary: Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.
Sponsor: University of Rome Tor Vergata
Current Primary Outcome: intra-operative complications [ Time Frame: 30 days postoperative ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Rome Tor Vergata
Dates:
Date Received: August 9, 2016
Date Started: January 2017
Date Completion: January 2018
Last Updated: August 12, 2016
Last Verified: August 2016