NCT02870192

Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Rectal Prolapse

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic ventral mesh rectopexy	Laparoscopic opening of the Daglous pouch, dissection till reach the levator ani muscle, mesh implementation and fixation, closure of the daglous. The mesh implemented may be synthetic or biological mesh.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-01
• Completion: 2018-01-01
• First posted: 2016-08-17
• Last updated: 2016-08-17