Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02870192
• Collaborator: (none)
• Enrollment: 200
• Arm: 1
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Procedure: Laparoscopic ventral mesh rectopexy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rectal Prolapse Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.	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.

Outcome Measures

Primary Outcome Measures

1. intra-operative complications [30 days postoperative]

   All complications occur during the operation and discovered and managed during the operation or passed undiscovered and discovered postoperative during the same admission or require readmission

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse

Exclusion Criteria:

• other condition than rectal prolapse

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

• Principal Investigator: Pierpaolo Sileri, MD, PhD, University of Rome Tor Vergata

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pierpaolo Sileri, Prof, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT02870192
• Other Study ID Numbers: 91/12
• First Posted: Aug 17, 2016
• Last Update Posted: Aug 17, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Pierpaolo Sileri, Prof, University of Rome Tor Vergata: Rectal Prolapse
• Additional relevant MeSH terms: Rectal Prolapse; Prolapse

Study Results

No Results Posted as of Aug 17, 2016