Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Rectal Prolapse Clinical Trial

Official title:

Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02870192
• Other study ID #: 91/12
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 12, 2016
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: University of Rome Tor Vergata
• Contact: Mostafa Shalaby, MD, MSc
• Phone: 0039329353441
• Email: shalaby-mostafa[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• other condition than rectal prolapse

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-operative complications	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	30 days postoperative	Yes