Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Primary Purpose
Rectal Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic ventral mesh rectopexy
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Prolapse focused on measuring Rectal Prolapse
Eligibility Criteria
Inclusion Criteria:
- all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse
Exclusion Criteria:
- other condition than rectal prolapse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rectal Prolapse
Arm Description
Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02870192
First Posted
August 9, 2016
Last Updated
August 12, 2016
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT02870192
Brief Title
Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Official Title
Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
Rectal Prolapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rectal Prolapse
Arm Type
Experimental
Arm Description
Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral mesh rectopexy
Intervention Description
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.
Primary Outcome Measure Information:
Title
intra-operative complications
Description
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
Time Frame
30 days postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse
Exclusion Criteria:
other condition than rectal prolapse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Shalaby, MD, MSc
Phone
0039329353441
Email
shalaby-mostafa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pierpaolo Sileri, MD, PhD
Email
piersileri@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Sileri, MD, PhD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
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