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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
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Prolapse focused on measuring Rectal Prolapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 9, 2016
    Last Updated
    August 12, 2016
    Sponsor
    University of Rome Tor Vergata
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    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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