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Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
perineal rectosigmoidectomy
Sponsored by
Viet Duc University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse

Eligibility Criteria

52 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 2 cases incarceration rectalprolapse

Exclusion Criteria:

  • N/A

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    incarceration rectal prolapse

    Arm Description

    Outcomes

    Primary Outcome Measures

    recurrent rectal prolapse
    patients were asked for symptoms such as: pain during bowel movements, mucus or blood discharge from the protruding tissue, a loss of urge to defecate, awareness of something protruding upon wiping

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    August 20, 2018
    Sponsor
    Viet Duc University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03643393
    Brief Title
    Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
    Official Title
    Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    June 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Viet Duc University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Incarceration and necrosis of rectal prolapse is rare and often requires urgent management. Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this condition. The need for a diverting stoma depends on the patient's condition and the experience and judgement of the surgeon. A literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Prolapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    incarceration rectal prolapse
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    perineal rectosigmoidectomy
    Other Intervention Name(s)
    Altemeier's procedure
    Intervention Description
    In an Altemeier perineal rectosigmoidectomy, a full-thickness circumferential incision is made in the prolapsed rectum about 1-2 cm from the dentate line (see the image below). The hernia sac is entered, and the prolapse is delivered. The mesentery of the prolapsed bowel is serially ligated until no further redundant bowel can be pulled down. The bowel is transected and either hand-sewn to the distal anal canal or stapled with a circular stapler. Before anastomosis, some surgeons plicate the levator ani muscles anteriorly, which may help improve continence.
    Primary Outcome Measure Information:
    Title
    recurrent rectal prolapse
    Description
    patients were asked for symptoms such as: pain during bowel movements, mucus or blood discharge from the protruding tissue, a loss of urge to defecate, awareness of something protruding upon wiping
    Time Frame
    3 months after surgery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    52 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 2 cases incarceration rectalprolapse Exclusion Criteria: N/A
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    xuan hung nguyen, DR
    Organizational Affiliation
    center of colorectal surgery - viet duc university hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure

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