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Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

Primary Purpose

Anorectal Malformation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic pull-through
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Anorectal Malformation

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done

Exclusion Criteria:

  • all cases with low anomalies will be excluded.
  • Female child with vestibular anus
  • case with short distal pouch

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    laparoscopic group

    posterior sagittal group

    Arm Description

    laparoscopic pull-through

    posterior sagittal anorectoplasty

    Outcomes

    Primary Outcome Measures

    stool continence
    questionaire about the degree of stool continence

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2017
    Last Updated
    June 10, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03174028
    Brief Title
    Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty
    Official Title
    Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2017 (Anticipated)
    Primary Completion Date
    August 1, 2019 (Anticipated)
    Study Completion Date
    January 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Anorectal malformations are congenital malformations, in which the terminal part of the hindgut is abnormally placed and lies outside (partially or completely) the sphincter mechanism.
    Detailed Description
    The incidence of anorectal malformation ~1 in 5,000 More common in Down's syndrome and Cat-eye syndrome. Male >female (60:40).It is classified into many types according to the degree of descent of the rectal pouch in the pelvis, the fistula between the rectum and the urinary system in males and genital system in females. The most common type in males is high anorectal malformation with rectourethral fistula There are many historical operations for the management of the high type, but the most popular operation now is the posterior sagittal anorectoplasty which was published for the first time in 1982. Children undergoing posterior sagittal anorectoplasty may have lifelong bowel management problems of constipation, incontinence, and encopresis. After the introduction of laparoscopy in pediatric surgery, many surgeons hope that the use of laparoscopy instead of posterior sagittal anorectoplasty may reduce the complications of the complications of the big incision and disturbance of sphincter mechanism which occur in posterior sagittal anorectoplasty operation. In addition to its role in diagnosis in complex anomalies like cloaca which is well established now. So the question is to what extent can the laparoscopy replace usual surgery for anorectal malformation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorectal Malformation

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic group
    Arm Type
    Active Comparator
    Arm Description
    laparoscopic pull-through
    Arm Title
    posterior sagittal group
    Arm Type
    Sham Comparator
    Arm Description
    posterior sagittal anorectoplasty
    Intervention Type
    Device
    Intervention Name(s)
    laparoscopic pull-through
    Intervention Description
    laparoscopic pull-through
    Primary Outcome Measure Information:
    Title
    stool continence
    Description
    questionaire about the degree of stool continence
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done Exclusion Criteria: all cases with low anomalies will be excluded. Female child with vestibular anus case with short distal pouch

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty

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