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Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease

Primary Purpose

Hirschsprung Disease

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

About this trial

This is an interventional treatment trial for Hirschsprung Disease

Eligibility Criteria

6 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from 6months to 3 years.
  2. Both sexes.
  3. Classic and long segment Hirshsprung.
  4. Total a ganglionic colon.
  5. Hirshsprung disease with leveling colostomy

Exclusion Criteria:

  1. Patients <6 months and >3 years.
  2. Short and Ultra-short Hirshsprung.
  3. Recurrent cases of Hirshsprung.
  4. Other contraindication of laparoscopy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    laparoscopic operated group

    non laparoscopic operated group

    Arm Description

    Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,

    Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.

    Outcomes

    Primary Outcome Measures

    Constipation
    persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2017
    Last Updated
    August 30, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03269812
    Brief Title
    Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease
    Official Title
    Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    September 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (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
    To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.
    Detailed Description
    Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity[4,5].

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic operated group
    Arm Type
    Experimental
    Arm Description
    Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
    Arm Title
    non laparoscopic operated group
    Arm Type
    Experimental
    Arm Description
    Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic assisted pull-through oeration
    Intervention Description
    Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
    Primary Outcome Measure Information:
    Title
    Constipation
    Description
    persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.
    Time Frame
    from one to three months after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age from 6months to 3 years. Both sexes. Classic and long segment Hirshsprung. Total a ganglionic colon. Hirshsprung disease with leveling colostomy Exclusion Criteria: Patients <6 months and >3 years. Short and Ultra-short Hirshsprung. Recurrent cases of Hirshsprung. Other contraindication of laparoscopy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Hamada Takrouney
    Phone
    +201009321033
    Email
    m.takrouney1988@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ibrahim Ali Ibrahim
    Phone
    +201005801291
    Email
    Dr.ibrahimali@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27369964
    Citation
    Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.
    Results Reference
    background
    PubMed Identifier
    28058486
    Citation
    Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.
    Results Reference
    background

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    Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease

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