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

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ClinicalTrials.gov Identifier: NCT03269812
Recruitment Status : Unknown
Verified August 2017 by Mohammed Hamada Takrouney, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Hamada Takrouney, Assiut University

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.

Condition or disease Intervention/treatment Phase
Hirschsprung Disease Procedure: laparoscopic assisted pull-through oeration Not Applicable

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].

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2019


Arm Intervention/treatment
Experimental: laparoscopic operated group
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,
Procedure: laparoscopic assisted pull-through oeration
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,

Experimental: non laparoscopic operated group
Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.
Procedure: laparoscopic assisted pull-through oeration
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 Measures :
  1. Constipation [ Time Frame: from one to three months after operation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269812


Contacts
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Contact: Mohammed Hamada Takrouney +201009321033 m.takrouney1988@gmail.com
Contact: Ibrahim Ali Ibrahim +201005801291 Dr.ibrahimali@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Mohammed Hamada Takrouney, Principal investigator and Assistant lecturer of pediatric surgery, Assiut University
ClinicalTrials.gov Identifier: NCT03269812    
Other Study ID Numbers: laparoscopy in Hirschsprung
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs