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

August 30, 2017 updated by: Mohammed Hamada Takrouney, Assiut University

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

To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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].

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from one to three months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laparoscopy in Hirschsprung

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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