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
About this trial
This is an interventional treatment trial for Hirschsprung Disease
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
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
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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