Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedSeptember 1, 2017
August 1, 2017
2 years
August 29, 2017
August 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
from one to three months after operation
Study Arms (2)
laparoscopic operated group
EXPERIMENTALUnder 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,
non laparoscopic operated group
EXPERIMENTALUnder general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.
Interventions
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,
Eligibility Criteria
You may qualify if:
- Age from 6months to 3 years.
- Both sexes.
- Classic and long segment Hirshsprung.
- Total a ganglionic colon.
- Hirshsprung disease with leveling colostomy
You may not qualify if:
- Patients \<6 months and \>3 years.
- Short and Ultra-short Hirshsprung.
- Recurrent cases of Hirshsprung.
- Other contraindication of laparoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 27369964BACKGROUNDTaguchi 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.
PMID: 28058486BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator and Assistant lecturer of pediatric surgery
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 1, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
September 1, 2017
Record last verified: 2017-08