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

NCT ID: NCT03269812

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-10-01

Brief Summary

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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

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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\[4,5\].

Conditions

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Hirschsprung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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,

Group Type EXPERIMENTAL

laparoscopic assisted pull-through oeration

Intervention Type PROCEDURE

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,

non laparoscopic operated group

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

Group Type EXPERIMENTAL

laparoscopic assisted pull-through oeration

Intervention Type PROCEDURE

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,

Interventions

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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,

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hamada Takrouney

Principal investigator and Assistant lecturer of pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammed Hamada Takrouney

Role: CONTACT

+201009321033

Ibrahim Ali Ibrahim

Role: CONTACT

+201005801291

References

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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.

Reference Type BACKGROUND
PMID: 27369964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28058486 (View on PubMed)

Other Identifiers

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laparoscopy in Hirschsprung

Identifier Type: -

Identifier Source: org_study_id

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