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

Hirschsprung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03269812
• Other study ID #: laparoscopy in Hirschsprung
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: August 30, 2017
• Start date: September 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Mohammed Hamada Takrouney
• Phone: +201009321033
• Email: m.takrouney1988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Hirschsprung Disease

Intervention

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,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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