A Trial on Treatments of Hirschsprung Allied Disease

Complication of Surgical Procedure Clinical Trial

Official title:

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02212054
• Other study ID #: 101
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Xiong J Feng, MD,PhD
• Phone: 0086-27-83665309
• Email: 31699788[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Description:

The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• hard or firm stools for twice or less per week

• a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Exclusion Criteria:

• functional constipation

• a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Complications of Treatment
• Megacolon
• Megacolon, Not Hirschsprung

Intervention

Behavioral:
• conservative
anal dilatation; colonic lavage; oral probiotic

Procedure:
• operative
one stage pull through radical colectomy

Locations

Country	Name	City	State
China	Department of Pediatric Surgery	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of defecation frequency	the changes of defecation frequency at 6~12 months after treatment	6~12 months
Secondary	stool pattern	stool pattern as hard stool or loose stool	6~12 months
Secondary	controlling stool ability	whether patients' controlling stool ability is better or not after treatment	6~12 months
Secondary	complications	complications were suffered by patients or not	6~12 months