A Trial on Treatments of Hirschsprung Allied Disease

Not Applicable

Recruiting

• Conditions: Complications of Treatment; Complication of Surgical Procedure; Megacolon, Not Hirschsprung
• Interventions: Behavioral: conservative; Procedure: operative

• Registration Number: NCT02212054
• Lead Sponsor: Tongji Hospital

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Study Start: 2020-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative & operative treatment	conservative	anal dilation; colon lavage; probiotics
operative treatment	operative	one stage pull- through radical colectomy

Primary Outcome Measures

Name	Time	Method
the change of defecation frequency	6~12 months	the changes of defecation frequency at 6\~12 months after treatment

Secondary Outcome Measures

Name	Time	Method
complications	6~12 months	complications were suffered by patients or not
stool pattern	6~12 months	stool pattern as hard stool or loose stool
controlling stool ability	6~12 months	whether patients' controlling stool ability is better or not after treatment

Trial Locations

Locations (1)

Department of Pediatric Surgery; 🇨🇳 Wuhan, Hubei, China