Comparing treatments for constipation in children with Hirschsprung allied disease
A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
NA · Tongji Hospital · NCT02212054
This study is testing whether non-surgical treatments or surgery work better to help children with Hirschsprung allied disease manage their constipation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT02212054 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of conservative treatments, such as anal dilatation and colonic lavage, versus operative treatments for alleviating constipation symptoms in children diagnosed with Hirschsprung allied disease. The research will involve assessing the frequency and consistency of bowel movements in participants receiving either treatment approach. By comparing these two methods, the study seeks to determine which is more beneficial for improving the quality of life in affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children experiencing hard or firm stools twice or less per week and who have a predicting score of less than 5.
Not a fit: Patients with functional constipation or a predicting score of more than 5 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for managing constipation in children with Hirschsprung allied disease.
How similar studies have performed: While there may be limited data on similar studies, the comparative approach of conservative versus operative treatments in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wuhan, Hubei
- Department of Pediatric Surgery — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Principal investigator: Qi T Zhu, PhD — department of pediatric surgery
- Study coordinator: Xiong J Feng, MD,PhD
- Email: 31699788@qq.com
- Phone: 0086-27-83665309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Complications of Treatment, Complication of Surgical Procedure, Megacolon, Not Hirschsprung