Enhanced Recovery After Surgery In Hirschsprung Disease

Study Overview
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Brief Summary
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The study is designed to determine if enhanced recovery after surgery (ERAS) principles could provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease (HD). Half of patients will receive the ERAS program, while the other half will receive the traditional program.

Detailed Description
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Optimized peri-operative care within an enhanced recovery after surgery (ERAS) protocol is designed to reduce morbidity after surgery, resulting in a shorter hospital stay. The present study evaluated this approach in the context of radical surgery for pediatric patients with Hirschsprung's Disease(HD). Patients undergoing radical surgery for HD will be enrolled in a randomized clinical trial comparing ERAS protocol vs a control group that received standard care. The primary outcome is median length of postoperative hospital stay. The second outcomes include postoperative complications rates，gastrointestinal function recovery time，mean cost per patient，readmission rates within postoperative 30 days，and the levels of stress and inflammation marker.

Official Title
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A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.

Conditions
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Hirschsprung Disease

Intervention / Treatment
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* Procedure: Enhanced Recovery After Surgery Program
* Procedure: Traditional Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Hirschsprung Disease Exclusion Criteria: with other disease receive emergency surgery need to do the ostomy full colonic Hirschsprung Disease

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Patients receive the Enhanced Recovery After Surgery program during the peri-operative period. | Procedure: Enhanced Recovery After Surgery Program<br>* optimized peri-operative protocol<br>* Other names: Fast Track Surgery;|
| Other: Traditional group<br>Patients receive the Traditional program during the peri-operative period. | Procedure: Traditional Program<br>* traditional standard protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median length of postoperative hospital day |  | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications rates |  | within 30 days | 
| gastrointestinal functional recovery time |  | within 30 days | 
| mean cost per patient |  | within 30 days | 
| the readmission rates |  | within 30 days | 
| the level of stress and inflammation marker |  | within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery, hirschsprung disease