Enhanced Recovery After Surgery In Hirschsprung Disease

Not Applicable

• Conditions: Hirschsprung Disease
• Interventions: Procedure: Traditional Program; Procedure: Enhanced Recovery After Surgery Program

• Registration Number: NCT02776176
• Lead Sponsor: Weibing Tang

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinical diagnosis of Hirschsprung Disease

Exclusion Criteria

• with other disease
• receive emergency surgery
• need to do the ostomy
• full colonic Hirschsprung Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional group	Traditional Program	Patients receive the Traditional program during the peri-operative period.
ERAS group	Enhanced Recovery After Surgery Program	Patients receive the Enhanced Recovery After Surgery program during the peri-operative period.

Primary Outcome Measures

Name	Time	Method
median length of postoperative hospital day	30days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College; 🇨🇳 Xuzhou, Jiangsu, China

Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group; 🇨🇳 Wuxi, Jiangsu, China

The Children's Hospital Of Soochow University; 🇨🇳 Suzhou, Jiangsu, China