A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hirschsprung Disease
- Sponsor
- Weibing Tang
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- median length of postoperative hospital day
- Last Updated
- 9 years ago
Overview
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.
Investigators
Weibing Tang
Dr. Weibing Tang
Nanjing Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of Hirschsprung Disease
Exclusion Criteria
- •with other disease
- •receive emergency surgery
- •need to do the ostomy
- •full colonic Hirschsprung Disease
Outcomes
Primary Outcomes
median length of postoperative hospital day
Time Frame: 30days
Secondary Outcomes
- 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)