NCT02776176

Enhanced Recovery After Surgery In Hirschsprung Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Weibing Tang · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hirschsprung Disease

Interventions

Type	Name	Description
PROCEDURE	Enhanced Recovery After Surgery Program	optimized peri-operative protocol
PROCEDURE	Traditional Program	traditional standard protocol

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-05-18
• Last updated: 2016-05-19

Locations

3 sites across 1 country: China