Enhanced Recovery After Surgery In Hirschsprung Disease (ERASIHD)

Weibing Tang

Status: Unknown

Conditions: Hirschsprung Disease

Treatments: Procedure: Enhanced Recovery After Surgery Program; Procedure: Traditional Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02776176

WTang

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Hirschsprung Disease

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ERAS group

Experimental group

Description:

Patients receive the Enhanced Recovery After Surgery program during the peri-operative period.

Treatment:

Procedure: Enhanced Recovery After Surgery Program

Traditional group

Other group

Description:

Patients receive the Traditional program during the peri-operative period.

Treatment:

Procedure: Traditional Program