Clinical trial NCT02776176: Enhanced Recovery After Surgery In Hirschsprung Disease
Official title: A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hirschsprung Disease
Keywords: enhanced recovery after surgery
hirschsprung disease
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Xuzhou Medical University
name: Soochow University
name: Wuxi People's Hospital
First posted: 2016-05-18
Enrollment: 200
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: median length of postoperative hospital day
timeFrame: 30days
Secondary outcomes:
measure: postoperative complications rates
timeFrame: within 30 days
measure: gastrointestinal functional recovery time
timeFrame: within 30 days
measure: mean cost per patient
timeFrame: within 30 days
measure: the readmission rates
timeFrame: within 30 days
measure: the level of stress and inflammation marker
timeFrame: within 30 days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Children's Hospital Of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
state: Jiangsu
Study officials:
affiliation: Nanjing Children's Hospital Affiliated to Nanjing Medical University
name: Weibing Tang, MD&PhD
role: STUDY_CHAIR
References:
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