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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02776176
Acronym
ERASIHD
Enrollment
200
Registered
2016-05-18
Start date
2016-01-31
Completion date
2019-12-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hirschsprung Disease

Keywords

enhanced recovery after surgery, hirschsprung disease

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.

Interventions

optimized peri-operative protocol

traditional standard protocol

Sponsors

Xuzhou Medical University
CollaboratorOTHER
Soochow University
CollaboratorOTHER
Wuxi People's Hospital
CollaboratorOTHER
Weibing Tang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of Hirschsprung Disease

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
median length of postoperative hospital day30days

Secondary

MeasureTime frame
postoperative complications rateswithin 30 days
gastrointestinal functional recovery timewithin 30 days
mean cost per patientwithin 30 days
the readmission rateswithin 30 days
the level of stress and inflammation markerwithin 30 days

Countries

China

Contacts

Primary ContactWeibing Tang, MD&PhD
twbcn@njmu.edu.cn+86 13851683700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026