Enhanced Recovery After Surgery In Hirschsprung Disease (ERASIHD)

May 18, 2016 updated by: Weibing Tang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The Children's Hospital Of Soochow University
        • Contact:
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group
        • Contact:
      • Xuzhou, Jiangsu, China, 210000
        • Recruiting
        • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Hirschsprung Disease

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
Patients receive the Enhanced Recovery After Surgery program during the peri-operative period.
Procedure: Enhanced Recovery After Surgery Program
optimized peri-operative protocol
Other Names:
  • Fast Track Surgery
Other: Traditional group
Patients receive the Traditional program during the peri-operative period.
Procedure: Traditional Program
traditional standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
median length of postoperative hospital day
Time Frame: 30days
30days

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative complications rates
Time Frame: within 30 days
within 30 days
gastrointestinal functional recovery time
Time Frame: within 30 days
within 30 days
mean cost per patient
Time Frame: within 30 days
within 30 days
the readmission rates
Time Frame: within 30 days
within 30 days
the level of stress and inflammation marker
Time Frame: within 30 days
within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weibing Tang

Collaborators

Xuzhou Medical University
Wuxi People's Hospital
Soochow University

Investigators

  • Study Chair: Weibing Tang, MD&PhD, Nanjing Children's Hospital Affiliated to Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 15, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WTang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hirschsprung Disease

Clinical Trials on Enhanced Recovery After Surgery Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe