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Enhanced Recovery After Surgery In Hirschsprung Disease (ERASIHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776176
Recruitment Status : Unknown
Verified May 2016 by Weibing Tang, Nanjing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborators:
Xuzhou Medical University
Soochow University
Wuxi People's Hospital
Information provided by (Responsible Party):
Weibing Tang, Nanjing Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Hirschsprung Disease Procedure: Enhanced Recovery After Surgery Program Procedure: Traditional Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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 Name: Fast Track Surgery

Traditional group
Patients receive the Traditional program during the peri-operative period.
Procedure: Traditional Program
traditional standard protocol




Primary Outcome Measures :
  1. median length of postoperative hospital day [ Time Frame: 30days ]

Secondary Outcome Measures :
  1. postoperative complications rates [ Time Frame: within 30 days ]
  2. gastrointestinal functional recovery time [ Time Frame: within 30 days ]
  3. mean cost per patient [ Time Frame: within 30 days ]
  4. the readmission rates [ Time Frame: within 30 days ]
  5. the level of stress and inflammation marker [ Time Frame: within 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776176


Contacts
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Contact: Weibing Tang, MD&PhD +86 13851683700 twbcn@njmu.edu.cn

Locations
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China, Jiangsu
The Children's Hospital Of Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Shungen Huang, MD    +86 13776088680    drhuang01@163.com   
Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group Recruiting
Wuxi, Jiangsu, China, 214000
Contact: Yingzuo Shi, Master    +86 13861800138    shiyz@wuxiph.com   
Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College Recruiting
Xuzhou, Jiangsu, China, 210000
Contact: Hongwei Zhang, bachelor    +86 18952173385    pingweizz@163.com   
Sponsors and Collaborators
Weibing Tang
Xuzhou Medical University
Soochow University
Wuxi People's Hospital
Investigators
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Study Chair: Weibing Tang, MD&PhD Nanjing Children's Hospital Affiliated to Nanjing Medical University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weibing Tang, Dr. Weibing Tang, Nanjing Children's Hospital
ClinicalTrials.gov Identifier: NCT02776176    
Other Study ID Numbers: WTang
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weibing Tang, Nanjing Children's Hospital:
enhanced recovery after surgery
hirschsprung disease
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities