search
Back to results

Enhanced Recovery After Surgery In Hirschsprung Disease (ERASIHD)

Primary Purpose

Hirschsprung Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced Recovery After Surgery Program
Traditional Program
Sponsored by
Weibing Tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hirschsprung Disease focused on measuring enhanced recovery after surgery, hirschsprung disease

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • The Children's Hospital Of Soochow UniversityRecruiting
  • Wuxi Children's Hospital Affiliated to Wuxi People's Hospital GroupRecruiting
  • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ERAS group

Traditional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

median length of postoperative hospital day

Secondary Outcome Measures

postoperative complications rates
gastrointestinal functional recovery time
mean cost per patient
the readmission rates
the level of stress and inflammation marker

Full Information

First Posted
May 15, 2016
Last Updated
May 18, 2016
Sponsor
Weibing Tang
Collaborators
Xuzhou Medical University, Soochow University, Wuxi People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02776176
Brief Title
Enhanced Recovery After Surgery In Hirschsprung Disease
Acronym
ERASIHD
Official Title
A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weibing Tang
Collaborators
Xuzhou Medical University, Soochow University, Wuxi People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirschsprung Disease
Keywords
enhanced recovery after surgery, hirschsprung disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
Patients receive the Enhanced Recovery After Surgery program during the peri-operative period.
Arm Title
Traditional group
Arm Type
Other
Arm Description
Patients receive the Traditional program during the peri-operative period.
Intervention Type
Procedure
Intervention Name(s)
Enhanced Recovery After Surgery Program
Other Intervention Name(s)
Fast Track Surgery
Intervention Description
optimized peri-operative protocol
Intervention Type
Procedure
Intervention Name(s)
Traditional Program
Intervention Description
traditional standard protocol
Primary Outcome Measure Information:
Title
median length of postoperative hospital day
Time Frame
30days
Secondary Outcome Measure Information:
Title
postoperative complications rates
Time Frame
within 30 days
Title
gastrointestinal functional recovery time
Time Frame
within 30 days
Title
mean cost per patient
Time Frame
within 30 days
Title
the readmission rates
Time Frame
within 30 days
Title
the level of stress and inflammation marker
Time Frame
within 30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weibing Tang, MD&PhD
Phone
+86 13851683700
Email
twbcn@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weibing Tang, MD&PhD
Organizational Affiliation
Nanjing Children's Hospital Affiliated to Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Children's Hospital Of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shungen Huang, MD
Phone
+86 13776088680
Email
drhuang01@163.com
Facility Name
Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingzuo Shi, Master
Phone
+86 13861800138
Email
shiyz@wuxiph.com
Facility Name
Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Zhang, bachelor
Phone
+86 18952173385
Email
pingweizz@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14667752
Citation
Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
Results Reference
background
PubMed Identifier
25391731
Citation
Kehlet H. Enhanced Recovery After Surgery (ERAS): good for now, but what about the future? Can J Anaesth. 2015 Feb;62(2):99-104. doi: 10.1007/s12630-014-0261-3. Epub 2014 Nov 13. No abstract available.
Results Reference
background
PubMed Identifier
25791027
Citation
Bakker N, Cakir H, Doodeman HJ, Houdijk AP. Eight years of experience with Enhanced Recovery After Surgery in patients with colon cancer: Impact of measures to improve adherence. Surgery. 2015 Jun;157(6):1130-6. doi: 10.1016/j.surg.2015.01.016. Epub 2015 Mar 16.
Results Reference
background
PubMed Identifier
15896433
Citation
Nygren J, Hausel J, Kehlet H, Revhaug A, Lassen K, Dejong C, Andersen J, von Meyenfeldt M, Ljungqvist O, Fearon KC. A comparison in five European Centres of case mix, clinical management and outcomes following either conventional or fast-track perioperative care in colorectal surgery. Clin Nutr. 2005 Jun;24(3):455-61. doi: 10.1016/j.clnu.2005.02.003. Epub 2005 Apr 9.
Results Reference
background
PubMed Identifier
16363014
Citation
King PM, Blazeby JM, Ewings P, Franks PJ, Longman RJ, Kendrick AH, Kipling RM, Kennedy RH. Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. Br J Surg. 2006 Mar;93(3):300-8. doi: 10.1002/bjs.5216.
Results Reference
background
PubMed Identifier
23079762
Citation
Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.
Results Reference
background
PubMed Identifier
23062720
Citation
Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
Results Reference
background
PubMed Identifier
23099039
Citation
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28.
Results Reference
background
PubMed Identifier
25047143
Citation
Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
Results Reference
background
PubMed Identifier
31676258
Citation
Tang J, Liu X, Ma T, Lv X, Jiang W, Zhang J, Lu C, Chen H, Li W, Li H, Xie H, Du C, Geng Q, Feng J, Tang W. Application of enhanced recovery after surgery during the perioperative period in infants with Hirschsprung's disease - A multi-center randomized clinical trial. Clin Nutr. 2020 Jul;39(7):2062-2069. doi: 10.1016/j.clnu.2019.10.001. Epub 2019 Oct 16.
Results Reference
derived
PubMed Identifier
31535199
Citation
Lu C, Xie H, Li H, Geng Q, Chen H, Mo X, Tang W. Feasibility and efficacy of home rectal irrigation in neonates and early infancy with Hirschsprung disease. Pediatr Surg Int. 2019 Nov;35(11):1245-1253. doi: 10.1007/s00383-019-04552-8. Epub 2019 Sep 18.
Results Reference
derived

Learn more about this trial

Enhanced Recovery After Surgery In Hirschsprung Disease

We'll reach out to this number within 24 hrs