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Status unknownNCT02776176ERASIHDUpdated May 19, 2016

Enhanced Recovery After Surgery In Hirschsprung Disease

An interventional study of Enhanced Recovery After Surgery Program and Traditional Program in Hirschsprung Disease, sponsored by Weibing Tang. Status unknown at 3 sites in China. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by Weibing Tang · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
Up to 14 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Hirschsprung Disease

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Keywords

  • enhanced recovery after surgery
  • hirschsprung disease
03

In context

Hirschsprung Disease

66 studies on the registry are indexed under Hirschsprung Disease; 23 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 34 interventional studies indexed under Hirschsprung Disease.

Browse Hirschsprung Disease studies →

Lead sponsor

Weibing Tang is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of Hirschsprung Disease

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    ERAS group

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

    Procedure: Enhanced Recovery After Surgery Program

  • Other
    Traditional group

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

    Procedure: Traditional Program

Interventions

  • ProcedureEnhanced Recovery After Surgery Program

    optimized peri-operative protocol

    Also known as: Fast Track Surgery

  • ProcedureTraditional Program

    traditional standard protocol

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What researchers measure

Primary outcomes

  1. median length of postoperative hospital day

    Time frame: 30days

Secondary outcomes

  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

07

Study locations

3 of 3 sites recruiting
  • The Children's Hospital Of Soochow University
    Suzhou, Jiangsu 215000, China
    Recruiting
  • Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group
    Wuxi, Jiangsu 214000, China
    Recruiting
  • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
    Xuzhou, Jiangsu 210000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 14667752 ↗
  • 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. PubMed 25391731 ↗
  • 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. PubMed 25791027 ↗
  • 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. PubMed 15896433 ↗
  • 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. PubMed 16363014 ↗
  • 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. PubMed 23079762 ↗
  • 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. PubMed 23062720 ↗
  • 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. PubMed 23099039 ↗
  • 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. PubMed 25047143 ↗
  • 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. PubMed 31676258 ↗
  • 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. PubMed 31535199 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02776176
Lead sponsor
Weibing Tang
Collaborators
Xuzhou Medical University, Soochow University, Wuxi People's Hospital
Responsible party
Weibing Tang (Dr. Weibing Tang, Nanjing Children's Hospital) — Sponsor-investigator
First posted
May 18, 2016
Start date
Jan 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
May 19, 2016

Study contacts

Weibing Tang, MD&PhD
Contact
twbcn@njmu.edu.cn
+86 13851683700
Weibing Tang, MD&PhD
study chair · Nanjing Children's Hospital Affiliated to Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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