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Hirschsprung DiseaseERASIHDNCT02776176

Enhanced Recovery After Surgery In Hirschsprung Disease

A study testing Enhanced Recovery After Surgery Program and Traditional Program in people with Hirschsprung Disease, run by Weibing Tang at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages Up to 14 years
Conditions the study is for
Hirschsprung Disease
What is being tested?
Enhanced Recovery After Surgery Program and Traditional Program
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesChina
Study dates
Jan 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Clinical diagnosis of Hirschsprung Disease

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Weibing Tang, MD&PhD contact

+86 13851683700

twbcn@njmu.edu.cn

China3 sites, 3 recruiting

  • The Children's Hospital Of Soochow University

    Suzhou, Jiangsu, 215000

    Shungen Huang, MD, +86 13776088680, drhuang01@163.com

    Recruiting

  • Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group

    Wuxi, Jiangsu, 214000

    Yingzuo Shi, Master, +86 13861800138, shiyz@wuxiph.com

    Recruiting

  • Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College

    Xuzhou, Jiangsu, 210000

    Hongwei Zhang, bachelor, +86 18952173385, pingweizz@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Being tested
Enhanced Recovery After Surgery Program, Traditional Program
Keywords
enhanced recovery after surgery, hirschsprung disease
Medical subject headings
Hirschsprung Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Recovery After Surgery ProgramProcedure or surgery

    Also called Fast Track Surgery

    optimized peri-operative protocol

  • Traditional ProgramProcedure or surgery

    traditional standard protocol

Study groups in NCT02776176
Study groupRoleWhat they receive
ERAS groupExperimentalPatients receive the Enhanced Recovery After Surgery program during the peri-operative period.
Receives: Procedure: Enhanced Recovery After Surgery Program
Traditional groupOtherPatients receive the Traditional program during the peri-operative period.
Receives: Procedure: Traditional Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. median length of postoperative hospital day

    Measured: 30days

Secondary outcomes (5)

  1. postoperative complications rates

    Measured: within 30 days

  2. gastrointestinal functional recovery time

    Measured: within 30 days

  3. mean cost per patient

    Measured: within 30 days

  4. the readmission rates

    Measured: within 30 days

  5. the level of stress and inflammation marker

    Measured: within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02776176
Sponsor's protocol ID
WTang
Acronym
ERASIHD
Status last verified
May 2016
First submitted
15 May 2016
Last updated
19 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Recovery After Surgery Program and Traditional Program in people with Hirschsprung Disease, run by Weibing Tang at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weibing Tang, MD&PhD (+86 13851683700, twbcn@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

median length of postoperative hospital day (time frame: 30days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02776176, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.

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