Enhanced Recovery After Surgery In Hirschsprung Disease

NCT ID: NCT02776176

Last Updated: 2016-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hirschsprung Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ERAS group

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

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery Program

Intervention Type PROCEDURE

optimized peri-operative protocol

Traditional group

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

Group Type OTHER

Traditional Program

Intervention Type PROCEDURE

traditional standard protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enhanced Recovery After Surgery Program

optimized peri-operative protocol

Intervention Type PROCEDURE

Traditional Program

traditional standard protocol

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fast Track Surgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of Hirschsprung Disease

Exclusion Criteria

* with other disease
* receive emergency surgery
* need to do the ostomy
* full colonic Hirschsprung Disease
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuzhou Medical University

OTHER

Sponsor Role collaborator

Soochow University

OTHER

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Weibing Tang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weibing Tang

Dr. Weibing Tang

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Weibing Tang, MD&PhD

Role: STUDY_CHAIR

Nanjing Children's Hospital Affiliated to Nanjing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital Of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

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

Wuxi, Jiangsu, China

Site Status RECRUITING

Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Weibing Tang, MD&PhD

Role: CONTACT

+86 13851683700

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shungen Huang, MD

Role: primary

+86 13776088680

Yingzuo Shi, Master

Role: primary

+86 13861800138

Hongwei Zhang, bachelor

Role: primary

+86 18952173385

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14667752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25391731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25791027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15896433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16363014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23079762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23099039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25047143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31676258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31535199 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WTang

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.