Enhanced Recovery After Surgery In Hirschsprung Disease

Hirschsprung Disease Clinical Trial

— ERASIHD  

Official title:

A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02776176
• Other study ID #: WTang
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2016
• Last updated: May 18, 2016
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2016
• Source: Nanjing Children's Hospital
• Contact: Weibing Tang, MD&PhD
• Phone: +86 13851683700
• Email: twbcn[@]njmu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Hirschsprung Disease

Exclusion Criteria:

• with other disease

• receive emergency surgery

• need to do the ostomy

• full colonic Hirschsprung Disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirschsprung Disease

Intervention

Procedure:
• Enhanced Recovery After Surgery Program
optimized peri-operative protocol
• Traditional Program
traditional standard protocol

Locations

Country	Name	City	State
China	The Children's Hospital Of Soochow University	Suzhou	Jiangsu
China	Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group	Wuxi	Jiangsu
China	Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College	Xuzhou	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Weibing Tang	Soochow University, Wuxi People's Hospital, Xuzhou Medical College

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28. Review. — View Citation

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review. — View 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. — View 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. — View Citation

Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS® 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26. — View Citation

Mortensen K, Nilsson M, Slim K, Schäfer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21. — View 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. Epub 2005 Apr 9. — View 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®) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median length of postoperative hospital day		30days	Yes
Secondary	postoperative complications rates		within 30 days	Yes
Secondary	gastrointestinal functional recovery time		within 30 days	Yes
Secondary	mean cost per patient		within 30 days	Yes
Secondary	the readmission rates		within 30 days	Yes
Secondary	the level of stress and inflammation marker		within 30 days	Yes