Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xuzhou Medical University | OTHER |
| Soochow University | OTHER |
| Wuxi People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Patients receive the Enhanced Recovery After Surgery program during the peri-operative period. |
|
| Traditional group | Other | Patients receive the Traditional program during the peri-operative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery Program | Procedure | optimized peri-operative protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| median length of postoperative hospital day | 30days |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications rates | within 30 days | |
| gastrointestinal functional recovery time | within 30 days | |
| mean cost per patient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Tang, MD&PhD | Contact | +86 13851683700 | twbcn@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weibing Tang, MD&PhD | Nanjing Children's Hospital Affiliated to Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital Of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14667752 | Background | 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. | |
| 25391731 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006627 | Hirschsprung Disease |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional Program | Procedure | traditional standard protocol |
|
| within 30 days |
| the readmission rates | within 30 days |
| the level of stress and inflammation marker | within 30 days |
| Wuxi Children's Hospital Affiliated to Wuxi People's Hospital Group | Recruiting | Wuxi | Jiangsu | 214000 | China |
|
| Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College | Recruiting | Xuzhou | Jiangsu | 210000 | China |
|
| 25791027 | Background | 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. |
| 15896433 | Background | 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. |
| 16363014 | Background | 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. |
| 23079762 | Background | 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. |
| 23062720 | Background | 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. |
| 23099039 | Background | 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. |
| 25047143 | Background | 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. |
| 31676258 | Derived | 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. |
| 31535199 | Derived | 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. |
| D007410 |
| Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |