Clinical Trial: Enhanced Recovery After Surgery In Hirschsprung Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Weibing Tang

Current Primary Outcome: median length of postoperative hospital day [ Time Frame: 30days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • postoperative complications rates [ Time Frame: within 30 days ]
  • gastrointestinal functional recovery time [ Time Frame: within 30 days ]
  • mean cost per patient [ Time Frame: within 30 days ]
  • the readmission rates [ Time Frame: within 30 days ]
  • the level of stress and inflammation marker [ Time Frame: within 30 days ]


Original Secondary Outcome: Same as current

Information By: Nanjing Children's Hospital

Dates:
Date Received: May 15, 2016
Date Started: January 2016
Date Completion: December 2019
Last Updated: May 18, 2016
Last Verified: May 2016