Viewing Study NCT02261454



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Study NCT ID: NCT02261454
Status: WITHDRAWN
Last Update Posted: 2018-03-20
First Post: 2014-08-20

Brief Title: RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
Sponsor: Alberta Childrens Hospital
Organization: Alberta Childrens Hospital

Study Overview

Official Title: The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years
Status: WITHDRAWN
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GUM_RCT
Brief Summary: Traditional postoperative care has been challenged recently to improve and speedup recovery including the return of bowel function such that patients can be discharged to home more quickly This approach includes earlier mobilization of the patient and introducing solid food sooner Additionally there is evidence in adults to suggest that sham feeding by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier

The aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery
Detailed Description: After intestinal surgery many patients suffer from a postoperative ileus POI The cause is multifactorial and can be attributed to surgery itself the lingering effect of the anesthetic the use of narcotics and decreased mobility of the patient

An ileus can delay the time to full diet thus lengthening the hospital stay of the patient - sometimes up to several weeks

There is evidence that early drinkingeating and increased mobility may accelerate the return of bowel function Fast-tracking is well documented in the adult literature protocols have been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus Fast-tracking has been done in pediatric patients but not in a large RCT for abdominal surgery

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None