Clinical Trial: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
Brief Summary: The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.
Detailed Summary:
Sponsor: Hamilton Health Sciences Corporation
Current Primary Outcome: Feasibility [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- post-operative length of stay [ Time Frame: 1 year ]
- rates of post-operative emesis [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: McMaster University
Dates:
Date Received: June 7, 2010
Date Started: January 2010
Date Completion:
Last Updated: September 25, 2015
Last Verified: September 2015
