NCT01011023

Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Infantil de Mexico Federico Gomez · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with \<b\>distal\</b\> elective bowel anastomosis. Summary Background Data. Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in children and adults, to hasten bowel function, prevent post operative complications and shorten hospital stay. However, there is no former study that states in a scientific manner its benefit in children. Methods. The investigators performed a clinical controlled, randomized trial, comprising 60 children that underwent distal elective bowel anastomoses comparing post operative complications between a group with nasogastric tube in place (n=29) and one without it (n=31). \<b\>As an equivalence study the investigators expected that the two techniques were equivalent.\</b\> Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and chi square test for qualitative variables. Considering statistically significant a p-value less than 0.05. \<b\>Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups.\</b\> Results: Demographic data and diagnosis were comparable in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any patient. The investigators demonstrated equivalency since each confidence interval is entirely contained within delta, except for one variable (beginning deambulation), in which equivalency is suggested. There were no significant differences between groups in abdominal distention, infection, or hospital stay variables. Only one patient in the experimental group required placement of the nasogastric tube due to persistent abdominal distension (3.2%). Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective intestinal surgery in children. It's use should be individualized.

Conditions

• Unnecessary Nasogastric Tube
• Bowel Anastomosis

Interventions

Type	Name	Description
OTHER	Non application of nasogastric tube in the experimental group	Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube

Timeline

• Start date: 2000-09-01
• Primary completion: 2001-04-01
• Completion: 2001-11-01
• First posted: 2009-11-11
• Last updated: 2009-11-11

Locations

1 site across 1 country: Mexico