An interventional study of Non application of nasogastric tube in the experimental group in Unnecessary Nasogastric Tube and Bowel Anastomosis, sponsored by Hospital Infantil de Mexico Federico Gomez. Completed at 1 site in Mexico. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2009-11-11.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Not applicable, Interventional, and Treatment
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.
Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Non elective anastomosis and high risk groups:
1. Experimental group (EG): without NGT, by removing the NGT at the end of the surgery, once the stomach had been aspirated,
Other: Non application of nasogastric tube in the experimental group
2. Control group (CG): with NGT, with radiographic corroboration of correct placement after the surgery. Both groups were given: 5-day fasting because it was the therapeutic gold standard at our hospital and our country, intravenous solutions and antibiotics for 5 days, ranitidine, and analgesics, without use of any antiemetic drug. Once the fasting period ended, in the CG the NGT was clamped and withdrawn, and in both groups oral fluids and diet were started. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.
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
beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.
Time frame: first 5 postoperative days
mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence, gastrointestinal bleeding, and chief complaint as well as anastomotic leak or dehiscence, reoperation and death.
Time frame: first 30 postoperative days
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez