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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unnecessary Nasogastric Tube, Bowel Anastomosis

Intervention / Treatment
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* Other: Non application of nasogastric tube in the experimental group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients between the ages of 1 month to 18 years old that required elective laparotomy with an intestinal anastomosis (jejunum, ileum and colon). Exclusion Criteria: Non elective anastomosis and high risk groups: newborns upper gastrointestinal tract anastomoses (esophagus, gastric, duodenal or jejunal) bilious-digestive or rectal anastomoses immunosuppressed patients gastrostomy or any pre anastomotic derivation multiple anastomoses chronic intestinal obstruction intraoperative fluids-electrolyte disorders reductive enteroplasty (tapering) emergency operations and patients who did not complete the minimum POP follow up of one month.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WITHOUT NASOGASTRIC TUBE<br>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<br>* Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube<br>|
| Active Comparator: WITH NASOGASTRIC TUBE<br>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<br>* Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay. |  | first 5 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | first 30 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel anastomosis, nasogastric tube, children