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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01011023
Enrollment
60
Registered
2009-11-11
Start date
2000-09-30
Completion date
2001-11-30
Last updated
2009-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Anastomosis, Unnecessary Nasogastric Tube

Keywords

Bowel anastomosis, nasogastric tube, children

Brief 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.

Interventions

OTHERNon 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

Sponsors

Hospital Infantil de Mexico Federico Gomez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.first 5 postoperative days

Secondary

MeasureTime 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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026