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Completed

NCT Number: NCT01011023

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

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil de Mexico

Mexico City, 06720, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non application of nasogastric tube in the experimental group

Other

Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube

Primary outcomes

  1. beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.

    Time frame: first 5 postoperative days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Infantil de Mexico Federico Gomez

Other

Registry information

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Nov 11, 2009
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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