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

November 10, 2009 updated by: Hospital Infantil de Mexico Federico Gomez
Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with distal 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). As an equivalence study the investigators expected that the two techniques were equivalent. 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. Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico, DF, Mexico, 06720
        • Hospital Infantil de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: first 30 postoperative days
first 30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil de Mexico Federico Gomez

Investigators

  • Study Chair: JOSE MANUEL TOVILLA-MERCADO, SURGEON, Hospital Infantil de Mexico
  • Study Chair: PABLO LEZAMA-DEL-VALLE, SURGEON, Hospital Infantil de Mexico
  • Study Chair: JAIME NIETO-ZERMEÑO, SURGEON, Hospital Infantil de Mexico
  • Principal Investigator: ROBERTO DAVILA, SURGEON, Hospital Infantil de Mexico Federico Gomez
  • Study Chair: EDUARDO BRACHO-BLANCHET, SURGEON, HOSPITAL INFATIL DE MEXICO FEDERICO GOMEZ
  • Study Chair: RICARDO REYES-RETANA, SURGEON, Hospital Infantil de Mexico
  • Study Chair: JOSE ALEJANDRO HERNANDEZ-PLATA, SURGERY, Hospital Infantil de Mexico
  • Study Chair: FERNANDO MONTES-TAPIA, SURGERY, Hospital Infantil de Mexico
  • Study Chair: ALFONSO REYES-LOPEZ, STATISTIC, Hospital Infantil de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

April 1, 2001

Study Completion (Actual)

November 1, 2001

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • robdape1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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