Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial

December 9, 2009 updated by: Hospital Infantil de Mexico Federico Gomez

Purpose:

To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children.

Methods:

Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES:

Demographic characteristics, operative time, anastomosis placement,

Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to:

  1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started.
  2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.

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, 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 a distal elective bowel anastomosis (ileum and colon).

Exclusion Criteria:

  • Proximal and non elective anastomosis
  • High risk groups:
  • Newborns
  • Upper gastrointestinal tract anastomosis (esophagus, gastric, duodenal or jejunal)
  • Bilious-digestive or rectal anastomosis
  • Immunosuppressed patients
  • Gastrostomy or any pre anastomotic derivation
  • Multiple anastomoses
  • Chronic intestinal obstruction
  • 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: 1. Experimental group: Early feeding:
After 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated.
Other: Early feeding
after 24 hours fasting period, with good abdominal conditions (once flatus passage of bowel movements without abdominal distention, vomiting, nausea or ileus) the oral fluids during 24 hours and then advanced to a regular diet as tolerated.
Active Comparator: Control group : Obligatory 5 day fasting
Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.
Other: 5 day fasting
Obligatory 5-day fasting because it was the therapeutic gold standard at our hospital and our country. Both groups without NGT and antiemetic drug. 5-day antibiotic regimen, ranitidine and appropriate analgesics were used. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need to insert a NGT, beginning peristalsis, beginning bowel movement, 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 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

  • Principal Investigator: ROBERTO DAVILA-PEREZ, SURGEON, Hospital Infantil de Mexico
  • Study Chair: EDUARDO BRACHO-BLANCHET, SURGEON, Hospital Infantil de Mexico
  • Study Chair: JOSE MANUEL TOVILLA-MERCADO, SURGEON, Hospital Infantil de Mexico
  • Study Chair: PABLO LEZAMA-DEL-VALLE, SURGEON, Hospital Infantil de Mexico
  • Study Chair: GUSTAVO VARELA-FASCINETTO, SURGEON, Hospital Infantil de Mexico
  • Study Chair: JAIME NIETO-ZERMEÑO, SURGEON, 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

June 1, 2003

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • robdape2

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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