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

This study has been completed.
Sponsor:
Information provided by:
Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier:
NCT01028807
First received: December 8, 2009
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

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.

Condition Intervention
Early Feeding
Bowel Anastomosis
Other: Early feeding
Other: 5 day fasting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Infantil de Mexico Federico Gomez:

Primary Outcome Measures:
  • Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. [ Time Frame: First 5 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: June 2003
Study Completion Date: November 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01028807

Locations
Mexico
Hospital Infantil de Mexico
Mexico Df, DF, Mexico, 06720
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: ROBERTO DAVILA PEREZ, HOSPITAL INFANTIL DE MEXICO
ClinicalTrials.gov Identifier: NCT01028807     History of Changes
Other Study ID Numbers: robdape2
Study First Received: December 8, 2009
Last Updated: December 9, 2009
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Infantil de Mexico Federico Gomez:
Early feeding
Bowel anastomosis
Children

ClinicalTrials.gov processed this record on October 29, 2014