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

Summary

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.

Conditions

• Early Feeding
• Bowel Anastomosis

Interventions

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.

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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez

  lead OTHER

Principal Investigators

• ROBERTO DAVILA-PEREZ, SURGEON · HOSPITAL INFANTIL DE MEXICO

• EDUARDO BRACHO-BLANCHET, SURGEON · HOSPITAL INFANTIL DE MEXICO

• JOSE MANUEL TOVILLA-MERCADO, SURGEON · HOSPITAL INFANTIL DE MEXICO

• PABLO LEZAMA-DEL-VALLE, SURGEON · HOSPITAL INFANTIL DE MEXICO

• GUSTAVO VARELA-FASCINETTO, SURGEON · HOSPITAL INFANTIL DE MEXICO

• JAIME NIETO-ZERMEÑO, SURGEON · HOSPITAL INFANTIL DE MEXICO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2004-05-31

Completion

2004-11-30

Countries

• Mexico

Study Locations