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

Not Applicable

Completed

• Conditions: Early Feeding; Bowel Anastomosis
• Interventions: Other: Early feeding; Other: 5 day fasting

• Registration Number: NCT01028807
• Lead Sponsor: Hospital Infantil de Mexico Federico Gomez

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-05
• Study Completion: 2004-11
• Status Verified: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Submitted: 2009-12-09
• Last Update Posted: 2009-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Experimental group: Early feeding:	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.
Control group : Obligatory 5 day fasting	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.

Primary Outcome Measures

Name	Time	Method
Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.	First 5 postoperative days

Secondary Outcome Measures

Name	Time	Method
Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death	First 30 postoperative days

Trial Locations

Locations (1)

Hospital Infantil de Mexico; 🇲🇽 Mexico Df, DF, Mexico