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

Hospital Infantil de Mexico Federico Gomez

Status: Completed

Conditions: Early Feeding; Bowel Anastomosis

Treatments: Other: 5 day fasting; Other: Early feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT01028807

robdape2

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1. Experimental group: Early feeding:

Experimental group

Description:

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.

Treatment:

Other: Early feeding

Control group : Obligatory 5 day fasting

Active Comparator group

Description:

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.

Treatment:

Other: 5 day fasting