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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01028807
Enrollment
60
Registered
2009-12-09
Start date
2003-06-30
Completion date
2004-11-30
Last updated
2009-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Feeding, Bowel Anastomosis

Keywords

Early feeding, Bowel anastomosis, Children

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.

Interventions

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.

OTHER5 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

Hospital Infantil de Mexico Federico Gomez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and deathFirst 30 postoperative days

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026