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Completed

NCT Number: NCT01028807

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

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.

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Key information

Conditions

Early Feeding Bowel Anastomosis

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil de Mexico

Mexico City, 06720, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early feeding

Other

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.

5 day fasting

Other

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 outcomes

  1. Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.

    Time frame: First 5 postoperative days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Infantil de Mexico Federico Gomez

Other

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 9, 2009
Registry last updated
Dec 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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