Bowel Anastomosis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05955495 -
Length of Stay Between Early Versus Delayed Oral Postoperative Feeding
|
N/A |