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

Purpose

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:

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.
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.

Condition	Intervention
Early Feeding Bowel Anastomosis	Other: Early feeding Other: 5 day fasting

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by Hospital Infantil de Mexico Federico Gomez:

Primary Outcome Measures:

Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. [ Time Frame: First 5 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	June 2003
Study Completion Date:	November 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Experimental group: 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.	Other: 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.
Active Comparator: Control group : Obligatory 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.	Other: 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.

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028807

Locations

Mexico
Hospital Infantil de Mexico
Mexico Df, DF, Mexico, 06720

Sponsors and Collaborators

Hospital Infantil de Mexico Federico Gomez

Investigators

Principal Investigator:	ROBERTO DAVILA-PEREZ, SURGEON	HOSPITAL INFANTIL DE MEXICO
Study Chair:	EDUARDO BRACHO-BLANCHET, SURGEON	HOSPITAL INFANTIL DE MEXICO
Study Chair:	JOSE MANUEL TOVILLA-MERCADO, SURGEON	HOSPITAL INFANTIL DE MEXICO
Study Chair:	PABLO LEZAMA-DEL-VALLE, SURGEON	HOSPITAL INFANTIL DE MEXICO
Study Chair:	GUSTAVO VARELA-FASCINETTO, SURGEON	HOSPITAL INFANTIL DE MEXICO
Study Chair:	JAIME NIETO-ZERMEÑO, SURGEON	HOSPITAL INFANTIL DE MEXICO

More Information

Publications:

Gökpinar I, Gürleyik E, Pehlivan M, Ozcan O, Ozaydin I, Aslaner A, Demiraran Y, Gültepe M. [Early enteral and glutamine enriched enteral feeding ameliorates healing of colonic anastomosis: experimental study] Ulus Travma Acil Cerrahi Derg. 2006 Jan;12(1):17-21. Turkish.

Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. Review.

Seenu V, Goel AK. Early oral feeding after elective colorectal surgery: is it safe. Trop Gastroenterol. 1995 Oct-Dec;16(4):72-3.

Senkal M, Mumme A, Eickhoff U, Geier B, Spath G, Wulfert D, Joosten U, Frei A, Kemen M. Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients. Crit Care Med. 1997 Sep;25(9):1489-96.

Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. Review.

Feo CV, Romanini B, Sortini D, Ragazzi R, Zamboni P, Pansini GC, Liboni A. Early oral feeding after colorectal resection: a randomized controlled study. ANZ J Surg. 2004 May;74(5):298-301.

Lucha PA Jr, Butler R, Plichta J, Francis M. The economic impact of early enteral feeding in gastrointestinal surgery: a prospective survey of 51 consecutive patients. Am Surg. 2005 Mar;71(3):187-90.

Sangkhathat S, Patrapinyokul S, Tadyathikom K. Early enteral feeding after closure of colostomy in pediatric patients. J Pediatr Surg. 2003 Oct;38(10):1516-9.

Pearl ML, Valea FA, Fischer M, Mahler L, Chalas E. A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol. 1998 Jul;92(1):94-7.

Stewart BT, Woods RJ, Collopy BT, Fink RJ, Mackay JR, Keck JO. Early feeding after elective open colorectal resections: a prospective randomized trial. Aust N Z J Surg. 1998 Feb;68(2):125-8.

Han-Geurts IJ, Hop WC, Kok NF, Lim A, Brouwer KJ, Jeekel J. Randomized clinical trial of the impact of early enteral feeding on postoperative ileus and recovery. Br J Surg. 2007 May;94(5):555-61.

Responsible Party:	ROBERTO DAVILA PEREZ, HOSPITAL INFANTIL DE MEXICO
ClinicalTrials.gov Identifier:	NCT01028807 History of Changes
Other Study ID Numbers:	robdape2
Study First Received:	December 8, 2009
Last Updated:	December 9, 2009
Health Authority:	Mexico: Ethics Committee

Keywords provided by Hospital Infantil de Mexico Federico Gomez:

Early feeding
Bowel anastomosis
Children

Additional relevant MeSH terms:

Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013