Clinical trial NCT01028807: Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
Official title: Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Feeding
Bowel Anastomosis
Keywords: Early feeding
Bowel anastomosis
Children
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay.
timeFrame: First 5 postoperative days
Secondary outcomes:
measure: Mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death
timeFrame: First 30 postoperative days
Other outcomes:
Locations:
city: Mexico Df
country: Mexico
facility: Hospital Infantil de Mexico
state: DF
Study officials:
affiliation: HOSPITAL INFANTIL DE MEXICO
name: ROBERTO DAVILA-PEREZ, SURGEON
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: EDUARDO BRACHO-BLANCHET, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: JOSE MANUEL TOVILLA-MERCADO, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: PABLO LEZAMA-DEL-VALLE, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: GUSTAVO VARELA-FASCINETTO, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: JAIME NIETO-ZERMEÑO, SURGEON
role: STUDY_CHAIR
References:
citation: Gokpinar I, Gurleyik E, Pehlivan M, Ozcan O, Ozaydin I, Aslaner A, Demiraran Y, Gultepe 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.
citation: 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. doi: 10.1097/00000658-199507000-00012.
citation: Seenu V, Goel AK. Early oral feeding after elective colorectal surgery: is it safe. Trop Gastroenterol. 1995 Oct-Dec;16(4):72-3.
citation: 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. doi: 10.1097/00003246-199709000-00015.
citation: Bisgaard T, Kehlet H. Early oral feeding after elective abdominal surgery--what are the issues? Nutrition. 2002 Nov-Dec;18(11-12):944-8. doi: 10.1016/s0899-9007(02)00990-5.
citation: 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. doi: 10.1111/j.1445-1433.2004.02985.x.
citation: 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.
citation: 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. doi: 10.1016/s0022-3468(03)00506-2.
citation: 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. doi: 10.1016/s0029-7844(98)00114-8.
citation: 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. doi: 10.1111/j.1445-2197.1998.tb04721.x.
citation: 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. doi: 10.1002/bjs.5753.