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

NCT01028807 | Completed DMC

• 1 other identifier: robdape2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Early Feeding; Bowel Anastomosis

Keywords

Early feeding; Bowel anastomosis; Children

Outcome Measures

Primary Outcomes (1)

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

  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

  First 30 postoperative days

Study Arms (2)

1. Experimental group: Early feeding:

EXPERIMENTAL

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

Control group : Obligatory 5 day fasting

ACTIVE COMPARATOR

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

Interventions

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.

1. Experimental group: Early feeding:

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.

Control group : Obligatory 5 day fasting

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de Mexico

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (11)

• 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.

  PMID: 16456746 BACKGROUND

• 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.

  PMID: 7618972 BACKGROUND

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

  PMID: 8854962 BACKGROUND

• 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.

  PMID: 9295822 BACKGROUND

• 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.

  PMID: 12431715 BACKGROUND

• 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.

  PMID: 15144242 BACKGROUND

• 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.

  PMID: 15869128 BACKGROUND

• 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.

  PMID: 14577078 BACKGROUND

• 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.

  PMID: 9649101 BACKGROUND

• 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.

  PMID: 9494004 BACKGROUND

• 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.

  PMID: 17443854 BACKGROUND

Study Officials

• ROBERTO DAVILA-PEREZ, SURGEON

  HOSPITAL INFANTIL DE MEXICO

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: June 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: November 1, 2004
• Last Updated: December 10, 2009

Record last verified: 2009-12

Locations

ME (1)