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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Need to insert a NGT, beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. | First 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infantil de Mexico | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16456746 | Background | 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. | |
| 7618972 | 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. |
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| 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. |
|
| 8854962 | Background | Seenu V, Goel AK. Early oral feeding after elective colorectal surgery: is it safe. Trop Gastroenterol. 1995 Oct-Dec;16(4):72-3. |
| 9295822 | 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. |
| 12431715 | 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. |
| 15144242 | 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. |
| 15869128 | 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. |
| 14577078 | 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. |
| 9649101 | 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. |
| 9494004 | 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. |
| 17443854 | 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. |