Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study
Study Details
Study Description
Brief Summary
Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with distal elective bowel anastomosis. Summary Background Data. Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in children and adults, to hasten bowel function, prevent post operative complications and shorten hospital stay. However, there is no former study that states in a scientific manner its benefit in children. Methods. The investigators performed a clinical controlled, randomized trial, comprising 60 children that underwent distal elective bowel anastomoses comparing post operative complications between a group with nasogastric tube in place (n=29) and one without it (n=31). As an equivalence study the investigators expected that the two techniques were equivalent. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and chi square test for qualitative variables. Considering statistically significant a p-value less than 0.05. Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups. Results: Demographic data and diagnosis were comparable in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any patient. The investigators demonstrated equivalency since each confidence interval is entirely contained within delta, except for one variable (beginning deambulation), in which equivalency is suggested. There were no significant differences between groups in abdominal distention, infection, or hospital stay variables. Only one patient in the experimental group required placement of the nasogastric tube due to persistent abdominal distension (3.2%). Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective intestinal surgery in children. It's use should be individualized.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WITHOUT NASOGASTRIC TUBE 1. Experimental group (EG): without NGT, by removing the NGT at the end of the surgery, once the stomach had been aspirated, |
Other: Non application of nasogastric tube in the experimental group
Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube
|
| Active Comparator: WITH NASOGASTRIC TUBE 2. Control group (CG): with NGT, with radiographic corroboration of correct placement after the surgery. Both groups were given: 5-day fasting because it was the therapeutic gold standard at our hospital and our country, intravenous solutions and antibiotics for 5 days, ranitidine, and analgesics, without use of any antiemetic drug. Once the fasting period ended, in the CG the NGT was clamped and withdrawn, and in both groups oral fluids and diet were started. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards. |
Other: Non application of nasogastric tube in the experimental group
Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube
|
Outcome Measures
Primary Outcome Measures
- beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay. [first 5 postoperative days]
Secondary Outcome Measures
- mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence, gastrointestinal bleeding, and chief complaint as well as anastomotic leak or dehiscence, reoperation and death. [first 30 postoperative days]
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients between the ages of 1 month to 18 years old that required elective laparotomy with an intestinal anastomosis (jejunum, ileum and colon).
Exclusion Criteria:
-
Non elective anastomosis and high risk groups:
-
newborns
-
upper gastrointestinal tract anastomoses (esophagus, gastric, duodenal or jejunal)
-
bilious-digestive or rectal anastomoses
-
immunosuppressed patients
-
gastrostomy or any pre anastomotic derivation
-
multiple anastomoses
-
chronic intestinal obstruction
-
intraoperative fluids-electrolyte disorders
-
reductive enteroplasty (tapering)
-
emergency operations and patients who did not complete the minimum POP follow up of one month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Infantil de Mexico | Mexico | DF | Mexico | 06720 |
Sponsors and Collaborators
- Hospital Infantil de Mexico Federico Gomez
Investigators
- Principal Investigator: ROBERTO DAVILA, SURGEON, Hospital Infantil de Mexico Federico Gomez
- Study Chair: EDUARDO BRACHO-BLANCHET, SURGEON, HOSPITAL INFATIL DE MEXICO FEDERICO GOMEZ
- Study Chair: JOSE MANUEL TOVILLA-MERCADO, SURGEON, HOSPITAL INFANTIL DE MEXICO
- Study Chair: RICARDO REYES-RETANA, SURGEON, HOSPITAL INFANTIL DE MEXICO
- Study Chair: PABLO LEZAMA-DEL-VALLE, SURGEON, HOSPITAL INFANTIL DE MEXICO
- Study Chair: JOSE ALEJANDRO HERNANDEZ-PLATA, SURGERY, HOSPITAL INFANTIL DE MEXICO
- Study Chair: FERNANDO MONTES-TAPIA, SURGERY, HOSPITAL INFANTIL DE MEXICO
- Study Chair: ALFONSO REYES-LOPEZ, STATISTIC, HOSPITAL INFANTIL DE MEXICO
- Study Chair: JAIME NIETO-ZERMEÑO, SURGEON, HOSPITAL INFANTIL DE MEXICO
Study Documents (Full-Text)
None provided.More Information
Publications
- Argov S, Goldstein I, Barzilai A. Is routine use of the nasogastric tube justified in upper abdominal surgery? Am J Surg. 1980 Jun;139(6):849-50.
- Cheatham ML, Chapman WC, Key SP, Sawyers JL. A meta-analysis of selective versus routine nasogastric decompression after elective laparotomy. Ann Surg. 1995 May;221(5):469-76; discussion 476-8.
- Cunningham J, Temple WJ, Langevin JM, Kortbeek J. A prospective randomized trial of routine postoperative nasogastric decompression in patients with bowel anastomosis. Can J Surg. 1992 Dec;35(6):629-32.
- Dinsmore JE, Maxson RT, Johnson DD, Jackson RJ, Wagner CW, Smith SD. Is nasogastric tube decompression necessary after major abdominal surgery in children? J Pediatr Surg. 1997 Jul;32(7):982-4; discussion 984-5.
- Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004929. Review.
- Nelson R, Tse B, Edwards S. Systematic review of prophylactic nasogastric decompression after abdominal operations. Br J Surg. 2005 Jun;92(6):673-80. Review.
- Ordorica-Flores RM, Bracho-Blanchet E, Nieto-Zermeño J, Reyes-Retana R, Tovilla-Mercado JM, Leon-Villanueva V, Varela-Fascinetto G. Intestinal anastomosis in children: a comparative study between two different techniques. J Pediatr Surg. 1998 Dec;33(12):1757-9.
- Rogers JL, Howard KI, Vessey JT. Using significance tests to evaluate equivalence between two experimental groups. Psychol Bull. 1993 May;113(3):553-65.
- Sandler AD, Evans D, Ein SH. To tube or not to tube: do infants and children need post-laparotomy gastric decompression? Pediatr Surg Int. 1998 Jul;13(5-6):411-3.
- Savassi-Rocha PR, Conceicão SA, Ferreira JT, Diniz MT, Campos IC, Fernandes VA, Garavini D, Castro LP. Evaluation of the routine use of the nasogastric tube in digestive operation by a prospective controlled study. Surg Gynecol Obstet. 1992 Apr;174(4):317-20.
- Wolff BG, Pembeton JH, van Heerden JA, Beart RW Jr, Nivatvongs S, Devine RM, Dozois RR, Ilstrup DM. Elective colon and rectal surgery without nasogastric decompression. A prospective, randomized trial. Ann Surg. 1989 Jun;209(6):670-3; discussion 673-5.
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