Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study

NCT01011023 | Completed DMC

• 1 other identifier: robdape1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with \<b\>distal\</b\> 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). \<b\>As an equivalence study the investigators expected that the two techniques were equivalent.\</b\> 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. \<b\>Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups.\</b\> 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.

Conditions

Unnecessary Nasogastric Tube; Bowel Anastomosis

Keywords

Bowel anastomosis; nasogastric tube; children

Outcome Measures

Primary Outcomes (1)

• beginning peristalsis, beginning bowel movement, beginning ambulation, 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, gastrointestinal bleeding, and chief complaint as well as anastomotic leak or dehiscence, reoperation and death.

  first 30 postoperative days

Study Arms (2)

WITHOUT NASOGASTRIC TUBE

EXPERIMENTAL

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

WITH NASOGASTRIC TUBE

ACTIVE COMPARATOR

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

Interventions

Non application of nasogastric tube in the experimental group OTHER

Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube

WITH NASOGASTRIC TUBE; WITHOUT NASOGASTRIC TUBE

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 an intestinal anastomosis (jejunum, ileum and colon).

You may not qualify if:

• 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.

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)

• 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. doi: 10.1016/s0022-3468(97)90382-1.

  PMID: 9247217 BACKGROUND

• 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. doi: 10.1007/s003830050351.

  PMID: 9639629 BACKGROUND

• 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. doi: 10.1016/0002-9610(80)90395-5.

  PMID: 7386740 BACKGROUND

• 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. doi: 10.1097/00000658-199505000-00004.

  PMID: 7748028 BACKGROUND

• 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. doi: 10.1097/00000658-198906000-00003.

  PMID: 2658880 BACKGROUND

• Savassi-Rocha PR, Conceicao 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.

  PMID: 1553612 BACKGROUND

• 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.

  PMID: 1458389 BACKGROUND

• Ordorica-Flores RM, Bracho-Blanchet E, Nieto-Zermeno 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. doi: 10.1016/s0022-3468(98)90279-2.

  PMID: 9869045 BACKGROUND

• Nelson R, Tse B, Edwards S. Systematic review of prophylactic nasogastric decompression after abdominal operations. Br J Surg. 2005 Jun;92(6):673-80. doi: 10.1002/bjs.5090.

  PMID: 15912492 BACKGROUND

• Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004929. doi: 10.1002/14651858.CD004929.pub3.

  PMID: 17636780 BACKGROUND

• Rogers JL, Howard KI, Vessey JT. Using significance tests to evaluate equivalence between two experimental groups. Psychol Bull. 1993 May;113(3):553-65. doi: 10.1037/0033-2909.113.3.553.

  PMID: 8316613 BACKGROUND

Study Officials

• ROBERTO DAVILA, SURGEON

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

• 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 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: November 10, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2000
• Primary Completion: April 1, 2001
• Study Completion: November 1, 2001
• Last Updated: November 11, 2009

Record last verified: 2009-11

Locations

ME (1)