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

Bowel Anastomosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011023
• Other study ID #: robdape1
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: November 10, 2009
• Start date: September 2000
• Est. completion date: November 2001

Study information

• Verified date: November 2009
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Anastomosis
• Unnecessary Nasogastric Tube

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Infantil de Mexico	Mexico	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004929. Review. — View Citation

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. — View Citation

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. — View Citation

Rogers JL, Howard KI, Vessey JT. Using significance tests to evaluate equivalence between two experimental groups. Psychol Bull. 1993 May;113(3):553-65. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.		first 5 postoperative days	No
Secondary	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	Yes