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

This study has been completed.
Sponsor:
Information provided by:
Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier:
NCT01011023
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Unnecessary Nasogastric Tube
Bowel Anastomosis
Other: Non application of nasogastric tube in the experimental group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study

Resource links provided by NLM:


Further study details as provided by Hospital Infantil de Mexico Federico Gomez:

Primary Outcome Measures:
  • beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay. [ Time Frame: first 5 postoperative days ] [ Designated as safety issue: No ]

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. [ Time Frame: first 30 postoperative days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: September 2000
Study Completion Date: November 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01011023

Locations
Mexico
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
  More Information

Publications:

Responsible Party: DAVILA-PEREZ ROBERTO, PEDIATRIC SURGERY DEPARTMENT HOSPITAL INFANTIL DE MEXICO
ClinicalTrials.gov Identifier: NCT01011023     History of Changes
Other Study ID Numbers: robdape1
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Infantil de Mexico Federico Gomez:
Bowel anastomosis
nasogastric tube
children

ClinicalTrials.gov processed this record on October 21, 2014