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

NCT ID: NCT01011023

Last Updated: 2009-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2001-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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,

Group Type: EXPERIMENTAL

Non application of nasogastric tube in the experimental group

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Non application of nasogastric tube in the experimental group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role: lead

Responsible Party

PEDIATRIC SURGERY DEPARTMENT HOSPITAL INFANTIL DE MEXICO

Principal Investigators

ROBERTO DAVILA, SURGEON

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil de Mexico Federico Gomez

EDUARDO BRACHO-BLANCHET, SURGEON

Role: STUDY_CHAIR

HOSPITAL INFATIL DE MEXICO FEDERICO GOMEZ

JOSE MANUEL TOVILLA-MERCADO, SURGEON

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

RICARDO REYES-RETANA, SURGEON

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

PABLO LEZAMA-DEL-VALLE, SURGEON

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

JOSE ALEJANDRO HERNANDEZ-PLATA, SURGERY

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

FERNANDO MONTES-TAPIA, SURGERY

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

ALFONSO REYES-LOPEZ, STATISTIC

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

JAIME NIETO-ZERMEÑO, SURGEON

Role: STUDY_CHAIR

HOSPITAL INFANTIL DE MEXICO

Locations

Hospital Infantil de Mexico

Mexico City, Mexico City, Mexico

Countries

Mexico

References

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Other Identifiers

robdape1

Identifier Type: -

Identifier Source: org_study_id