Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy as a Route For Nutrition After Major Upper Gastrointestinal Operations

Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications After Gastrointestinal Operations

Detailed Description

A prospective randomized trial with patients undergoing esophagectomy, total gastrectomy or pancreaticoduodenectomy to asses the outcomes of either jejunostomy placement or catheter placement

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Universidade Federal De Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with gastrointestinal disorders undergoing major abdominal operations

Description

Inclusion Criteria:

• age over 18,
• gastrointestinal resections

Exclusion Criteria:

• age under 18,
• no gastrointestinal procedure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Jejunostomy; Patients who received a jejunostomy
Nasojejunal catheter; Patients who received a nasojejunal catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Follow up patients after undergoing operation up to 30 days	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay in both groups	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality due to surgical complications	30 day

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Director: Maria Isabel TD Correia, MD, PhD, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): July 10, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Gastrointestinal surgery, complications, length of hospital stay, mortality
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 301/08