Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

Postoperative Complications After Gastrointestinal Operations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894490
• Other study ID #: 301/08
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: July 9, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18,

• gastrointestinal resections

Exclusion Criteria:

• age under 18,

• no gastrointestinal procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative Complications
• Postoperative Complications After Gastrointestinal Operations

Locations

Country	Name	City	State
Brazil	Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Mortality due to surgical complications	30 day	No
Primary	Complications	Follow up patients after undergoing operation up to 30 days	30 day	No
Secondary	Length of hospital stay	Length of hospital stay in both groups	30 days	No