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Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Completed
CT.gov ID
NCT01894490
Collaborator
(none)
50
Enrollment
1
Location
59
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy as a Route For Nutrition After Major Upper Gastrointestinal Operations
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Jejunostomy

    Patients who received a jejunostomy
    Nasojejunal catheter

    Patients who received a nasojejunal catheter

    Outcome Measures

    Primary Outcome Measures

    1. Complications [30 day]

      Follow up patients after undergoing operation up to 30 days

    Secondary Outcome Measures

    1. Length of hospital stay [30 days]

      Length of hospital stay in both groups

    Other Outcome Measures

    1. Mortality [30 day]

      Mortality due to surgical complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age over 18,

    • gastrointestinal resections

    Exclusion Criteria:

    • age under 18,

    • no gastrointestinal procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais Brazil 30130-100

    Sponsors and Collaborators

    • Federal University of Minas Gerais

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Isabel Toulson Davisson Correia, MD, PhD, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT01894490
    Other Study ID Numbers:
    • 301/08
    First Posted:
    Jul 10, 2013
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Maria Isabel Toulson Davisson Correia, MD, PhD, Federal University of Minas Gerais
    Gastrointestinal surgery, complications, length of hospital stay, mortality
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of Jul 10, 2013