NCT01894490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

3.9 years

First QC Date

July 4, 2013

Last Update Submit

July 9, 2013

Conditions

Postoperative Complications After Gastrointestinal Operations

Keywords

Gastrointestinal surgery, complications, length of hospital stay, mortality

Outcome Measures

Primary Outcomes (1)

  • Complications

    Follow up patients after undergoing operation up to 30 days

    30 day

Secondary Outcomes (1)

  • Length of hospital stay

    30 days

Other Outcomes (1)

  • Mortality

    30 day

Study Arms (2)

Jejunostomy

Patients who received a jejunostomy

Nasojejunal catheter

Patients who received a nasojejunal catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with gastrointestinal disorders undergoing major abdominal operations

You may qualify if:

  • age over 18,
  • gastrointestinal resections

You may not qualify if:

  • age under 18,
  • no gastrointestinal procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Study Officials

  • Maria Isabel TD Correia, MD, PhD

    Federal University of Minas Gerais

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

BR(1)