Randomized Clinical Trial: Nasoenteric Catheter or Jejuno... | NCT01894490

Studies
Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

NCT01894490

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

Jul 10, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Postoperative Complications After Gastrointestinal Operations

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 4, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2013

Last Update Posted Date

Jul 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Isabel Toulson Davisson Correia, MD, PhD, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Jejunostomy		Patients who received a jejunostomy
Nasojejunal catheter		Patients who received a nasojejunal catheter

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18,
gastrointestinal resections

Exclusion Criteria:

age under 18,
no gastrointestinal procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with gastrointestinal disorders undergoing major abdominal operations

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Isabel TD Correia, MD, PhD	Federal University of Minas Gerais	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal de Minas Gerais		Belo Horizonte	Minas Gerais	30130-100	Brazil