Gastric Decompression After Sub-total Gastrectomy

August 1, 2012 updated by: Fausto Rosa, Catholic University, Italy

Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial

The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Digestive Surgery, Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be included, using a randomization list provided to each center, in one of two groups:

  1. placement of a polyurethane nasogastric/jejunal tube, preferentially 12-14 Fr;
  2. no feeding tube placement.

Description

Inclusion Criteria:

  • All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.

Exclusion Criteria:

  • People undergoing enteral nutrition through naso-jejunal tube

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Place Naso-Gastric/Jejunal Tube Group
In this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl)
Device: Naso-Gastric/Jejunal Tube
Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)
Other Names:
  • Rusch® distributed by Teleflex Medical Srl
No Naso-Gastric/Jejunal Tube Group
In this group a silastic naso-gastric/jejunal tube is not placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of Naso-Gastric/Jejunal Tube on Postoperative complications
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University, Italy

Collaborators

Italian Research Group For Gastric Cancer - IRGGC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1053222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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