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Gastric Decompression After Sub-total Gastrectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073046
First Posted: February 23, 2010
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Italian Research Group For Gastric Cancer - IRGGC
Information provided by (Responsible Party):
Fausto Rosa, Catholic University, Italy
  Purpose
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.

Condition Intervention
Gastric Cancer Device: Naso-Gastric/Jejunal Tube

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Fausto Rosa, Catholic University, Italy:

Primary Outcome Measures:
  • Influence of Naso-Gastric/Jejunal Tube on Postoperative complications [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort [ Time Frame: 2 years ]

Enrollment: 276
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Rusch® distributed by Teleflex Medical Srl
No Naso-Gastric/Jejunal Tube Group
In this group a silastic naso-gastric/jejunal tube is not placed

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • People undergoing enteral nutrition through naso-jejunal tube
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073046


Locations
Italy
Digestive Surgery, Catholic University
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University, Italy
Italian Research Group For Gastric Cancer - IRGGC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fausto Rosa, MD, Catholic University, Italy
ClinicalTrials.gov Identifier: NCT01073046     History of Changes
Other Study ID Numbers: 1053222
First Submitted: February 1, 2010
First Posted: February 23, 2010
Last Update Posted: August 2, 2012
Last Verified: January 2010

Keywords provided by Fausto Rosa, Catholic University, Italy:
Naso-Gastric/Jejunal Tube
Sub-total Gastrectomy
Gastric Cancer
Decompression
Discomfort
Complications

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases