Gastric Decompression After Sub-total Gastrectomy

This study has been completed.
Sponsor:
Collaborator:
Italian Research Group For Gastric Cancer - IRGGC
Information provided by (Responsible Party):
Fausto Rosa, Catholic University, Italy
ClinicalTrials.gov Identifier:
NCT01073046
First received: February 1, 2010
Last updated: August 1, 2012
Last verified: January 2010
  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 Catholic University, Italy:

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

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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fausto Rosa, MD, Catholic University, Italy
ClinicalTrials.gov Identifier: NCT01073046     History of Changes
Other Study ID Numbers: 1053222
Study First Received: February 1, 2010
Last Updated: August 1, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014