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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01073046
Other study ID # 1053222
Secondary ID
Status Completed
Phase N/A
First received February 1, 2010
Last updated August 1, 2012
Start date January 2010
Est. completion date June 2012

Study information

Verified date January 2010
Source Catholic University, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 276
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- People undergoing enteral nutrition through naso-jejunal tube

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Naso-Gastric/Jejunal Tube
Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)

Locations

Country Name City State
Italy Digestive Surgery, Catholic University Rome

Sponsors (2)

Lead Sponsor Collaborator
Catholic University, Italy Italian Research Group For Gastric Cancer - IRGGC

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Influence of Naso-Gastric/Jejunal Tube on Postoperative complications 2 years Yes
Secondary Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort 2 years Yes
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