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Gastric Decompression After Sub-total Gastrectomy

NCT ID: NCT01073046

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Gastric Cancer

Keywords

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Naso-Gastric/Jejunal Tube Sub-total Gastrectomy Gastric Cancer Decompression Discomfort Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Place Naso-Gastric/Jejunal Tube Group

In this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl)

Naso-Gastric/Jejunal Tube

Intervention Type DEVICE

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

No Naso-Gastric/Jejunal Tube Group

In this group a silastic naso-gastric/jejunal tube is not placed

No interventions assigned to this group

Interventions

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Naso-Gastric/Jejunal Tube

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

Intervention Type DEVICE

Other Intervention Names

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Rusch® distributed by Teleflex Medical Srl

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* People undergoing enteral nutrition through naso-jejunal tube
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Research Group For Gastric Cancer - IRGGC

UNKNOWN

Sponsor Role collaborator

Catholic University, Italy

OTHER

Sponsor Role lead

Responsible Party

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Fausto Rosa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Surgery, Catholic University

Rome, , Italy

Site Status

Countries

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Italy

References

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Pacelli F, Rosa F, Marrelli D, Morgagni P, Framarini M, Cristadoro L, Pedrazzani C, Casadei R, Cozzaglio L, Covino M, Donini A, Roviello F, de Manzoni G, Doglietto GB. Naso-gastric or naso-jejunal decompression after partial distal gastrectomy for gastric cancer. Final results of a multicenter prospective randomized trial. Gastric Cancer. 2014 Oct;17(4):725-32. doi: 10.1007/s10120-013-0319-x. Epub 2013 Nov 30.

Reference Type DERIVED
PMID: 24292257 (View on PubMed)

Other Identifiers

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1053222

Identifier Type: -

Identifier Source: org_study_id