Gastric Decompression After Sub-total Gastrectomy
Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial
1 other identifier
observational
276
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 2, 2012
January 1, 2010
2.4 years
February 1, 2010
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Influence of Naso-Gastric/Jejunal Tube on Postoperative complications
2 years
Secondary Outcomes (1)
Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort
2 years
Study Arms (2)
Place Naso-Gastric/Jejunal Tube Group
In this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl)
No Naso-Gastric/Jejunal Tube Group
In this group a silastic naso-gastric/jejunal tube is not placed
Interventions
Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)
Eligibility Criteria
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.
You may qualify if:
- All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.
You may not qualify if:
- People undergoing enteral nutrition through naso-jejunal tube
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Surgery, Catholic University
Rome, 00168, Italy
Related Publications (1)
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.
PMID: 24292257DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 23, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 2, 2012
Record last verified: 2010-01