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Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

nasogastric tube

without nasogastric tube

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring distal gastrectomy, quality of life

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

on the basis of whether distal gastrectomy was anticipated at WMUH for gastric cancer.

Exclusion Criteria:

patients who were diagnosed inadequacy for this study by a physician.
patients without an informed consent.

Sites / Locations

Second Department of Surgery, Wakayama Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Arm A: with nasogastric tube

Arm B: without nasogastric tube

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

complication, hematological data,

Full Information

NCT ID

NCT00738478

First Posted

August 19, 2008

Last Updated

February 17, 2009

Sponsor

Wakayama Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00738478

Brief Title

Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients

Official Title

Phase III Study for the Significance of Nasogastric Decompression Tube After Curative Distal Gastrectomy for Gastric Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wakayama Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of the study is to evaluate whether distal gastrectomy without post-operative nasogastric decompression tube is better in terms of quality of life.

Detailed Description

Nasogastric decompression tube is an intra-operative routine in most of the time to facilitate exposure of operative field during elective distal gastrectomy, however, whether it should be retained post-operatively is controversial. Nasogastric decompression tube helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. However, nasogastric intubation could cause patients discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with pulmonary complication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

distal gastrectomy, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm A: with nasogastric tube

Arm Title

Arm Type

Active Comparator

Arm Description

Arm B: without nasogastric tube

Intervention Type

Device

Intervention Name(s)

nasogastric tube

Intervention Description

insertion of nasogastric tube for 2 days after operation

Intervention Type

Device

Intervention Name(s)

without nasogastric tube

Intervention Description

without nasogastric tube after operation

Primary Outcome Measure Information:

Title

Quality of life

Time Frame

seven days after operation

Secondary Outcome Measure Information:

Title

complication, hematological data,

Time Frame

the time of discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: on the basis of whether distal gastrectomy was anticipated at WMUH for gastric cancer. Exclusion Criteria: patients who were diagnosed inadequacy for this study by a physician. patients without an informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikihito Nakamori, MD

Organizational Affiliation

Wakayama Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second Department of Surgery, Wakayama Medical University

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

12. IPD Sharing Statement

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Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients

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