NCT00738478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

August 19, 2008

Last Update Submit

February 17, 2009

Conditions

Gastric Cancer

Keywords

distal gastrectomyquality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    seven days after operation

Secondary Outcomes (1)

  • complication, hematological data,

    the time of discharge

Study Arms (2)

A

EXPERIMENTAL

Arm A: with nasogastric tube

Device: nasogastric tube

B

ACTIVE COMPARATOR

Arm B: without nasogastric tube

Device: without nasogastric tube

Interventions

nasogastric tubeDEVICE

insertion of nasogastric tube for 2 days after operation

A
without nasogastric tubeDEVICE

without nasogastric tube after operation

B

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Surgery, Wakayama Medical University

Wakayama, 641-8510, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Mikihito Nakamori, MD

    Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

JP(1)