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

This study has been completed.
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00738478
First received: August 19, 2008
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Device: nasogastric tube
Device: without nasogastric tube
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study for the Significance of Nasogastric Decompression Tube After Curative Distal Gastrectomy for Gastric Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Quality of life [ Time Frame: seven days after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complication, hematological data, [ Time Frame: the time of discharge ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Arm A: with nasogastric tube
 Device: nasogastric tube
insertion of nasogastric tube for 2 days after operation
Active Comparator: B
Arm B: without nasogastric tube
 Device: without nasogastric tube
without nasogastric tube after operation

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738478

Locations
Japan
Second Department of Surgery, Wakayama Medical University
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Principal Investigator: Mikihito Nakamori, MD Wakayama Medical University
  More Information

No publications provided

Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00738478     History of Changes
Other Study ID Numbers: WMC-RCTGastric01
Study First Received: August 19, 2008
Last Updated: February 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
distal gastrectomy
quality of life

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 17, 2013