Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients - Full Text View

Sponsored by:	Wakayama Medical University
Information provided by:	Wakayama Medical University
ClinicalTrials.gov Identifier:	NCT00738478

Purpose

The aim of the study is to evaluated 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 III

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study for the Significance of Nasogastric Decompression Tube After Curative Distal Gastrectomy for Gastric Cancer Patients

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:

copmlication, hematological data, [ Time Frame: the time of discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2009
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Arm A: with nasogastric tube	Device: nasogastric tube insertion of nasogastric tube for 2 days after operation
B: Active Comparator 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 relieave 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 inadequency 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

Contacts

Contact: Mikihito Nakamori, MD

81-73-447-2300 ext 5110

chamcham@wakayama-med.ac.jp

Locations

Japan
Second Department of Surgery, Wakayama Medical University	Recruiting
Wakayama, Japan, 641-8510
Contact: Hiroki Yamaue, MD 073-447-2300 ext 5110 yamaue-h@wakayama-med.ac.jp
Principal Investigator: Mikihito Nakamori, MD

Sponsors and Collaborators

Wakayama Medical University

Investigators

Principal Investigator:

Mikihito Nakamori, MD

Wakayama Medical University

More Information

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

Keywords provided by Wakayama Medical University:

distal gastrectomy, quality of life

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Quality of Life
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009