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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

August 19, 2008
February 17, 2009
February 2006
December 2008   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: seven days after operation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00738478 on ClinicalTrials.gov Archive Site
complication, hematological data, [ Time Frame: the time of discharge ] [ Designated as safety issue: Yes ]
copmlication, hematological data, [ Time Frame: the time of discharge ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients
Phase III Study for the Significance of Nasogastric Decompression Tube After Curative Distal Gastrectomy for Gastric Cancer Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Device: nasogastric tube
    insertion of nasogastric tube for 2 days after operation
  • Device: without nasogastric tube
    without nasogastric tube after operation
  • Experimental: A
    Arm A: with nasogastric tube
    Intervention: Device: nasogastric tube
  • Active Comparator: B
    Arm B: without nasogastric tube
    Intervention: Device: without nasogastric tube
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00738478
WMC-RCTGastric01
Yes
Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
Not Provided
Principal Investigator: Mikihito Nakamori, MD Wakayama Medical University
Wakayama Medical University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP