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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738478
• Other study ID #: WMC-RCTGastric01
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2008
• Last updated: February 17, 2009
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• nasogastric tube
insertion of nasogastric tube for 2 days after operation
• without nasogastric tube
without nasogastric tube after operation

Locations

Country	Name	City	State
Japan	Second Department of Surgery, Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		seven days after operation	Yes
Secondary	complication, hematological data,		the time of discharge	Yes