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

NCT ID: NCT00738478

Last Updated: 2009-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Arm A: with nasogastric tube

Group Type: EXPERIMENTAL

nasogastric tube

Intervention Type: DEVICE

insertion of nasogastric tube for 2 days after operation

B

Arm B: without nasogastric tube

Group Type: ACTIVE_COMPARATOR

without nasogastric tube

Intervention Type: DEVICE

without nasogastric tube after operation

Interventions

nasogastric tube

insertion of nasogastric tube for 2 days after operation

Intervention Type: DEVICE

without nasogastric tube

without nasogastric tube after operation

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wakayama Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wakayama Medical University

Principal Investigators

Mikihito Nakamori, MD

Role: PRINCIPAL_INVESTIGATOR

Wakayama Medical University

Locations

Second Department of Surgery, Wakayama Medical University

Wakayama, , Japan

Countries

Japan

Other Identifiers

WMC-RCTGastric01

Identifier Type: -

Identifier Source: org_study_id