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aparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial

Phase 3
Conditions
Early gastric cancer
Registration Number
JPRN-UMIN000001513
Lead Sponsor
Kitasato University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria were past history of gastric cancer, having received open surgery of the upper abdomen, past history of other types of cancers and cancer treatmentd, serious heart, lung, kidney, blood and/or metabolic diseases, Class III or IV of the New York Heart Association classification of cardiac patients, and Class III of Hugh-Jones dyspnea criteria.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The short term primary outcome measure was defined as the intensity of post-operative use of analgesics. Long term primary outcome was overall survival.
Secondary Outcome Measures
NameTimeMethod
Short term secondary outcomes were intraoperative and postoperative complication rates, days of post-operative hospitalization, and post-operative inconveniences such as days of fever (> 37 degrees Celsius), days to first flatus, VAS pain scores, and blood loss.
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