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Clinical Trial Summary

The present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.


Clinical Trial Description

The primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery. Early postoperative morbidity is classified as follows: (1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc. The secondary end point is the questionnaire score regarding QOL. This is assessed by the Korean versions of the EORTC QLQ-C30 (version 3.0) and STO22 questionnaires. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03393182
Study type Interventional
Source Korea University Anam Hospital
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date February 18, 2022

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