Early Gastric Cancer Clinical Trial
Official title:
Postoperative Pain and Quality of Life After Single-incision Distal Gastrectomy Versus Totally Laparoscopic Distal Gastrectomy for Early Gastric Cancer - a Randomized Controlled Trial
Verified date | September 2022 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
1. Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC) 2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)
Status | Completed |
Enrollment | 86 |
Est. completion date | April 30, 2020 |
Est. primary completion date | February 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds) - 20< Age < 80 Exclusion Criteria - history of other malignancy - received preoperative chemotherapy |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum pain score using VAS at postoperative day#1 | Maximum postoperative pain using the visual analogue scale | Postoperative day 1 | |
Secondary | Operation time | Time spent during operation | Time during operation | |
Secondary | Estimated blood loss | Amount of blood loss during operation | During operation | |
Secondary | Early postoperative complication | Postoperative complications within 30 days from the operation | within 30 days from the operation | |
Secondary | Hospital stay | Days until discharge | Days until discharge | |
Secondary | Time to first flatus | Days until first flatus | Days until first flatus | |
Secondary | Time to first soft fluid diet | Days until first soft fluid diet | Days until first soft fluid diet | |
Secondary | Maximum pain scores using VAS | Maximum pain scores using the visual analogue scale | From postoperative day 0 to 5 | |
Secondary | EORTC-C30 and STO22 | Quality of life questionnaires | Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery |
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