Early Gastric Cancer
Conditions
Keywords
Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response
Brief summary
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)
Detailed description
There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery. Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published. However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications. This study is planned as a phase II study. There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.
Interventions
PROCEDUREApproach Method
SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain score using VAS at postoperative day#1 | Postoperative day 1 | Maximum postoperative pain using the visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Time during operation | Time spent during operation |
| Estimated blood loss | During operation | Amount of blood loss during operation |
| Early postoperative complication | within 30 days from the operation | Postoperative complications within 30 days from the operation |
| EORTC-C30 and STO22 | Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery | Quality of life questionnaires |
| Time to first flatus | Days until first flatus | Days until first flatus |
| Time to first soft fluid diet | Days until first soft fluid diet | Days until first soft fluid diet |
| Maximum pain scores using VAS | From postoperative day 0 to 5 | Maximum pain scores using the visual analogue scale |
| Hospital stay | Days until discharge | Days until discharge |
Countries
South Korea
Outcome results
None listed