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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
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)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Maximum pain score using VAS at postoperative day#1
Maximum postoperative pain using the visual analogue scale
Time frame: Postoperative day 1
Operation time
Time spent during operation
Time frame: Time during operation
Estimated blood loss
Amount of blood loss during operation
Time frame: During operation
Early postoperative complication
Postoperative complications within 30 days from the operation
Time frame: within 30 days from the operation
Hospital stay
Days until discharge
Time frame: Days until discharge
Time to first flatus
Days until first flatus
Time frame: Days until first flatus
Time to first soft fluid diet
Days until first soft fluid diet
Time frame: Days until first soft fluid diet
Maximum pain scores using VAS
Maximum pain scores using the visual analogue scale
Time frame: From postoperative day 0 to 5
EORTC-C30 and STO22
Quality of life questionnaires
Time frame: Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery
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