Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)

Study Overview
=================
Brief Summary
-----------------
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) 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.

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

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Approach Method


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multi-port laparoscopic distal gastrectomy<br>Laparoscopic distal gastrectomy using the conventional 5-port access | Procedure: Approach Method<br>* 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)<br>|
| Active Comparator: Single incision distal gastrectomy<br>Pure single incision distal gastrectomy using one transumbilical incision | Procedure: Approach Method<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain score using VAS at postoperative day#1 | Maximum postoperative pain using the visual analogue scale | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Time spent during operation | Time during operation | 
| Estimated blood loss | Amount of blood loss during operation | During operation | 
| Early postoperative complication | Postoperative complications within 30 days from the operation | within 30 days from the operation | 
| Hospital stay | Days until discharge | Days until discharge | 
| 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 | Maximum pain scores using the visual analogue scale | From postoperative day 0 to 5 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response