Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)
Conditions
Early Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Approach Method
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- clinically early gastric cancer, potentially possible to perform distal gastrectomy

- 20< Age < 80

- No severe comorbidity

- No other malignancy

- No Other cancer treatments

- BMI < 23 in man, BMI < 25 in woman

Exclusion Criteria:

- Other reconstruction method except Billroth I
Location
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Status: Recruiting
Contact: Hyung-Ho Kim, M.D, Ph.D. - +82-31-787-7097 - hhkim@snubh.org
Start Date
July 2012
Completion Date
December 2014
Sponsors
Seoul National University Bundang Hospital
Source
Seoul National University Bundang Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page