Clinical trial NCT01938326: Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Keywords: Stomach neoplasm
TLDG
SIDG
single-port
inflammatory response
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum pain score using VAS at postoperative day#1
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Operation time
timeFrame: Time during operation
measure: Estimated blood loss
timeFrame: During operation
measure: Early postoperative complication
timeFrame: within 30 days from the operation
measure: Hospital stay
timeFrame: Days until discharge
measure: Time to first flatus
timeFrame: Days until first flatus
measure: Time to first soft fluid diet
timeFrame: Days until first soft fluid diet
measure: Maximum pain scores using VAS
timeFrame: From postoperative day 0 to 5
measure: EORTC-C30 and STO22
timeFrame: Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang-Hoon Ahn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: