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

Seoul National University

Status: Completed

Conditions: Early Gastric Cancer

Treatments: Procedure: Approach Method

Study type: Interventional

Funder types: Other

Identifiers

NCT01938326

SNUBH-SIDG-GS-PII

Details and patient eligibility

About

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)

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Multi-port laparoscopic distal gastrectomy

Active Comparator group

Description:

Laparoscopic distal gastrectomy using the conventional 5-port access

Treatment:

Procedure: Approach Method

Single incision distal gastrectomy

Active Comparator group

Description:

Pure single incision distal gastrectomy using one transumbilical incision

Treatment:

Procedure: Approach Method