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

Not Applicable

Completed

• Conditions: Early Gastric Cancer
• Interventions: Procedure: Approach Method

• Registration Number: NCT01938326
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2012-07-15
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Study Start: 2017-09-01
• Primary Completion: 2020-02-27
• Study Completion: 2020-04-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single incision distal gastrectomy	Approach Method	Pure single incision distal gastrectomy using one transumbilical incision
Multi-port laparoscopic distal gastrectomy	Approach Method	Laparoscopic distal gastrectomy using the conventional 5-port access

Primary Outcome Measures

Name	Time	Method
Maximum pain score using VAS at postoperative day#1	Postoperative day 1	Maximum postoperative pain using the visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Operation time	Time during operation	Time spent during operation
Hospital stay	Days until discharge	Days until discharge
Maximum pain scores using VAS	From postoperative day 0 to 5	Maximum pain scores using the visual analogue scale
Early postoperative complication	within 30 days from the operation	Postoperative complications within 30 days from the operation
Time to first flatus	Days until first flatus	Days until first flatus
Estimated blood loss	During operation	Amount of blood loss during operation
Time to first soft fluid diet	Days until first soft fluid diet	Days until first soft fluid diet
EORTC-C30 and STO22	Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery	Quality of life questionnaires

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of