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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938326
• Other study ID #: SNUBH-SIDG-GS-PII
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 30, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Approach Method
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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain score using VAS at postoperative day#1	Maximum postoperative pain using the visual analogue scale	Postoperative day 1
Secondary	Operation time	Time spent during operation	Time during operation
Secondary	Estimated blood loss	Amount of blood loss during operation	During operation
Secondary	Early postoperative complication	Postoperative complications within 30 days from the operation	within 30 days from the operation
Secondary	Hospital stay	Days until discharge	Days until discharge
Secondary	Time to first flatus	Days until first flatus	Days until first flatus
Secondary	Time to first soft fluid diet	Days until first soft fluid diet	Days until first soft fluid diet
Secondary	Maximum pain scores using VAS	Maximum pain scores using the visual analogue scale	From postoperative day 0 to 5
Secondary	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