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NCT01938326 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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