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

Primary Purpose

Early Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Approach Method
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Multi-port laparoscopic distal gastrectomy

Single incision distal gastrectomy

Arm Description

Laparoscopic distal gastrectomy using the conventional 5-port access

Pure single incision distal gastrectomy using one transumbilical incision

Outcomes

Primary Outcome Measures

Maximum pain score using VAS at postoperative day#1
Maximum postoperative pain using the visual analogue scale

Secondary Outcome Measures

Operation time
Time spent during operation
Estimated blood loss
Amount of blood loss during operation
Early postoperative complication
Postoperative complications within 30 days from the operation
Hospital stay
Days until discharge
Time to first flatus
Days until first flatus
Time to first soft fluid diet
Days until first soft fluid diet
Maximum pain scores using VAS
Maximum pain scores using the visual analogue scale
EORTC-C30 and STO22
Quality of life questionnaires

Full Information

First Posted
July 15, 2012
Last Updated
September 1, 2022
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01938326
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
Stomach neoplasm, TLDG, SIDG, single-port, inflammatory response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-port laparoscopic distal gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic distal gastrectomy using the conventional 5-port access
Arm Title
Single incision distal gastrectomy
Arm Type
Active Comparator
Arm Description
Pure single incision distal gastrectomy using one transumbilical incision
Intervention Type
Procedure
Intervention Name(s)
Approach Method
Intervention Description
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)
Primary Outcome Measure Information:
Title
Maximum pain score using VAS at postoperative day#1
Description
Maximum postoperative pain using the visual analogue scale
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Operation time
Description
Time spent during operation
Time Frame
Time during operation
Title
Estimated blood loss
Description
Amount of blood loss during operation
Time Frame
During operation
Title
Early postoperative complication
Description
Postoperative complications within 30 days from the operation
Time Frame
within 30 days from the operation
Title
Hospital stay
Description
Days until discharge
Time Frame
Days until discharge
Title
Time to first flatus
Description
Days until first flatus
Time Frame
Days until first flatus
Title
Time to first soft fluid diet
Description
Days until first soft fluid diet
Time Frame
Days until first soft fluid diet
Title
Maximum pain scores using VAS
Description
Maximum pain scores using the visual analogue scale
Time Frame
From postoperative day 0 to 5
Title
EORTC-C30 and STO22
Description
Quality of life questionnaires
Time Frame
Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hoon Ahn, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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