NCT01938326

Brief Summary

  1. 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. 2.Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 years until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

July 15, 2012

Last Update Submit

September 1, 2022

Conditions

Early Gastric Cancer

Keywords

Stomach neoplasmTLDGSIDGsingle-portinflammatory response

Outcome Measures

Primary Outcomes (1)

  • Maximum pain score using VAS at postoperative day#1

    Maximum postoperative pain using the visual analogue scale

    Postoperative day 1

Secondary Outcomes (8)

  • Operation time

    Time during operation

  • Estimated blood loss

    During operation

  • Early postoperative complication

    within 30 days from the operation

  • Hospital stay

    Days until discharge

  • Time to first flatus

    Days until first flatus

  • +3 more secondary outcomes

Study Arms (2)

Multi-port laparoscopic distal gastrectomy

ACTIVE COMPARATOR

Laparoscopic distal gastrectomy using the conventional 5-port access

Procedure: Approach Method

Single incision distal gastrectomy

ACTIVE COMPARATOR

Pure single incision distal gastrectomy using one transumbilical incision

Procedure: Approach Method

Interventions

Approach MethodPROCEDURE

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)

Multi-port laparoscopic distal gastrectomySingle incision distal gastrectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
  • \< Age \< 80

You may not qualify if:

  • history of other malignancy
  • received preoperative chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Sang-Hoon Ahn, M.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2012

First Posted

September 10, 2013

Study Start

September 1, 2017

Primary Completion

February 27, 2020

Study Completion

April 30, 2020

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

KR(1)