NCT04481828

Brief Summary

In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5.9 years

First QC Date

July 16, 2020

Last Update Submit

July 20, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (18)

  • Age

    year

    2014-2019

  • Body mass index

    kg/m2

    2014- 2019

  • Previous abdominal surgery status

    yes or no

    2014-2019

  • Comorbidity status

    present or absent

    2014 -2019

  • Neoadjuvant therapy status

    present or absent

    2014-2019

  • American Society of Anesthesiologists (ASA) score

    1,2,3,4

    2014-2019

  • Gender

    male or female

    2014-2019

  • Surgical technique

    open or laparoscopic

    2014-2019

  • Tumor localization

    proximal, middle, lower

    2014 - 2019

  • Gastrectomy type

    total, subtotal

    2014 - 2019

  • Lymph node dissection type

    D1+, D2

    2014 - 2019

  • Operation time

    minute

    2014 - 2019

  • Blood loss

    ml

    2014 - 2019

  • Complication (Clavien-Dindo Classification)

    1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)

    2014 - 2019

  • 30-day mortality

    present or absent

    2014 - 2019

  • Number of harvested lymph node

    number

    2014 - 2019

  • Resection margin status

    positive or negative

    2014 - 2019

  • Tumor stage (American Joint Committee on Cancer 8th Edition)

    0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)

    2014 - 2019

Study Arms (2)

open gastrectomy

The first group (Group 1; n: 30) consisted of patients who underwent open surgery

Procedure: gastrectomy

laparoscopic gastrectomy

The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy

Procedure: gastrectomy

Interventions

gastrectomyPROCEDURE

gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

laparoscopic gastrectomyopen gastrectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer.

You may qualify if:

  • Gastric cancer(adenocarcinoma) proven biopsy
  • Operated by same surgical team
  • Presence of distant metastasis

You may not qualify if:

  • Patients who underwent palliative resection
  • operated by a different surgical team
  • ASA score: 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Training and research Hospital

Kocasinan, Derince, 41900, Turkey (Türkiye)

Location

Related Publications (3)

  • Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.

    PMID: 27401443BACKGROUND

  • van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.

    PMID: 28730391BACKGROUND

  • Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.

    PMID: 26603678BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Department of Gastroenterological surgery,Principal Investigator

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 22, 2020

Study Start

January 1, 2014

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

TU(1)