Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

July 20, 2020 updated by: Adem Yuksel, Kocaeli Derince Education and Research Hospital

Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Derince
      • Kocasinan, Derince, Turkey, 41900
        • Kocaeli Derince Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
open gastrectomy
The first group (Group 1; n: 30) consisted of patients who underwent open surgery
Procedure: gastrectomy
gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
laparoscopic gastrectomy
The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy
Procedure: gastrectomy
gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 2014-2019
year
2014-2019
Body mass index
Time Frame: 2014- 2019
kg/m2
2014- 2019
Previous abdominal surgery status
Time Frame: 2014-2019
yes or no
2014-2019
Comorbidity status
Time Frame: 2014 -2019
present or absent
2014 -2019
Neoadjuvant therapy status
Time Frame: 2014-2019
present or absent
2014-2019
American Society of Anesthesiologists (ASA) score
Time Frame: 2014-2019
1,2,3,4
2014-2019
Gender
Time Frame: 2014-2019
male or female
2014-2019
Surgical technique
Time Frame: 2014-2019
open or laparoscopic
2014-2019
Tumor localization
Time Frame: 2014 - 2019
proximal, middle, lower
2014 - 2019
Gastrectomy type
Time Frame: 2014 - 2019
total, subtotal
2014 - 2019
Lymph node dissection type
Time Frame: 2014 - 2019
D1+, D2
2014 - 2019
Operation time
Time Frame: 2014 - 2019
minute
2014 - 2019
Blood loss
Time Frame: 2014 - 2019
ml
2014 - 2019
Complication (Clavien-Dindo Classification)
Time Frame: 2014 - 2019
1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)
2014 - 2019
30-day mortality
Time Frame: 2014 - 2019
present or absent
2014 - 2019
Number of harvested lymph node
Time Frame: 2014 - 2019
number
2014 - 2019
Resection margin status
Time Frame: 2014 - 2019
positive or negative
2014 - 2019
Tumor stage (American Joint Committee on Cancer 8th Edition)
Time Frame: 2014 - 2019
0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)
2014 - 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli Derince Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-98

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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