Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

June 13, 2020 updated by: Ali GUNER, Karadeniz Technical University
We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

Study Type

Observational

Enrollment (Actual)

185

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
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University, Faculty of Medicine

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients undergoing surgery due to gastric cancer will be included in this study.

Description

Inclusion Criteria:

  1. Patients undergoing gastric surgery for gastric cancer
  2. Histologically proven gastric adenocarcinoma
  3. Patients over 18 years
  4. Patients who agreed to participate in the study

Exclusion Criteria:

  1. patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
  2. patients received palliative surgery without gastric resection (bypass procedures)
  3. patients required thoracotomy/thoracoscopy

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
Intervention / Treatment
Participants with gastric cancer
All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
Other: No intervention
No intervention is planned for the participants for the treatment of gastric cancer. Treatment decision will be in line with clinical practice guidelines. Surgical team will be blind to the participant's sarcopenia status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: within 30 days after surgery
complications graded by Clavien-Dindo Complication Classification System
within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: up to 90 days
time interval from the date of operation to the date of discharge
up to 90 days
Mortality
Time Frame: within 30 days after surgery
Dying after surgery
within 30 days after surgery
Readmission rate
Time Frame: within 30 days after surgery
readmission to the hospital because of the adverse events after discharge
within 30 days after surgery
Incidence of sarcopenia
Time Frame: one day before surgery
Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People
one day before surgery
Muscle mass volume
Time Frame: one day before surgery
muscle mass volume of a cross-sectional computerized- tomography image of the L3, corrected for patient height resulting in L3 muscle index.
one day before surgery
Psoas muscle mass volume
Time Frame: one day before surgery
muscle mass volume of Psoas muscle with 3D reconstruction
one day before surgery
Muscle strength
Time Frame: one day before surgery
evaluated by handgrip strength test (with digital dynamometer)
one day before surgery
Physical performance
Time Frame: one day before surgery
evaluated by 4-meter gait speed test
one day before surgery
Major complication
Time Frame: within 30 days after surgery
grade 3 or higher complications graded by Clavien-Dindo Complication Classification System
within 30 days after surgery

Collaborators and Investigators

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

Sponsor

Karadeniz Technical University

Investigators

  • Principal Investigator: Ali Guner, MD, Karadeniz Technical University Faculty of Medicine

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)

December 3, 2016

Primary Completion (Actual)

May 10, 2020

Study Completion (Actual)

June 10, 2020

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sarcopenia01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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