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

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ClinicalTrials.gov Identifier: NCT03958032
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ali GUNER, Karadeniz Technical University

Brief Summary:
We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Condition or disease Intervention/treatment
Gastric Cancer Sarcopenia Malnutrition; Cachexia Complication Other: No intervention

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.


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Study Type : Observational
Estimated Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
Actual Study Start Date : December 3, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: within 30 days after surgery ]
    complications graded by Clavien-Dindo Complication Classification System


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: up to 90 days ]
    time interval from the date of operation to the date of discharge

  2. Mortality [ Time Frame: within 30 days after surgery ]
    Dying after surgery

  3. Readmission rate [ Time Frame: within 30 days after surgery ]
    readmission to the hospital because of the adverse events after discharge

  4. Incidence of sarcopenia [ Time Frame: one day before surgery ]
    Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People

  5. 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.

  6. Psoas muscle mass volume [ Time Frame: one day before surgery ]
    muscle mass volume of Psoas muscle with 3D reconstruction

  7. Muscle strength [ Time Frame: one day before surgery ]
    evaluated by handgrip strength test (with digital dynamometer)

  8. Physical performance [ Time Frame: one day before surgery ]
    evaluated by 4-meter gait speed test

  9. Major complication [ Time Frame: within 30 days after surgery ]
    grade 3 or higher complications graded by Clavien-Dindo Complication Classification System



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958032


Contacts
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Contact: Ali GUNER, MD 904623775439 draliguner@yahoo.com
Contact: Reyyan Yildirim, MD 905368424127 reyyanymd@gmail.com

Locations
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Turkey
Karadeniz Technical University, Faculty of Medicine Recruiting
Trabzon, Turkey, 61080
Contact: Ali GUNER, MD    904623775439    draliguner@yahoo.com   
Contact: Oğuz Erkul, MD    905516213060    oguz_erkul@windowslive.com   
Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Principal Investigator: Ali GUNER, MD Karadeniz Technical University Faculty of Medicine

Publications:
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Responsible Party: Ali GUNER, Associate Professor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT03958032     History of Changes
Other Study ID Numbers: sarcopenia01
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali GUNER, Karadeniz Technical University:
sarcopenia
cancer
gastrointestinal
Additional relevant MeSH terms:
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Stomach Neoplasms
Sarcopenia
Malnutrition
Cachexia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight