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
|Condition or disease||Intervention/treatment|
|Gastric Cancer Sarcopenia Malnutrition; Cachexia Complication||Other: No intervention|
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|
|Estimated Enrollment :||187 participants|
|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|
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.
- Postoperative complications [ Time Frame: within 30 days after surgery ]complications graded by Clavien-Dindo Complication Classification System
- Length of hospital stay [ Time Frame: up to 90 days ]time interval from the date of operation to the date of discharge
- Mortality [ Time Frame: within 30 days after surgery ]Dying after surgery
- Readmission rate [ Time Frame: within 30 days after surgery ]readmission to the hospital because of the adverse events after discharge
- Incidence of sarcopenia [ Time Frame: one day before surgery ]Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People
- 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.
- Psoas muscle mass volume [ Time Frame: one day before surgery ]muscle mass volume of Psoas muscle with 3D reconstruction
- Muscle strength [ Time Frame: one day before surgery ]evaluated by handgrip strength test (with digital dynamometer)
- Physical performance [ Time Frame: one day before surgery ]evaluated by 4-meter gait speed test
- Major complication [ Time Frame: within 30 days after surgery ]grade 3 or higher complications graded by Clavien-Dindo Complication Classification System
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
|Contact: Ali GUNER, MDfirstname.lastname@example.org|
|Contact: Reyyan Yildirim, MDemail@example.com|
|Karadeniz Technical University, Faculty of Medicine||Recruiting|
|Trabzon, Turkey, 61080|
|Contact: Ali GUNER, MD 904623775439 firstname.lastname@example.org|
|Contact: Oğuz Erkul, MD 905516213060 email@example.com|
|Principal Investigator:||Ali GUNER, MD||Karadeniz Technical University Faculty of Medicine|