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Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
| 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 |
| Actual Enrollment : | 185 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 |
| Actual Primary Completion Date : | May 10, 2020 |
| Actual Study Completion Date : | June 10, 2020 |
| 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.
|
- 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
| 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 |
Inclusion Criteria:
- Patients undergoing gastric surgery for gastric cancer
- Histologically proven gastric adenocarcinoma
- Patients over 18 years
- Patients who agreed to participate in the study
Exclusion Criteria:
- patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
- patients received palliative surgery without gastric resection (bypass procedures)
- patients required thoracotomy/thoracoscopy
| Turkey | |
| Karadeniz Technical University, Faculty of Medicine | |
| Trabzon, Turkey, 61080 | |
| Principal Investigator: | Ali GUNER, MD | Karadeniz Technical University Faculty of Medicine |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 18, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | June 16, 2020 | ||||
| Actual Study Start Date | December 3, 2016 | ||||
| Actual Primary Completion Date | May 10, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Postoperative complications [ Time Frame: within 30 days after surgery ] complications graded by Clavien-Dindo Complication Classification System
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer | ||||
| Official Title | Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer | ||||
| Brief Summary | We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer | ||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All consecutive patients undergoing surgery due to gastric cancer will be included in this study. | ||||
| Condition |
|
||||
| Intervention | 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.
|
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| Study Groups/Cohorts | Participants with gastric cancer
All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
Intervention: Other: No intervention
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
185 | ||||
| Original Estimated Enrollment |
187 | ||||
| Actual Study Completion Date | June 10, 2020 | ||||
| Actual Primary Completion Date | May 10, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958032 | ||||
| Other Study ID Numbers | sarcopenia01 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ali GUNER, Karadeniz Technical University | ||||
| Study Sponsor | Karadeniz Technical University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Karadeniz Technical University | ||||
| Verification Date | June 2020 | ||||
