Clinical trial NCT03958032: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Sarcopenia
Malnutrition; Cachexia
Complication
Keywords: sarcopenia
cancer
gastrointestinal
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing surgery due to gastric cancer will be included in this study.

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.

Eligibility 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

Primary outcomes:
measure: Postoperative complications
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 90 days
measure: Mortality
timeFrame: within 30 days after surgery
measure: Readmission rate
timeFrame: within 30 days after surgery
measure: Incidence of sarcopenia
timeFrame: one day before surgery
measure: Muscle mass volume
timeFrame: one day before surgery
measure: Psoas muscle mass volume
timeFrame: one day before surgery
measure: Muscle strength
timeFrame: one day before surgery
measure: Physical performance
timeFrame: one day before surgery
measure: Major complication
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University, Faculty of Medicine
Study officials:
affiliation: Karadeniz Technical University Faculty of Medicine
name: Ali GUNER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
citation: Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25.
citation: Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31.
citation: Guner A. Recent trends of gastric cancer treatment in Turkey. Transl Gastroenterol Hepatol. 2017 Apr 26;2:31. doi: 10.21037/tgh.2017.04.01. eCollection 2017.