Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 5:24 AM
Study NCT ID:
NCT03958032
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2019-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-13', 'studyFirstSubmitDate': '2019-05-18', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'within 30 days after surgery', 'description': 'complications graded by Clavien-Dindo Complication Classification System'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'up to 90 days', 'description': 'time interval from the date of operation to the date of discharge'}, {'measure': 'Mortality', 'timeFrame': 'within 30 days after surgery', 'description': 'Dying after surgery'}, {'measure': 'Readmission rate', 'timeFrame': 'within 30 days after surgery', 'description': 'readmission to the hospital because of the adverse events after discharge'}, {'measure': 'Incidence of sarcopenia', 'timeFrame': 'one day before surgery', 'description': 'Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People'}, {'measure': 'Muscle mass volume', 'timeFrame': 'one day before surgery', 'description': 'muscle mass volume of a cross-sectional computerized- tomography image of the L3, corrected for patient height resulting in L3 muscle index.'}, {'measure': 'Psoas muscle mass volume', 'timeFrame': 'one day before surgery', 'description': 'muscle mass volume of Psoas muscle with 3D reconstruction'}, {'measure': 'Muscle strength', 'timeFrame': 'one day before surgery', 'description': 'evaluated by handgrip strength test (with digital dynamometer)'}, {'measure': 'Physical performance', 'timeFrame': 'one day before surgery', 'description': 'evaluated by 4-meter gait speed test'}, {'measure': 'Major complication', 'timeFrame': 'within 30 days after surgery', 'description': 'grade 3 or higher complications graded by Clavien-Dindo Complication Classification System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'cancer', 'gastrointestinal'], 'conditions': ['Gastric Cancer', 'Sarcopenia', 'Malnutrition; Cachexia', 'Complication']}, 'referencesModule': {'references': [{'pmid': '20392703', 'type': 'BACKGROUND', '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.'}, {'pmid': '26407875', 'type': 'BACKGROUND', '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.'}, {'pmid': '26331988', 'type': 'BACKGROUND', '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.'}, {'pmid': '28529985', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer', 'detailedDescription': '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.\n\nSarcopenia 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients undergoing surgery due to gastric cancer will be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing gastric surgery for gastric cancer\n2. Histologically proven gastric adenocarcinoma\n3. Patients over 18 years\n4. Patients who agreed to participate in the study\n\nExclusion Criteria:\n\n1. patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)\n2. patients received palliative surgery without gastric resection (bypass procedures)\n3. patients required thoracotomy/thoracoscopy'}, 'identificationModule': {'nctId': 'NCT03958032', 'briefTitle': 'Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer', 'orgStudyIdInfo': {'id': 'sarcopenia01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with gastric cancer', 'description': 'All consecutive patients undergoing surgery due to gastric cancer will be included in this study.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Participants with gastric cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University, Faculty of Medicine', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Ali GUNER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ali GUNER', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}