Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062051) titled 'Prospective observational study of postoperative symptoms and nutritional status after upper gastrointestinal resection using a wearable chewing monitoring device' on July 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kindai University Nara Hospital
Condition:
Condition - Gastric cancer, esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to exploratorily evaluate the association between chewing behavior measured using a wearable chewing monitoring device (bitescan) and postoperative symptoms, quality of life, body weight change, and nutritional status after upper gastrointestinal resection for gastric or esophageal cancer.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients scheduled to undergo elective gastrectomy for gastric cancer or related diseases, or elective esophagectomy for esophageal cancer.
2.Patients aged 18 years or older.
3.Patients who are able to take food orally, understand the study, and provide written informed consent.
Key exclusion criteria - 1.Patients with severe dysphagia or those judged to be at high risk of aspiration and unable to safely consume the standardized test meal.
2.Patients with oral or temporomandibular joint disorders that may substantially affect chewing assessment.
3.Patients judged by the investigator to be inappropriate for participation in this study.
4.InBody body composition analysis will not be performed in patients with a pacemaker or implantable cardioverter-defibrillator.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 28 Day
Date of IRB - 2026 Year 05 Month 18 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070998
Disclaimer: Curated by HT Syndication.