Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061562) titled 'A prospective observational study of changes in quality of life and work productivity in individuals undergoing Metabolic and Bariatric Surgery' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Kobe University Graduate School of Medicine

Condition: Condition - Obesity disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to evaluate the change in the IWQOL-Lite-CT physical function composite score from baseline to 72 weeks after metabolic and bariatric surgery in patients with obesity disease who are scheduled to undergo metabolic and bariatric surgery under routine insured clinical care at Kobe University Hospital or Chibune Hospital.Secondary objectives are to evaluate longitudinal changes at 26, 52, 72, and 96 weeks after surgery in IWQOL-Lite-CT component scores and total score, SF-12 v2, WPAI, GPAQ, QDIS-7 obesity score, body weight, body mass index, waist circumference, body composition, obesity-related health conditions, laboratory data, medication use, postoperative complications, and CT-derived image indicators obtained in routine clinical practice. Exploratory objectives include the evaluation of the reliability, validity, and responsiveness of the QDIS-7 obesity version, clinical factors associated with changes in patient-reported outcomes, and associations between body composition or image-derived indicators and changes in patient-reported outcomes. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Age 18 years or older. Scheduled to undergo metabolic and bariatric surgery under routine insured clinical care at Kobe University Hospital or Chibune Hospital. Provided written informed consent to participate in this study. Key exclusion criteria - Individuals who are unable to sufficiently understand the Japanese questionnaires and respond based on their own will. Individuals currently undergoing treatment for malignancy, including hormone therapy. Individuals undergoing dialysis. Individuals who are pregnant or planning pregnancy. Individuals judged by the principal investigator or site investigator to be inappropriate for participation in this study. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2029 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070439

Disclaimer: Curated by HT Syndication.