Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062999) titled 'Assessment of Gastroesophageal Reflux Disease (GERD) Before and After Sleeve Gastrectomy in Patients with Obesity' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Condition:
Condition - patients with obesity undergoing sleeve gastrectomy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate the severity of gastroesophageal reflux disease (GERD) before and after sleeve gastrectomy in patients with obesity and to assess the therapeutic efficacy of vonoprazan.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - If patients are diagnosed with GERD, treatment with vonoprazan 20 mg once daily will be initiated and continued for 4 weeks.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 20 years or older with obesity who meet the surgical criteria for sleeve gastrectomy.
Key exclusion criteria - 1. Patients considered unsuitable for participation by the principal investigator or a sub-investigator.
2. Patients from whom informed consent cannot be obtained from the patient or their legally authorized representative (or family member, if applicable).
Target Size - 100
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 04 Month 01 Day
Date of IRB - 2022 Year 03 Month 31 Day
Anticipated trial start date - 2022 Year 04 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071445
Disclaimer: Curated by HT Syndication.
