Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial

This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled.The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (Numerical Rating Scale (NRS)), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps.Ethics and disseminationThe study protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations.Trial registrationjRCTs 03220332. Registered on 21 January 2021
Source: Trials - Category: Research Source Type: clinical trials