Pancreaticoduodenectomy (PD), an abdominal surgery, is known for its complexity, cost and inherent risks. Recently, there has been increasing interest in enhanced recovery after surgery (ERAS) as a therapeutic approach. However, the mechanisms underlying postoperative functional recovery remain uncertain, and there are limited data on the efficacy of ERAS in postoperative physiotherapy following complex PD. This study aims to examine the feasibility and effectiveness of conducting a large powered randomized controlled trial (RCT) to evaluate a 2-week postoperative rehabilitation program based on the ERAS concept for patients undergoing pancreaticoduodenectomy. This study is a RCT with a single treatment group. From June 2022 to June 2024, 28 PD patients will participate in the trial. Patients will be randomly assigned to either a control group receiving standard clinical care or an intervention group undergoing a 2-week postoperative rehabilitation program. Cardiopulmonary function will be assessed using the 6-minute walk test (6MWT), and gastrointestinal (GI) recovery will be evaluated using the Intake, Feeling nausea, Emesis, physical Exam, and Duration of symptoms (I-FEED) scoring system. Secondary outcomes, including changes in recovery quality post-surgery, will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and the Quality of Recovery Questionnaire (QOR-40). Additional recorded items will include time to first flatus and feces, daily volume of stomach fluid, time to gastric tube removal, length of hospital stay (LOS), and postoperative complications. The study will utilize the I-FEED score, a novel tool for assessing GI function, to monitor the impact of a 2-week postoperative rehabilitation exercise program on patients. The primary outcome will focus on improvements in cardiopulmonary capacity following postoperative rehabilitation activities.
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