Background: 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.
Objectives: 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.
Material And Methods: 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.
Results: 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.
Conclusion: 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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