Short-term multi-modal prehabilitation intervention in patients undergoing limited operation for gastrointestinal cancer: study protocol for a randomized controlled clinical trial

Abstract

Abstract Background Surgical trauma produces systemic stress response that may have a detrimental effect on clinical outcome. The aim of the present study is to evaluate the possible effects of short-term multi-modal prehabilitation intervention on post-operative systemic stress response in patients undergoing limited operation for gastrointestinal cancer. Methods/design: In this clinical trial, 80 patients with nonmetastatic gastrointestinal cancer will be randomly assigned to two groups (Group 1: usual care according to standard perioperative protocol of Department of General Surgery, Shanghai General Hospital; Group 2: five-day multi-modal prehabilitation program prior to surgery which is supervised by a multidisciplinary team in hospital ). The primary outcome is post-operative systemic stress response. The secondary outcomes are pulmonary function levels, nutritional status, depression and anxiety, postoperative early mobilization and the length of postoperative hospitalization. Discussion The study results may help to evaluate the efficacy and safety of short-term multi-modal prehabilitation intervention on post-operative systemic stress response in patients undergoing limited operation for gastrointestinal cancer. This trial may provide a novel method of preventing or attenuating the systemic stress response and further promoting earlier postoperative mobilization and less postoperative hospitalization. Trial registration: Chinese Clinical Trial Registry, ChiCTR2200055764. Registered on 19 January 2022. Prospective registration.