Bausys Augustinas, Luksta Martynas, Kuliavas Justas, Anglickiene Giedre, Maneikiene Vyte, Gedvilaite Lina, Celutkiene Jelena, Jamontaite Ieva, Cirtautas Alma, Lenickiene Svetlana, Vaitkeviciute Dalia, Gaveliene Edita, Klimaviciute Gertruda, Bausys Rimantas, Strupas Kestutis
Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University.
Department of Medical Oncology, National Cancer Institute.
Medicine (Baltimore). 2020 Jul 2;99(27):e20687. doi: 10.1097/MD.0000000000020687.
Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer.
PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board.
PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer.
ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).
手术是胃癌唯一可能的治愈性治疗方法,然而,其术后发病率和死亡率很高。最近一项随机对照试验提出了术前康复训练以降低接受大型腹部手术患者的术后发病率。目前,缺乏针对接受胃癌胃切除术患者进行术前康复训练的证据。我们研究的目的是证明居家术前康复训练可降低胃癌胃切除术后的发病率。
PREFOG是一项多中心、开放标签的随机对照试验,比较接受或未接受术前康复训练的胃癌患者胃切除术后90天的发病率。128名患者将被随机分为干预组或对照组。干预组将接受包括营养、心理和运动干预在内的三模式居家术前康复训练。研究的次要结局将包括身体和营养状况、焦虑和抑郁水平、生活质量、术后死亡率以及多学科肿瘤委员会确定的肿瘤治疗的完全完成情况。
PREFOG研究将表明三模式居家术前康复训练是否能有效降低胃癌胃切除术后的发病率。此外,这项研究将使我们能够确定术前康复训练是否能改善胃癌胃切除术后的身体素质和活动水平、营养状况和生活质量,以及降低焦虑和抑郁水平。
ClinicalTrials.gov NCT04223401(首次发布:2020年1月10日)。