Aro Raila, Ohtonen Pasi, Rautio Tero, Saarnio Juha, Mäkäräinen Elisa, Häivälä Reetta, Mäkinen Markus J, Tuomisto Anne, Schwab Ursula, Meriläinen Sanna
Department of Gastrointestinal Surgery, Medical Research Center Oulu, Oulu University Hospital, PL 10, 90029 OYS, Oulu, Finland.
Division of Operative Care, Medical Research Center Oulu, Oulu University Hospital, PL 10, 90029 OYS, Oulu, Finland.
BMC Nutr. 2022 Sep 2;8(1):89. doi: 10.1186/s40795-022-00591-y.
Colon cancer is one of the most common cancers in Finland and worldwide. Cancer-related malnutrition is a well-known risk factor for increased morbidity and mortality after surgery, and it is associated with complications and longer hospitalizations. There are no established recommendations on how to improve the nutritional status of colon cancer patients´ during the perioperative phase. Administration of simple oral nutritional supplements has been suggested to reduce complication rates, but evidence to support this practice is scarce.
The Peri-Nutri trial is a prospective, multicenter, randomized, controlled trial. Its primary endpoint is to evaluate whether perioperative oral nutritional support (ONS) decreases the number of complications during the 30-day follow-up after surgery. Secondary endpoints are to study the effect of ONS on quality of life after surgery, length of stay in institutional care, 90-day mortality rate, five-year disease-free survival and overall survival. The patients with a Nutritional risk screening 2002 (NRS-2002) questionnaire result between 2 and 5 (≥ 3 are classified at risk of malnutrition) will be randomized (1:1 ratio) into either the intervention or control group. The intervention group will receive preoperative ONS two weeks before the operation, and nutritional support will continue 10 days after the operation. The control group will not receive ONS. A total of 318 patients will be randomized into two groups and patients are followed five years.
Peri-Nutri study evaluate the impact of ONS to short-term and long-term postoperative morbidity and mortality rates of colon cancer patients undergoing curative surgery. If ONS will decrease patients´ morbidity and mortality, that has a huge impact on patients´ quality of life and also to financial cost.
ClinicalTrials.gov, NCT03863236 , Registered 25 February 2019.
结肠癌是芬兰和全球最常见的癌症之一。癌症相关营养不良是术后发病率和死亡率增加的一个众所周知的风险因素，它与并发症和更长的住院时间相关。目前尚无关于如何在围手术期改善结肠癌患者营养状况的既定建议。有人建议给予简单的口服营养补充剂以降低并发症发生率，但支持这种做法的证据很少。
围手术期营养试验是一项前瞻性、多中心、随机对照试验。其主要终点是评估围手术期口服营养支持（ONS）是否能减少术后30天随访期间的并发症数量。次要终点是研究ONS对术后生活质量、机构护理住院时间、90天死亡率、五年无病生存率和总生存率的影响。营养风险筛查2002（NRS-2002）问卷结果在2至5之间（≥3被归类为有营养不良风险）的患者将按1:1的比例随机分为干预组或对照组。干预组将在手术前两周接受术前ONS，术后营养支持将持续10天。对照组不接受ONS。共有318名患者将被随机分为两组，并对患者进行五年随访。
围手术期营养研究评估ONS对接受根治性手术的结肠癌患者术后短期和长期发病率及死亡率的影响。如果ONS能降低患者的发病率和死亡率，那将对患者的生活质量以及经济成本产生巨大影响。
ClinicalTrials.gov，NCT03863236，2019年2月25日注册。
