Aro, R., Ohtonen, P., Rautio, T. et al. Perioperative oral nutritional support for patients diagnosed with primary colon adenocarcinoma undergoing radical surgical procedures -Peri-Nutri Trial: study protocol for a randomized controlled trial. BMC Nutr 8, 89 (2022). https://doi.org/10.1186/s40795-022-00591-y
Perioperative oral nutritional support for patients diagnosed with primary colon adenocarcinoma undergoing radical surgical procedures -Peri-Nutri Trial : study protocol for a randomized controlled trial
|Author:||Aro, Raila1; Ohtonen, Pasi2; Rautio, Tero1;|
1Department of Gastrointestinal Surgery, Medical Research Center Oulu, Oulu University Hospital, PL 10, 90029 OYS, Oulu, Finland
2Division of Operative Care, Medical Research Center Oulu, Oulu University Hospital, PL 10, 90029 OYS, Oulu, Finland
3Department of Pathology, Cancer and Translational Medicine Research Unit, University of Oulu, Oulu University Hospital and Medical Research Center Oulu, Oulu, Finland
4Department of Pathology, University of Oulu, Oulu University Hospital and Medical Research Center Oulu, Oulu, Finland
5School of Medicine, Institute of Public Health and Clinical Nutrition, Finland and Department of Medicine, Endocrinology and Clinical Nutrition, University of Eastern, Kuopio University Hospital, Kuopio, Finland
|Online Access:||PDF Full Text (PDF, 1.1 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2023030930759
|Publish Date:|| 2023-03-09
Background: 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.
Methods: 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.
Discussion: 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.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3141 Health care science
3126 Surgery, anesthesiology, intensive care, radiology
This work was supported by the Emil Aaltonen Foundation, Thelma Mäkikyrö Foundation, Vieno and Alli Suorsa Healthcare Foundation and The Finnish Medical Society Duodecim Oulu. Not applicable. The funding body has not been in any role in the design of the study and will not participate in the collection, analysis, and interpretation of data or in writing the manuscript.
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