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A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.
Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutrition and ERAS | Active Comparator | Immunonutrition supplements will be provided to patients in the form of oral supplements given twice daily for 3 days pre-surgery and 3 days post-surgery. |
|
| ERAS without immunonutrition | No Intervention | Typical ERAS protocol will be followed for patients in that group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative infections | We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells | Postoperatively (30 days) |
| Duration of hospitalization | From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months. | Until discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative mobilization | From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months. | Until first day of mobilization |
| Postoperative morbidity (other than infectious) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos Thomakos, MD | Contact | +302132162291 | thomakir@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Thomakos, Pf | National Kapodistrian University of Athens,1st obs and gyn department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First department of Obstetrics and Gynecology | Recruiting | Athens | 11523 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29238571 | Background | Gupta R, Senagore A. Immunonutrition within enhanced recovery after surgery (ERAS): an unresolved matter. Perioper Med (Lond). 2017 Dec 11;6:24. doi: 10.1186/s13741-017-0080-5. eCollection 2017. | |
| 27227930 | Background | Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704. |
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Individual patient data will become available upon reasonable request
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Major events such as pulmonary embolism,accuse myocardial infarction,etc
| 30 days |
| Recurrence rates | Recurrent disease will be monitored through 3 year of follow up | 3 years follow-up |
| Overall survival | Overall survival of the patients will be measured through 3 year of follow up | 3 years follow-up |
| 28468890 | Background | Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3. |
| 32684485 | Background | Fiorindi C, Cuffaro F, Piemonte G, Cricchio M, Addasi R, Dragoni G, Scaringi S, Nannoni A, Ficari F, Giudici F. Effect of long-lasting nutritional prehabilitation on postoperative outcome in elective surgery for IBD. Clin Nutr. 2021 Mar;40(3):928-935. doi: 10.1016/j.clnu.2020.06.020. Epub 2020 Jul 1. |
| 30877144 | Background | Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15. |
| 37086524 | Background | Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21. |