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The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST).
The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST). The study will be carried out in the General Surgery and Digestive Diseases Services of the following hospitals:
Primary objective: to demonstrate the non-inferiority in the therapeutic efficacy of a postoperative diet with an oligomeric-hyperprotéic-normocaloric supplement versus a supplement with imunonutrients, in patients under the multimodal rehabilitation regimen (fast-track) of colorectal surgery of colon cancer and who arrive at the Surgery in normal nutritional status or without any intervention on their nutritional status, according to the Malnutrition Screening Tool (MST) scale. The proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery will be considered the main parameter of effectiveness.
Secondary Objectives: to demonstrate the non-inferiority in therapeutic safety of a postoperative diet with oligomeric-hyperprotéic-normocaloric supplement versus a supplement with imunonutrients, in a multimodal rehabilitation regimen (ERAS) of colon cancer colorectal surgery, through:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surmimed®OPD Drink | Experimental | Normocaloric oligomeric-hyperprotein supplement |
|
| Atempero® or Impact® | Active Comparator | Inmunonutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition supplement | Dietary Supplement | Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Tolerance | The evaluation in each treatment group of the oral tolerance to the supplements, as a total adherence if the indicated daily volume (400 ml) is consumed, the partiality of half of the indicated volume (200 ml) and is not met in the minor . 200 ml / day. | 5 days |
| Clavien-Dindo Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilio Peña Ros, PhD | Contact | 686797476 | emilio.doctor@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Alejandro Benavides Buleje, PhD | Hospital General Universitario Reina Sofía | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Reina Sofía | Recruiting | Murcia | 30003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10378201 | Background | Ferguson M, Capra S, Bauer J, Banks M. Development of a valid and reliable malnutrition screening tool for adult acute hospital patients. Nutrition. 1999 Jun;15(6):458-64. doi: 10.1016/s0899-9007(99)00084-2. | |
| 28385477 | Background | Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. |
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Randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate non-inferiority in efficacy and therapeutic safety
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The masking procedure of the reference treatment and the study treatment will be carried out in the pharmacy service, since the packaging of the two treatments is different, brick and bottle. Pharmacy will keep the list of randomization, so at all times the pharmacy service will know which group each patient belongs to.
Both treatments will be re-packaged in 250 ml topaz plastic bottles (Code 225433) with the same label. The re-packaging will be carried out daily in aseptic conditions and by pharmacy personnel, it will be done per patient and in no time neither the patient nor the researcher will know the group to which the patient belongs.
In the program that the pharmacy service uses for the realization of the master formulas, the formula NUTRICOLON will be created with its corresponding procedure and label, always keeping the confidentiality of the product used.
Comparison of the percentage of patients in each treatment group of postoperative complications according to the Clavien-Dindo classification, up to 30 days from the date of surgery. |
| 30 days |
| Site Infection | Comparison of the percentage of patients in each treatment group of the surgical site infection according to the classification of the Centers for Disease Control and Prevention -CDC- , up to 30 days from the date of surgery | 30 days |
| Readmission | The comparison in each treatment group of the percentage of patients who have required hospital readmission attributed to the surgical act, up to 30 days from the date of surgery. | 30 days |
| Death | The comparison in each treatment group of the percentage of patients who have died attributed to the surgical act, up to 30 days from the date of surgery. | 30 days |
| Hospital Stay | The comparison in each treatment group of the average postoperative hospital stay. | 30 days |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 24799638 | Background | Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27. doi: 10.1086/676022. |
| 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. |
| 27926559 | Background | Thornblade LW, Varghese TK Jr, Shi X, Johnson EK, Bastawrous A, Billingham RP, Thirlby R, Fichera A, Flum DR. Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. Dis Colon Rectum. 2017 Jan;60(1):68-75. doi: 10.1097/DCR.0000000000000740. |
| 27571677 | Background | Wanden-Berghe C, Sanz-Valero J, Arroyo-Sebastian A, Cheikh-Moussa K, Moya-Forcen P. [Effects of a nutritional intervention in a fast-track program for a colorectal cancer surgery: systematic review]. Nutr Hosp. 2016 Jul 19;33(4):402. doi: 10.20960/nh.402. Spanish. |
| 17922951 | Background | Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. doi: 10.1017/S0007114507832909. |
| 18301092 | Background | Kreymann KG. Early nutrition support in critical care: a European perspective. Curr Opin Clin Nutr Metab Care. 2008 Mar;11(2):156-9. doi: 10.1097/MCO.0b013e3282f44c41. |
| 17413286 | Background | Skipworth RJ, Fearon KC. The scientific rationale for optimizing nutritional support in cancer. Eur J Gastroenterol Hepatol. 2007 May;19(5):371-7. doi: 10.1097/MEG.0b013e3280bdbf87. |
| 17356942 | Background | Finco C, Magnanini P, Sarzo G, Vecchiato M, Luongo B, Savastano S, Bortoliero M, Barison P, Merigliano S. Prospective randomized study on perioperative enteral immunonutrition in laparoscopic colorectal surgery. Surg Endosc. 2007 Jul;21(7):1175-9. doi: 10.1007/s00464-007-9238-4. Epub 2007 Mar 14. |
| 16768026 | Background | Garcia-Luna PP, Parejo Campos J, Pereira Cunill JL. [Causes and impact of hyponutrition and cachexia in the oncologic patient]. Nutr Hosp. 2006 May;21 Suppl 3:10-6. Spanish. |
| 22470013 | Background | Garcia de Lorenzo A, Alvarez Hernandez J, Planas M, Burgos R, Araujo K; multidisciplinary consensus work-team on the approach to hospital malnutrition in Spain. Multidisciplinary consensus on the approach to hospital malnutrition in Spain. Nutr Hosp. 2011 Jul-Aug;26(4):701-10. doi: 10.1590/S0212-16112011000400006. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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