Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer (NISS)
Nutritional Support and Its Influence on the Reduction of Muscle Strength, Muscle Mass and Self-sufficiency in Patients Undergoing Surgical Treatment of Colorectal Cancer
According to available data, 30-60% of patients are undernourished at hospital admission. The significance of the perioperative nutrition has already been studied in the 1930s. The outcomes of published studies demonstrated that patients with basic nutrient deficiencies have a higher frequency of postoperative complications and have a significantly longer recovery period.
The main aim of the this prospective clinical trial is to evaluate the loss of muscle mass and strength of the patient, the self-sufficiency and the possibility of returning to normal activities, in relation to pre-operatively served nutritional supplements in patients undergoing elective surgery for colorectal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Malnutrition is a pathological condition of the body caused by a deficiency of essential nutrients. The main feature is protein deficiency, which is caused by disruption of protein and energy balance and needs in the body. According to available data, 30-60% of patients are undernourished at hospital admission. The significance of the perioperative nutrition has already been studied in the 1930s. The outcomes of published studies demonstrated that patients that patients with basic nutrient deficiencies have a higher frequency of postoperative complications and have a significantly longer recovery period.
In 1992, a randomized clinical trial "Peri-operative nutritional support" showed that 85% of hospitalized seniors have malnutrition. The study demonstrated the need for nutritional training to prevent complications and clearly showed a relationship between malnutrition and reconvalescence length and mortality rate. In 2004, another large randomized trial ("Randomized clinical trial of the effects of preoperative and post operative oral nutritional supplements on clinical course and cost of care") confirmed the relationship between malnutrition and the incidence of all perioperative complications. Several other studies, which have been realized within the last decade, confirmed the positive effect of good nutritional condition on postoperative morbidity and mortality.
To the best of the investigator's knowledge, all clinical trials dealing with the issue of preoperative nutrition (published up to now) were primarily focused on the research of the relationship between malnutrition and the frequency of postoperative complications.
The main aim of the this prospective clinical trial is to evaluate the loss of muscle mass and strength of the patient, the self-sufficiency and the possibility of returning to normal activities, in relation to pre-operatively served nutritional supplements in patients undergoing elective surgery for colorectal cancer.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Moravian-Silesian Region,
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Ostrava, Moravian-Silesian Region,, Chequia, 70852
- University Hospital Ostrava
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- age ≥18 years
- resection of colon or rectum due to colorectal cancer
Exclusion Criteria:
- generalization of the disease
- intestinal co-morbidity
- duplicate malignancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Patients with nutritional support
Evaluation of changes in muscle strength, muscle mass and self-sufficiency (ADL-Activites of Daily Living) over a 5-day time period in patients nutritionally supported by nutritional supplements.
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Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
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Patients without nutritional support
Evaluation of changes in muscle strength, muscle mass and self-sufficiency (ADL-Activites of Daily Living) over a 5-day time period in patients without special nutritional supplements.
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Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in muscle strength
Periodo de tiempo: 6 days
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Muscle strength will be measured in kilograms and changes over a 5-6 day time period in patients nutritionally supported by nutritional supplements and patients without special nutritional supplements will be analysed.
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6 days
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Comparison of muscle mass
Periodo de tiempo: 6 days
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Muscle mass will be measured in % of whole body weight and changes over a 5-6 day time period in patients nutritionally supported by nutritional supplements and patients without special nutritional supplements will be analysed.
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6 days
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Self sufficiency
Periodo de tiempo: 6 days
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Self sufficiency will be analysed by Barthel Index for Activities of Daily Living, and changes over a 5-6 day time period in patients nutritionally supported by nutritional supplements and patients without special nutritional supplements will be analysed. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. The amount of time and physical assistance required to perform each item are used in determining the assigned value of each item. The total score is 0-100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. |
6 days
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Progression of the muscle strength
Periodo de tiempo: 6 days
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Muscle strength will be measured in kilograms.
The comparison of muscle strength and its progression within 5-6 days between patients with malnutrition and patients in a nutritionally optimal status at hospital admission will be analysed, in relation to patients nutritionally supported by nutritional supplements and patients without special nutritional supplements.
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6 days
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Progression of the muscle mass
Periodo de tiempo: 6 days
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Muscle mass will be measured in % of whole body weight.
The comparison of muscle mass and its progression within 5-6 days between patients with malnutrition and patients in a nutritionally optimal status at hospital admission will be analysed, in relation to patients nutritionally supported by nutritional supplements and patients without special nutritional supplements.
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6 days
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Progression of the self sufficiency
Periodo de tiempo: 6 days
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Self sufficiency will be analysed by Barthel Index for Activities of Daily Living. The comparison of self sufficiency and its progression within 5-6 days between patients with malnutrition and patients in a nutritionally optimal status at hospital admission will be analysed, in relation to patients nutritionally supported by nutritional supplements and patients without special nutritional supplements. The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. The amount of time and physical assistance required to perform each item are used in determining the assigned value of each item. The total score is 0-100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. |
6 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Nutrition status
Periodo de tiempo: 1 days
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Nutrition status will be measured by value of concentrations of albumin and prealbumin (transthyretin) in g/l at day of hospital admission.
The comparison of the nutrition status in patients with/without preoperative nutritional supplements will be analysed.
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1 days
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Effect of tumor localization
Periodo de tiempo: 6 days
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The evaluation whether tumor localization (colon caecum, ascendens, flexura hepatica, colon transversum, flexura lienalis, colon descendens, sigmoideum rectum, anus) affects the pre-operative nutrition status of the patient's (will be measured by value of concentrations of albumin and prealbumin (transthyretin) in g/l at day of hospital admission) and subsequently post-operative progression.
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6 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Milan Tesař, MD, University Hospital Ostrava
Publicaciones y enlaces útiles
Publicaciones Generales
- Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8.
- Manasek V, Bezdek K, Foltys A, Klos K, Smitka J, Smehlik D. The Impact of High Protein Nutritional Support on Clinical Outcomes and Treatment Costs of Patients with Colorectal Cancer. Klin Onkol. 2016 Fall;29(5):351-357.
- Bruns ERJ, Argillander TE, Van Den Heuvel B, Buskens CJ, Van Duijvendijk P, Winkels RM, Kalf A, Van Der Zaag ES, Wassenaar EB, Bemelman WA, Van Munster BC. Oral Nutrition as a Form of Pre-Operative Enhancement in Patients Undergoing Surgery for Colorectal Cancer: A Systematic Review. Surg Infect (Larchmt). 2018 Jan;19(1):1-10. doi: 10.1089/sur.2017.143. Epub 2017 Oct 19.
- Tanaka T, Sato T, Yamashita K, Hosoda K, Nakamura T, Watanabe M. Effect of Preoperative Nutritional Status on Surgical Site Infection in Colorectal Cancer Resection. Dig Surg. 2017;34(1):68-77. doi: 10.1159/000448123. Epub 2016 Jul 28.
- Yamano T, Yoshimura M, Kobayashi M, Beppu N, Hamanaka M, Babaya A, Tsukamoto K, Noda M, Matsubara N, Tomita N. Malnutrition in rectal cancer patients receiving preoperative chemoradiotherapy is common and associated with treatment tolerability and anastomotic leakage. Int J Colorectal Dis. 2016 Apr;31(4):877-84. doi: 10.1007/s00384-016-2507-8. Epub 2016 Feb 18.
- Tesar M, Kozusnikova V, Martinek L, Durdik S, Ihnat P. Preoperative nutritional support for patients undergoing elective colorectal cancer surgery - does it really work? Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 Mar 1. doi: 10.5507/bp.2022.009. Online ahead of print.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHIR-04-NISS
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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