Colorectal Cancer Clinical Trial
— NISSOfficial title:
Nutritional Support and Its Influence on the Reduction of Muscle Strength, Muscle Mass and Self-sufficiency in Patients Undergoing Surgical Treatment of Colorectal Cancer
NCT number | NCT03930888 |
Other study ID # | CHIR-04-NISS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | June 30, 2020 |
Verified date | October 2020 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region, |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
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. Review. — View Citation
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. Review. — View Citation
Manásek 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. Fall 2016;29(5):351-357. — View Citation
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. Epub 2016 Jul 28. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in muscle strength | 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. | 6 days | |
Primary | Comparison of muscle mass | 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. | 6 days | |
Primary | Self sufficiency | 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 | |
Primary | Progression of the muscle strength | 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. | 6 days | |
Primary | Progression of the muscle mass | 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. | 6 days | |
Primary | Progression of the self sufficiency | 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 | |
Secondary | Nutrition status | 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. | 1 days | |
Secondary | Effect of tumor localization | 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. | 6 days |
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