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Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer (NISS)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer | Dietary Supplement: Dietary supplement |
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.
| Study Type : | Observational |
| Actual Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official 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 |
| Actual Study Start Date : | January 1, 2019 |
| Actual Primary Completion Date : | June 30, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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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Dietary Supplement: Dietary supplement
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.
|
Dietary Supplement: Dietary supplement
Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
|
- Changes in muscle strength [ Time Frame: 6 days ]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.
- Comparison of muscle mass [ Time Frame: 6 days ]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.
- Self sufficiency [ Time Frame: 6 days ]
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.
- Progression of the muscle strength [ Time Frame: 6 days ]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.
- Progression of the muscle mass [ Time Frame: 6 days ]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.
- Progression of the self sufficiency [ Time Frame: 6 days ]
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.
- Nutrition status [ Time Frame: 1 days ]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.
- Effect of tumor localization [ Time Frame: 6 days ]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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
| Czechia | |
| University Hospital Ostrava | |
| Ostrava, Moravian-Silesian Region,, Czechia, 70852 | |
| Principal Investigator: | Milan Tesař, MD | University Hospital Ostrava |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 9, 2019 | ||||
| First Posted Date | April 29, 2019 | ||||
| Last Update Posted Date | October 6, 2020 | ||||
| Actual Study Start Date | January 1, 2019 | ||||
| Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer | ||||
| Official 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 | ||||
| Brief Summary |
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. |
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| Detailed Description |
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients undergoing resection of colon or rectum due to colorectal cancer. | ||||
| Condition | Colorectal Cancer | ||||
| Intervention | Dietary Supplement: Dietary supplement
Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
120 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | June 30, 2020 | ||||
| Actual Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Czechia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03930888 | ||||
| Other Study ID Numbers | CHIR-04-NISS | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital Ostrava | ||||
| Study Sponsor | University Hospital Ostrava | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Hospital Ostrava | ||||
| Verification Date | October 2020 | ||||
