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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer

Clinicaltrials.gov identifier NCT03930888

Recruitment Status Completed

First Posted April 29, 2019

Last update posted October 6, 2020

Study Description

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.

  • Condition or Disease:Colorectal Cancer
  • Intervention/Treatment: Dietary Supplement: Dietary supplement
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: June 2020
Groups and Cohorts
Groups/Cohorts 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.
Dietary Supplement: Dietary supplement
Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
: 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Patients undergoing resection of colon or rectum due to colorectal cancer.
Criteria

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

Contacts and Locations
Contacts
Locations

Czechia, Moravian-Silesian Region,
University Hospital Ostrava
Ostrava

Sponsors and Collaborators

University Hospital Ostrava

Investigators

Principal Investigator: Milan Tesař, MD University Hospital Ostrava

More Information