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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Dietary supplement

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region,
    • Ostrava, Moravian-Silesian Region,, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing resection of colon or rectum due to colorectal cancer.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Milan Tesař, MD, University Hospital Ostrava

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: colorectal cancer; muscle strength; muscle mass; self-sufficiency; nutritional support
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CHIR-04-NISS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No