NCT03930888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

April 9, 2019

Last Update Submit

October 5, 2020

Conditions

Colorectal Cancer

Keywords

nutritional supportcolorectal cancermuscle strengthmuscle massself-sufficiency

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Nutrition status

    1 days

  • Effect of tumor localization

    6 days

Study Arms (2)

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 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

Interventions

Dietary supplementDIETARY_SUPPLEMENT

Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.

Patients with nutritional supportPatients without nutritional support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • age ≥18 years
  • resection of colon or rectum due to colorectal cancer

You may not qualify if:

  • generalization of the disease
  • intestinal co-morbidity
  • duplicate malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region,, 70852, Czechia

Location

Related Publications (6)

  • 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.

    PMID: 27739314BACKGROUND

  • 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.

    PMID: 29750973BACKGROUND

  • 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.

    PMID: 29049000BACKGROUND

  • 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.

    PMID: 27463391BACKGROUND

  • 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.

    PMID: 26888783BACKGROUND

  • 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. 2023 Jun;167(2):145-151. doi: 10.5507/bp.2022.009. Epub 2022 Mar 1.

    PMID: 35258042DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Milan Tesař, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 29, 2019

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

The investigators do not plan to make individual participant data available to other researchers.

Locations

CZ(1)