Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer (NISS)

University Hospital Ostrava

Status: Completed

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Dietary supplement

Study type: Observational

Funder types: Other

Identifiers

NCT03930888

CHIR-04-NISS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Patients with nutritional support

Description:

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.

Treatment:

Dietary Supplement: Dietary supplement

Patients without nutritional support

Description:

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.

Treatment:

Dietary Supplement: Dietary supplement