Status:
RECRUITING
A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri
Lead Sponsor:
University of Oulu
Conditions:
Colon Cancer
Sarcopenia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) u...
Detailed Description
The hypothesis in this study are: 1. Perioperative ONS decreases surgery related morbidity 2. Perioperative ONS increases the quality of life after surgery 3. Perioperative ONS decreases the length o...
Eligibility Criteria
Inclusion
- 18 years or older
- Primary colon adenocarcinoma
- Curative operation is possible
- Patient has a life expectancy of at least 12 months
- Patient signs the informed consent and agrees to attend all study visits
Exclusion
- Recurrent colon adenocarcinoma
- Metastatic disease
- Cancer that will require multiorgan resection
- Pregnant or suspected pregnancy
- Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 5).
- Patients with concurrent or previous malignant tumors within 5 years before the study enrollment
- Patient undergoing emergency procedures
- Dialysis
- Liver dysfunction, child pugh B or worse
- NRS score \<2 or \>5
- BMI under 18.5
- Weight loss 15% or more past 6 months
- Serum albumin less than 30 without liver or renal dysfunction
- Chronic malnutrition: short bowel syndrome, previous gastrectomy, pancreatic dysfunction
- Language barrier or other reasons why informed consent is not possible
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT03863236
Start Date
April 1 2019
End Date
April 1 2026
Last Update
May 18 2022
Active Locations (1)
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1
Oulu University Hospital
Oulu, Finland