Does Prehabilitation Improve Outcome in Coloncancer Surgery?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabilitation and Immunonutrition, Standard Care Arm.
- Who it may be relevant to
- Registry conditions: Surgery--Complications. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study
Overview
The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.
Detailed description
All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are \>=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.
The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.
Interventions
- Other Prehabilitation and Immunonutrition
See study synopsis - Other Standard Care Arm
Standard care as per the daily routines of the Hospital at which the study takes place
Primary outcome measures
- Complications [Time frame: Assessed when patient is discharged from hospital]
- Complications [Time frame: Assessed at postoperative day 5.]
Secondary outcome measures (3)
- Quality of life with SF-36 [Time frame: At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.]
- Disease-free survival [Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.]
- Overall survival [Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.]
Eligibility criteria
Inclusion criteria
- 60 years of older
- Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)
- Ventilatory Anaerobic Threshold <11mg/ml/kg
- Planned open or laparoscopic colectomy due to colon cancer
Exclusion criteria
- Lower extremity amputee
- Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease
- Distal metastases (Locoregional lymph nodes are OK)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04199208 · PRIO01