Patients undergoing elective curatively intended surgery for colorectal cancer (colon and rectum) including resection of hepatic metastasis via atypical or anatomical minor liver resection in the same operation C18 C19 C20
Conditions
Interventions
Group 1: Intervention (minimum 3 weeks, maximum 24 weeks during neoadjuvant treatment): Structured individualised multimodal prehabilitation program containing the following components:
- Physical exe
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients (18 years or older) will be included in the trial if they meet all the following criteria: i) undergoing elective curatively intended surgery for colorectal cancer (colon and rectum) including resection of hepatic metastasis via atypical or anatomical minor liver re-section in the same operation ii) undergoing upfront surgical resection or resection following neoadjuvant chemo(radio-)therapy iii) in physical and cognitive condition to adequately conduct all components of the prehabilitation intervention iv) able to understand character and individual consequences of the clinical trial and to give written informed consent. In addition, at least one of the following validated criteria to be classified as “high-risk” must be fulfilled: i) Clinical frailty Scale (CFS) = 3, ii) Nutritional Risk Screening (NRS) 2002 = 3 iii) Age = 65 years iv) American Society of Anaesthesiologists (ASA) score = 3.
Exclusion criteria
Exclusion criteria: Patients with i) distant metastases (except for liver metastases with possible curatively intended resection via atypical or anatomical minor liver resection) ii) not colorectal-carcinoma as indication for colorectal surgery, iii) physical or psychological impairment (e. g. paralysis, mobility problems, delirium, major psychiatric disorders, etc.) that prevents participation in the prehabilitation program iv) ASA score >3 v) inability to postpone surgical resection for 3 weeks e. g. due to clinical indications such as signs of bowel obstruction vi) participation in another interventional trial with possible interference with the intervention or outcome of this trial vii) expected lack of compliance or language problems will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Recovery as defined by the QoR-15 questionnaire on postoperative day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical outcomes - Surgery-related complications until post-operative day (POD) 30 - Length of hospital stay from index operation until discharge - Re-admission rate until POD 60 - Mortality until POD 60 2. Functional outcomes at post intervention visit, POD 30 & 60 - Physical capacity (6-minute walk distance, hand grip strength, 30s-Sit-to-Stand) - Nutritional status (NRS 2002), Patient-Generated Subjective Global Assessment (PG-SGA), Prognostic Nutritional Index (PNI) 3. Patient reported outcome measures (PROMs) - QoR at POD 30 & 60 - EORTC QLQ-C30 at baseline, post intervention visit, POD 30 & 60 - Psychosocial status (Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), NCCN distress thermometer) at post intervention visit, POD 30 & 60 4. Compliance to prehab program assessed via patient diary during intervention Assessment of safety: Major complications during the prehabilitation intervention, postoperative complications defined as Clavien Dindo = grade 3 until POD 60 | — |
Countries
Germany
Contacts
Public ContactRosa Klotz
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed