Multimodal prehabilitation decreases postoperative complications and improves functional capacity pre- and postoperatively for patients undergoing colorectal surgery for cancer.
ID
Bron
Verkorte titel
Aandoening
Colorectal carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The first primary outcome is postoperative complications, as scored using the Comprehensive Complication Index score as a combined outcome measure of morbidity and mortality. The second primary/confirmatory outcome is the patients’ functional capacity, as measured by the six-minute walk test (6MWT).
Achtergrond van het onderzoek
Background
Colorectal cancer (CRC) is the second most prevalent type of cancer in the World. The only way to cure is surgical removal of the tumor. However, postoperative complications occur in up to 50% of patients and are associated with a higher mortality- and return of cancer rate and increased hospital costs. The number and severity of complications is closely related to preoperative functional capacity, nutritional state and smoking behavior. Traditional approaches have targeted the postoperative period for rehabilitation and lifestyle changes. However, recent evidence shows that the preoperative period might be the optimal time frame for intervention. This study will determine the exact effect of prehabilitation on patients’ functional capacity and postoperative complications.
Methods/design
This international multicenter, prospective, randomized controlled trial will include 714 patients undergoing colorectal surgery for cancer. Patients will be allocated to an intervention group, receiving four weeks of prehabilitation or the control group receiving no prehabilitation. Both groups perioperative care following ERAS guidelines. The primary endpoints are functional capacity and postoperative status determined by the Comprehensive Complication Index (CCI). Secondary outcomes include health related quality of life (HRQoL), Patient Reported Outcome Measurements (PROMs), length of hospital stay and a cost-effectiveness analysis.
Discussion
This is the first international multicenter study focusing on multimodal prehabilitation for patients undergoing colorectal surgery for cancer. Prehabilitation is expected to increase functional capacity and to lower postoperative complications. Consequently, this may result in increased survival and improved HRQoL.
Doel van het onderzoek
Multimodal prehabilitation decreases postoperative complications and improves functional capacity pre- and postoperatively for patients undergoing colorectal surgery for cancer.
Onderzoeksopzet
Baseline (diagnosis), Preoperative (4 weeks after diagnosis), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Onderzoeksproduct en/of interventie
1. Patient triage medical conditions
2. Exercise program
3. Nutritional supplements
4. Smoke cessation
5. Psychological coping
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult patients undergoing elective colorectal surgery for cancer.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• metastatic disease known preoperatively,
• paralytic or immobilized patients (not capable to perform exercise or 6MWT),
• premorbid conditions or orthopedic impairments that contraindicate exercise (to be assessed by sport physician involved in and during cardiopulmonary exercise testing),
• cognitive disabilities,
• chronic renal failure (dialysis or creatinine > 250 µmol)m
• ASA score 4 or higher,
• illiteracy (disability to read and understand Dutch),
• planned abdominoperineal resection (inability to perform postoperative tests),
• second primary tumour other than colorectal carcinoma simultaneously diagnosed,
• not able to delay surgery for four weeks due to for example clinical signs of obstruction or short-course neoadjuvant radiotherapy, directly followed by surgery.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5784 |
| NTR-old | NTR5947 |
| CCMO | NL58281.015.16 |
| OMON | NL-OMON50479 |
Samenvatting resultaten
Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. BJS 2010; 97: 1187-1197.<br>
JJ Dronkers, H Lamberts, IMMD Reutelingsperger,
RH Naber, CM Dronkers-Landman, A Veldman and
NLU van Meeteren; Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: a randomized controlled pilot study. Clinical Rehabilitation 2010; 24: 614–622.<br>
GILLIS, C., LI, C., LEE, L., AWASTHI, R., AUGUSTIN, B., GAMSA, A., LIBERMAN, A.S., STEIN, B., CHARLEBOIS, P., FELDMAN, L.S. and CARLI, F., 2014. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology, 121(5), pp. 937-947