No registrations found.
ID
Source
Brief title
Health condition
Colorectal carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
Secondary outcomes will include indirect 1 repetition measures (1-RM) and cardiopulmonary exercise testing (CPET), Health-related quality of life (HRQL), Sit-to-Stand test, Fried Frailty Score, hand grip strength, body composition, stair climb test, Physical activity level measured through an activity questionnaire, depression and anxiety assessed by GAD-7 and PHQ-9, nutritional status, compliance, length of hospital stay, and costs.
Background summary
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.
Study objective
Multimodal prehabilitation decreases postoperative complications and improves functional capacity pre- and postoperatively for patients undergoing colorectal surgery for cancer.
Study design
Baseline (diagnosis), Preoperative (4 weeks after diagnosis), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Intervention
1. Patient triage medical conditions
2. Exercise program
3. Nutritional supplements
4. Smoke cessation
5. Psychological coping
Inclusion criteria
Adult patients undergoing elective colorectal surgery for cancer.
Exclusion criteria
• 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5784 |
| NTR-old | NTR5947 |
| CCMO | NL58281.015.16 |
| OMON | NL-OMON50479 |
Summary results
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