Prehabilitation for bowel cancer patients undergoing surgery to improve fitness and reduce complications|
|- candidate number||24714|
|- NTR Number||NTR5947|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-aug-2016|
|- Secondary IDs||NL58281.015.16 |
|- Public Title||Prehabilitation for bowel cancer patients undergoing surgery to improve fitness and reduce complications|
|- Scientific Title||Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and lower postoperative complications|
|- hypothesis||Multimodal prehabilitation decreases postoperative complications and improves functional capacity pre and postoperatively for patients undergoing colorectal surgery for cancer.|
|- Healt Condition(s) or Problem(s) studied||Bowel cancer, Rehabilitation, Complications|
|- Inclusion criteria||Adult patients undergoing elective colorectal surgery for cancer.|
|- Exclusion criteria||• metastatic disease known preoperatively, |
• paralytic or immobilized patients,
• premorbid conditions or orthopedic impairments that contraindicated exercise,
• cognitive disabilities,
• renal failure stage 3 or higher,
• ASA score 4 or higher,
• use of neoadjuvant therapy.
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2016|
|- planned closingdate||1-okt-2019|
|- Target number of participants||700|
|- Interventions||1. Patient triage medical conditions|
2. Exercise program
3. Nutritional supplements
4. Smoke cessation
5. Psychological coping
|- 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 the Community Health Activities Model Program for Seniors (CHAMPS), depression and anxiety assessed by GAD-7 and PHQ-9, nutritional status, compliance, length of hospital stay, and costs.|
|- Timepoints||Baseline (diagnosis), Preoperative (4 weeks after diagnosis), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative|
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES||dr. Gerrit Slooter|
|- CONTACT for SCIENTIFIC QUERIES||dr. Gerrit Slooter|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center|
|- Publications||Kim DJ, Mayo NE, Carli F, Montgomery DL and Zavorsky GS; Responsive Measures to Prehabilitation in Patients undergoing bowel resection surgery. Toboku J. Exp. Med. 2009, 217, 109-115.|
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.
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.
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
|- Brief 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.
This international multicenter, prospective, randomized controlled trial will include 644 patients undergoing colorectal surgery for cancer. Patients will be allocated an intervention group, receiving 4 weeks prehabilitation (group 1, prehab) or the control group receiving no prehabilitation (group 2, no- prehab). Both groups obtain 8 weeks rehabilitation 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.
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.
Netherlands, Canada, Denmark, France
|- Main changes (audit trail)|
|- RECORD||1-aug-2016 - 23-aug-2016|
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