Prehabilitation for bowel cancer patients undergoing surgery to improve fitness and reduce complications

Recruiting

Conditions: Colorectal carcinoma

Registration Number: NL-OMON21887

Lead Sponsor: Máxima MC

Brief Summary: 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.<br> 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 715

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>

Secondary Outcome Measures

Name	Time	Method
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.