TY - JOUR
T1 - Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications
T2 - the first international randomized controlled trial for multimodal prehabilitation
AU - van Rooijen, Stefanus
AU - Carli, Francesco
AU - Dalton, Susanne
AU - Thomas, Gwendolyn
AU - Bojesen, Rasmus
AU - Le Guen, Morgan
AU - Barizien, Nicolas
AU - Awasthi, Rashami
AU - Minnella, Enrico
AU - Beijer, Sandra
AU - Martínez-Palli, Graciela
AU - van Lieshout, Rianne
AU - Gögenur, Ismayil
AU - Feo, Carlo
AU - Johansen, Christoffer
AU - Scheede-Bergdahl, Celena
AU - Roumen, Rudi
AU - Schep, Goof
AU - Slooter, Gerrit
PY - 2019/1/22
Y1 - 2019/1/22
N2 - BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the only curative option. However, postoperative complications occur in up to 50% of patients and are associated with higher morbidity and mortality rates, lower health related quality of life (HRQoL) and increased expenditure in health care. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological 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 moment for intervention. This study will determine the impact of multimodal 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 the intervention group, which will receive 4 weeks of prehabilitation (group 1, prehab), or the control group, which will receive no prehabilitation (group 2, no prehab). Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with the Comprehensive Complication Index (CCI). Secondary outcomes will include HRQoL, length of hospital stay (LOS) and a cost-effectiveness analysis.DISCUSSION: Multimodal prehabilitation is expected to enhance patients' functional capacity and to reduce postoperative complications. It may therefore result in increased survival and improved HRQoL. This is the first international multicenter study investigating multimodal prehabilitation for patients undergoing colorectal surgery for cancer.TRIAL REGISTRATION: Trial Registry: NTR5947 - date of registration: 1 August 2016.
AB - BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the only curative option. However, postoperative complications occur in up to 50% of patients and are associated with higher morbidity and mortality rates, lower health related quality of life (HRQoL) and increased expenditure in health care. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological 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 moment for intervention. This study will determine the impact of multimodal 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 the intervention group, which will receive 4 weeks of prehabilitation (group 1, prehab), or the control group, which will receive no prehabilitation (group 2, no prehab). Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with the Comprehensive Complication Index (CCI). Secondary outcomes will include HRQoL, length of hospital stay (LOS) and a cost-effectiveness analysis.DISCUSSION: Multimodal prehabilitation is expected to enhance patients' functional capacity and to reduce postoperative complications. It may therefore result in increased survival and improved HRQoL. This is the first international multicenter study investigating multimodal prehabilitation for patients undergoing colorectal surgery for cancer.TRIAL REGISTRATION: Trial Registry: NTR5947 - date of registration: 1 August 2016.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Colonic Neoplasms/rehabilitation
KW - Colorectal Neoplasms/rehabilitation
KW - Combined Modality Therapy/methods
KW - Cost-Benefit Analysis
KW - Digestive System Surgical Procedures/adverse effects
KW - Humans
KW - Middle Aged
KW - Postoperative Complications/etiology
KW - Postoperative Period
KW - Preoperative Care/methods
KW - Prospective Studies
KW - Recovery of Function/physiology
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1186/s12885-018-5232-6
DO - 10.1186/s12885-018-5232-6
M3 - Journal article
C2 - 30670009
SN - 1471-2407
VL - 19
JO - BMC Cancer
JF - BMC Cancer
M1 - 98
ER -
