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

Y1 - 2019

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

VL - 19

JO - B M C Cancer

JF - B M C Cancer

SN - 1471-2407

M1 - 98

ER -