Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation

Stefanus van Rooijen; Francesco Carli; Susanne Dalton; Gwendolyn Thomas; Rasmus Bojesen; Morgan Le Guen; Nicolas Barizien; Rashami Awasthi; Enrico Minnella; Sandra Beijer; Graciela Martínez-Palli; Rianne van Lieshout; Ismayil Gögenur; Carlo Feo; Christoffer Johansen; Celena Scheede-Bergdahl; Rudi Roumen; Goof Schep; Gerrit Slooter

doi:10.1186/s12885-018-5232-6

Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation

Stefanus van Rooijen, Francesco Carli, Susanne Dalton, Gwendolyn Thomas, Rasmus Bojesen, Morgan Le Guen, Nicolas Barizien, Rashami Awasthi, Enrico Minnella, Sandra Beijer, Graciela Martínez-Palli, Rianne van Lieshout, Ismayil Gögenur, Carlo Feo, Christoffer Johansen, Celena Scheede-Bergdahl, Rudi Roumen, Goof Schep, Gerrit Slooter^*

^*Corresponding author for this work

Department of Clinical Medicine

49 Citations (Scopus)

21 Downloads (Pure)

Abstract

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.

Original language	English
Article number	98
Journal	BMC Cancer
Volume	19
Number of pages	11
ISSN	1471-2407
DOIs	https://doi.org/10.1186/s12885-018-5232-6
Publication status	Published - 22 Jan 2019

Keywords

Adult
Aged
Aged, 80 and over
Colonic Neoplasms/rehabilitation
Colorectal Neoplasms/rehabilitation
Combined Modality Therapy/methods
Cost-Benefit Analysis
Digestive System Surgical Procedures/adverse effects
Humans
Middle Aged
Postoperative Complications/etiology
Postoperative Period
Preoperative Care/methods
Prospective Studies
Recovery of Function/physiology
Treatment Outcome
Young Adult

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., Barizien, N., Awasthi, R., Minnella, E., Beijer, S., Martínez-Palli, G., van Lieshout, R., Gögenur, I., Feo, C., Johansen, C., Scheede-Bergdahl, C., Roumen, R., Schep, G., & Slooter, G. (2019). Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer, 19, Article 98. https://doi.org/10.1186/s12885-018-5232-6

Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. / van Rooijen, Stefanus; Carli, Francesco; Dalton, Susanne et al.
In: BMC Cancer, Vol. 19, 98, 22.01.2019.

Research output: Contribution to journal › Journal article › Research › peer-review

van Rooijen, S, Carli, F, Dalton, S, Thomas, G, Bojesen, R, Le Guen, M, Barizien, N, Awasthi, R, Minnella, E, Beijer, S, Martínez-Palli, G, van Lieshout, R, Gögenur, I, Feo, C, Johansen, C, Scheede-Bergdahl, C, Roumen, R, Schep, G & Slooter, G 2019, 'Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation', BMC Cancer, vol. 19, 98. https://doi.org/10.1186/s12885-018-5232-6

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abstract = "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.",

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author = "{van Rooijen}, Stefanus and Francesco Carli and Susanne Dalton and Gwendolyn Thomas and Rasmus Bojesen and {Le Guen}, Morgan and Nicolas Barizien and Rashami Awasthi and Enrico Minnella and Sandra Beijer and Graciela Mart{\'i}nez-Palli and {van Lieshout}, Rianne and Ismayil G{\"o}genur and Carlo Feo and Christoffer Johansen and Celena Scheede-Bergdahl and Rudi Roumen and Goof Schep and Gerrit Slooter",

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journal = "BMC Cancer",

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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.

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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

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DO - 10.1186/s12885-018-5232-6

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SN - 1471-2407

VL - 19

JO - BMC Cancer

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