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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 2019; 19(1):98BC

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.

Links

  • PMC Free PDF
    • Publisher Full Text
    ncbi.nlm.nih.gov
    bmccancer.biomedcentral.com

    Authors+Show Affiliations

    van Rooijen S
    Department of Surgical Oncology, Máxima Medical Center, Veldhoven, the Netherlands.
    Carli F
    Department of Anesthesiology, the Montréal General Hospital, McGill University, Montréal, Canada.
    Dalton S
    Danish Cancer Society Research Center, Copenhagen, Denmark.
    Thomas G
    Department of Surgical Oncology, Máxima Medical Center, Veldhoven, the Netherlands.
    Bojesen R
    Department of Surgery, Center for Surgical Science, Zealand University Hospital, Køge, Denmark.
    Le Guen M
    Department of Anesthesiology, Foch Hôpital, Paris, France.
    Barizien N
    Department of Sports Medicine, Foch Hôpital, Paris, France.
    Awasthi R
    Department of Anesthesiology, the Montréal General Hospital, McGill University, Montréal, Canada.
    Minnella E
    Department of Anesthesiology, the Montréal General Hospital, McGill University, Montréal, Canada.
    Beijer S
    Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands.
    Martínez-Palli G
    Department of Anesthesiology, Hospital Clinic de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.
    van Lieshout R
    Department of Nutrition, Máxima Medical Center, Veldhoven, the Netherlands.
    Gögenur I
    Department of Surgery, Center for Surgical Science, Zealand University Hospital, Køge, Denmark.
    Feo C
    Department of Surgery, S. Anna University Hospital, Ferrara, Italy.
    Johansen C
    Danish Cancer Society Research Center, Copenhagen, Denmark. Department of Oncology, Finsen Center, Rigshospitalet, Copenhagen, Denmark.
    Scheede-Bergdahl C
    Department of Surgery, Center for Surgical Science, Zealand University Hospital, Køge, Denmark. Department of Kinesiology and Physical Education, McGill University, Montréal, Canada.
    Roumen R
    Department of Surgical Oncology, Máxima Medical Center, Veldhoven, the Netherlands.
    Schep G
    Department of Sports Medicine, Máxima Medical Center, Veldhoven, the Netherlands.
    Slooter G
    Department of Surgical Oncology, Máxima Medical Center, Veldhoven, the Netherlands. g.slooter@mmc.nl. Department of Surgery, Máxima Medical Center, P.O. Box 7777, Veldhoven, the Netherlands. g.slooter@mmc.nl.

    MeSH

    AdultAgedAged, 80 and overColonic NeoplasmsColorectal NeoplasmsCombined Modality TherapyCost-Benefit AnalysisDigestive System Surgical ProceduresHumansMiddle AgedPostoperative ComplicationsPostoperative PeriodPreoperative CareProspective StudiesRecovery of FunctionTreatment OutcomeYoung Adult

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    30670009

    Citation

    van Rooijen, Stefanus, et al. "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, no. 1, 2019, p. 98.
    van Rooijen S, Carli F, Dalton S, et al. 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. 2019;19(1):98.
    van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., ... 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(1), p. 98. doi:10.1186/s12885-018-5232-6.
    van Rooijen S, et al. 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. 2019 Jan 22;19(1):98. PubMed PMID: 30670009.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: 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, Y1 - 2019/01/22/ PY - 2017/02/02/received PY - 2018/12/19/accepted PY - 2019/1/24/entrez PY - 2019/1/24/pubmed PY - 2019/1/24/medline KW - Colorectal cancer KW - Colorectal surgery KW - Comprehensive complication index KW - Enhanced recovery after surgery KW - Functional capacity KW - Postoperative complications KW - Prehabilitation SP - 98 EP - 98 JF - BMC cancer JO - BMC Cancer VL - 19 IS - 1 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. SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/30670009/Multimodal_prehabilitation_in_colorectal_cancer_patients_to_improve_functional_capacity_and_reduce_postoperative_complications:_the_first_international_randomized_controlled_trial_for_multimodal_prehabilitation_ L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-5232-6 DB - PRIME DP - Unbound Medicine ER -