Daniel Steffens1,2, Jane Young3,4,5, Paula R Beckenkamp6, James Ratcliffe7, Freya Rubie7, Nabila Ansari3, Neil Pillinger4,8, Cherry Koh3, Phillip A Munoz6,9, Michael Solomon3,4,5. 1. Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital (RPAH), Missenden Road, Camperdown, New South Wales, 2050, Australia. Daniel.Steffens@health.nsw.gov.au. 2. Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Building 89, Leval 9, Missenden Road, Camperdown, New South Wales, 2006, Australia. Daniel.Steffens@health.nsw.gov.au. 3. Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital (RPAH), Missenden Road, Camperdown, New South Wales, 2050, Australia. 4. Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Building 89, Leval 9, Missenden Road, Camperdown, New South Wales, 2006, Australia. 5. Institiute of Academic Surgery (IAS), Royal Prince Alfred Hospital, 145-147 Missenden Road, Camperdown, New South Wales, 2050, Australia. 6. Faculty of Medicine and Health, School of Health Sciences, The University of Sydney, Lidcombe, New South Wales, 2141, Australia. 7. Department of Physiotherapy, Royal Prince Alfred Hospital, Camperdown, New South Wales, 2006, Australia. 8. Department of Anaesthetics, Royal Prince Alfred Hospital, Camperdown, New South Wales, 2006, Australia. 9. Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, New South Wales, 2006, Australia.
Abstract
OBJECTIVE: To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial. DESIGN: Pilot randomized controlled trial. SETTING: Royal Prince Alfred Hospital, Sydney, Australia. SUBJECTS: We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the participating gastrointestinal surgeon at least 2 weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded. METHODS: Participants were randomized to a 2-6 weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital. RESULTS: Of 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63 years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups. CONCLUSIONS: The results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs. TRIAL REGISTRATION: ACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true.
RCT Entities:
OBJECTIVE: To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial. DESIGN: Pilot randomized controlled trial. SETTING: Royal Prince Alfred Hospital, Sydney, Australia. SUBJECTS: We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the participating gastrointestinal surgeon at least 2 weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded. METHODS:Participants were randomized to a 2-6 weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital. RESULTS: Of 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63 years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups. CONCLUSIONS: The results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs. TRIAL REGISTRATION: ACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true.
Entities:
Keywords:
Acceptability; Cancer; Feasibility; Pilot randomized controlled trial; Preoperative exercise; Surgery
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