http://informahealthcare.com/sju ISSN: 2168-1805 (print), 2168-1813 (electronic) Scand J Urol, 2014; 49(2): 133–141 2014 Informa Healthcare. DOI: 10.3109/21681805.2014.967810
ORIGINAL ARTICLE
Efficacy of a multiprofessional rehabilitation programme in radical cystectomy pathways: A prospective randomized controlled trial Bente Thoft Jensen1,2, Annemette Krintel Petersen2,3, Jørgen Bjerggaard Jensen1,2, Sussie Laustsen2,4 and Michael Borre1,2 1
Departments of Urology, 3Physiotherapy and Occupational Therapy, and, 4Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark, and 2Institute of Clinical Medicine & Center of Research in Rehabilitation, Aarhus University, Denmark
Abstract
Key Words:
Introduction. Radical cystectomy with lymph-node dissection is a complex procedure and often followed by high postoperative morbidity and physical impairments leading to prolonged length of stay (LOS). Fast-track principles are standard procedure in radical cystectomy. Additional preoperative and postoperative physical exercises and enhanced mobilization may reduce LOS and early complications. Materials and methods. In total, 107 patients were included in a prospective randomized controlled design, 50 in the intervention group (nI = 50) and 57 in the standard group (ns = 57). The standard regimen comprised regular fast-track principles. The intervention included standardized preoperative and postoperative strength and endurance exercises and progressive postoperative mobilization. The programme was initiated 2 weeks before surgery. Efficacy was expressed as a reduction in postoperative LOS. Early complications were defined as events occurring at most 90 days postoperatively and graded using the Clavien–Dindo classification system. Results. Adherence to prehabilitation, i.e. patients who accomplished at least 75% of the programme, was 59%. Postoperative mobilization was significantly improved by walking distance (p £ 0.001). The ability to perform personal activities of daily living was improved by 1 day (p £ 0.05). The median LOS was 8 days in both treatment groups (p = 0.68). There was no significant difference between treatment groups in severity of complications (p = 0.64). Conclusions. There was no reduction in LOS due to the preoperative and postoperative rehabilitation programme, although enhanced mobilization was achieved. The optimized minimal surgical procedure may have affected the ability to reduce LOS further with available techniques and procedures. Alternative parameters for recovery may offer more precise and relevant information.
bladder cancer, complication, enhanced recovery programme, physical exercise, prehabilitation, radical cystectomy, rehabilitation
Introduction Radical cystectomy (RC) with lymph-node dissection remains the standard treatment for localized muscle-invasive bladder cancer and high-risk non-invasive bladder cancer [1]. RC is a complex procedure that is followed by stress-induced catabolism, impaired organ function, a reduced level of physical activity and malnutrition [2]. Perioperative complications are reported in up to 64% in centres of excellence [3] and often followed by a prolonged length of stay (LOS) [4]. The introduction of multidisciplinary fast-track surgery and enhanced recovery programmes has played a key role in general surgery during the past two decades. Fast-track surgery is a concept of multifaceted approaches aiming to maintain physiological function, reducing the surgical stress response and postoperative morbidity, to accelerate early recovery and to improve patient outcome [5–7]. Fast-track intervention comprises key components involving all three phases of care: preoperative (assessment, preoperative patient education and information), intraoperative (minimally invasive surgery, Correspondence: B. Thoft Jensen, Department of Urology/Clinical Medicine, Center of Research in Rehabilitation, Aarhus University, Brendstrupgaardsvej 100, DK-8200 Aarhus N, Denmark. Tel: +45 21400299. Fax: +45 78522734. E-mail: [email protected]
History Received 28 February 2014 Revised 18 June 2014 Accepted 1 September 2014
standardized anaesthetic) and postoperative (enhanced postoperative mobilization, early oral nutrition, effective pain relief) [5,6]. This concept has been proven effective with respect to increased survival, reduced LOS, reduced morbidity and lower costs, although evidence is mainly derived from colorectal surgery [5]. A recent meta-analysis across surgical specialities has shown the efficacy of fast-track programmes in reducing LOS and early complications within 30 days [5]. Reports from surgical societies on the implementation of fasttrack interventions in major urological surgery are lacking, although recent studies have challenged innovative pathways [7,8]. The exact nature of the successful fast-track intervention in RC may be difficult to define. Programmes with more components are no more successful than those with fewer components [5]. However, early studies including enhanced protocols in RC have improved elements of postoperative care and reported benefits in LOS [9]. Although physical interventions are involved in surgical oncology they are not reported in RC [7]. The introduction of prehabilitation programmes has enhanced the recovery of non-malignant patients and of patients with chronic diseases [10]. However, the current evidence in oncology surgical care is limited by variability in the exercise interventions,
134 B. T. Jensen et al.
Scand J Urol, 2015; 49(2): 133–141
oncology procedure, duration and follow-up, and the implications for overall recovery following RC are unknown [10– 12]. The aims of this study were to evaluate whether preoperative and postoperative physical exercises and enhanced mobilization could reduce LOS and early complications.
Methods Trial design The study design was a prospective randomized controlled clinical trial. It was approved by the Danish Regional Ethics Committee and conformed to the Helsinki Declaration. The study was registered in the Clinical Trials.gov database (reference number M20100122) and data sampling was approved by the Danish Data Protection Agency (number 2010-41-4306). The study was reported in concordance with the CONSORT statement [13].
Aarhus University Hospital in Denmark were assessed for eligibility. Patients with mental or cognitive disorders, or who had been referred because of voiding dysfunctions or neuromuscular diseases, were excluded. As a result, 15 patients did not meet the inclusion criteria; an additional 14 patients declined to participate in the study (Figure 1). In total, 129 patients were randomized to receive intervention or standard treatment. However, following randomization, 22 patients were rediagnosed or reconsidered their choice of treatment, leaving 50 patients in the intervention group (nI = 50) and 57 patients in the standard group (ns = 57) (Figure 1). When scheduled for surgery, the patients underwent a two-, four- or six-block web-based block randomization, externally provided by the Institute of Health of Aarhus University. The staff and investigators were blinded to the process. After receiving written and verbal information, all the patients signed informed consent forms.
Standard treatment Setting and participants All patients (n = 158) scheduled for RC owing to localized muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer from May 2011 to February 2013 at
General fast-track principles were standard procedure in the department (Table 1) [6]. A minilaparotomy RC or robotassisted RC was performed based on the department capacity or patient characteristics. In male patients, RC included
Assessed for eligibility (n = 158)
Enrolment
Excluded (n = 29) Did not fulfil inclusion criteria (n = 11, time factor) Declined to participate (n = 14) Time factor (n = 4)
Allocation
Randomized (n = 129)
Allocated to intervention (n = 65)
Allocated to standard treatment (n = 64)
Recevied allocated regime (n = 50)
Received allocated regime (n = 57)
Did not receive allocated treatment (÷ cystectomy n = 15) Advanced disease (n = 8) Conservative treatment (n = 1) Withdrew (n = 3) Reconsidered patient choice (n = 3)
Did not receive allocated treatment (÷ cystectomy n = 7) Conservative treatment (n = 2) Withdrew (n = 2) Reconsidered patient choice (n = 3)
Surgery-intention-to-treat population (n = 107)
Analysis
Intervention (nI = 50)
Standard (nS = 57)
Discontinued intervention (n = 3)
Discontinued standard treatment (n = 4)
Multiple complications (n = 3) Death < 7 days postoperative (n = 1) Death < 120 days postoperative (n = 2)
Multiple complications (n = 4) Death < 7 days postoperative (n = 3) Death < 120 days postoperative (n = 1)
Per protocol population (n = 100) Intervention (n = 47)
Standard (n = 53)
Figure 1. CONSORT flowchart [13].
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DOI: 10.3109/21681805.2014.967810
135
Table 1. Exercise-based physical rehabilitation programme. Preoperative outpatient optimization from inclusion to surgery (–14 days) Information Information about standard goals for patient involvement concerning mobilization, exercise training and managing urinary diversion Standardized information about the interactions among lifestyle, nutritional status and physical activity Provision of supplementary written information Discussion of mutual expectations and motivation
Exercise-based prehabilitation programme A standardized written exercise programme was introduced and distributed by the MDT-physical therapist. Patients were instructed to perform the exercise training programme twice daily The exercise programme included the following: Step training on a step trainer (15 min per training session); the step trainer was delivered from the hospital Six different muscle strength and endurance exercises The number of repetitions was individualized, and patients were encouraged to progress through the training programme by increasing the number of exercise repetitions A patient diary was distributed, and patients were instructed to record the number of training sessions and number of exercise repetitions daily Evaluation Follow-up A proactive telephone call after 1 week to ensure adherence to the programme In case of questions, patients could contact the MDT
Postoperative in-hospital optimization (day 0–7+) Mobilization Instructions for getting out of bed Aggressive and progressive standardized mobilization plans, including: Scheduled time out of bed increasing from 3 h on day one after surgery to 8 h on the fourth postoperative day Walking distance increasing from 125 m on the day after surgery to 1000 m on the fourth postoperative day Encouragement to follow fixed standard goals for mobilization and walking Registration of daily mobilization and walking activities in a patient diary Evaluation of ability to perform personal activities of daily living with the Katz score Exercise-based rehabilitation programme Physical therapy was provided twice per day for the first 7 postoperative days The physical therapy sessions included the following: Respiratory and circulatory exercises Supervised standardized progressive muscle strength and endurance training Evaluation
Follow-up Discharged with a home training exercise programme In case of questions, patients could contact the MDT
MDT = Multi-diciplinary Team.
removal of the prostate and seminal vesicles. In female patients, RC included the removal of the internal female genitalia. Lymph-node dissection extending to the bifurcation of the aorta was performed at the time of RC [14]. The choice of urinary diversion was based on each patient’s characteristics and preferences. The patients fasted beginning at midnight and were offered fruit juice 4 h before surgery [15]. Infection prophylaxis was administered [15], and venous thromboembolism prophylaxis was provided postsurgery [16]. All the patients received standardized anaesthesia and analgesia throughout the perioperative period. Analgesia within the first 72 h postoperatively was achieved using a Subfascial Pain-Buster device [17]. Oral paracetamol was given for peripheral pain treatment and oxycodone hydrochloride was offered if necessary. Early postoperative nutritional intake was encouraged in accordance with the national RC guidelines [18]; if not successful, parenteral supplementation was initiated. Postoperative mobilization was encouraged in every ward shift as a standard procedure (Table 2).
preoperative and postoperative exercises and enhanced postoperative mobilization (Table 1). A team of three specialized physiotherapists conducted all sessions during the entire study period.
Intervention
Measurements
The intervention group received standard fast-track and an exercise-based intervention that involved standardized
All patients underwent the same demographic and clinical assessments at baseline. The preoperative comorbid status
Prehabilitation. The intervention was initiated 2 weeks before surgery. The physiotherapist introduced a home-based daily exercise programme consisting of endurance and strength exercises with repetitions, and provided instruction for patients. A step-trainer was provided for home use. Patients were encouraged to perform both activities twice a day. Daily achievements were documented by the patient in a personal diary. Posthabilitation. A progressive exercise programme was supervised twice a day (2 30 min) by the physiotherapist and documented in dairies. Enhanced mobilization was defined by everyday goals concerning walking distance and hours out of bed.
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Scand J Urol, 2015; 49(2): 133–141
Table 2. Standard fast-track pathway.
Preoperative (2 weeks before surgery)
Perioperative
Postoperative
Discharge
Intervention fast-track
Standard fast-track
(n 50)
(n 57)
Prehabilitation (exercise programme) + standard fast-track treatment
Nutritional screening and counselling; supportive oral supplements when recommended
Infection prophylaxis (single doses) Minilaparotomy or robot-assisted radical cystectomy Standardized anaesthesia and analgesia throughout surgery using Sevofluran (sedative) and Bupivacaine and Ultiva for pain management Posthabilitation (exercise programme and enhanced mobilization) + standard fast-track treatment
Patient education; lifestyle issues (alcohol, smoking) and postoperative care Optimizing comorbid conditions Counselling on choice of urinary diversion The evening before surgery, the rectal ampulla was emptied Fasting from midnight: carbohydrate loading 4 h before surgery Infection prophylaxis (single doses) Minilaparotomy or robot-assisted radical cystectomy Standardized anaesthesia and analgesia throughout surgery using Sevofluran (sedative) and Bupivacaine and Ultiva for pain management Analgesia within the first 72 h: subfascial Pain-Buster providing continuous infusion of bupivacaine. Peripheral pain treatment: oral paracetamol Prevention of nausea Thromboembolism prophylaxis: compression stockings and Fragmin injections Early oral intake: daily goals: minimum 6300 kJ, protein 1.2 g/kg including oral supplements Standard mobilization: walking activity in every wardshift and supervised by a physiotherapist once a day Early removal of intravenous and urinary catheters
Standardized discharge criteria
and nutritional risk were measured using the age-adjusted Charlson Comorbidity Index Score [19] and the Nutritional Risk Screening (NRS-2002) tool [20]. Nutritional intake was recorded 2 weeks before surgery and during hospitalization, and the daily intake of protein and food energy (kJ) was calculated. Adherence to the prehabilitation intervention was measured according to Table 1 [21]. To determine whether the intervention had an effect on physical activity, the level of mobilization, expressed as “hours out of bed”, and the walking distance in metres (m) were recorded in patient dairies. The exact distance was carefully marked in certain areas of the hospital and in the ward. The ability to independently perform personal activities of daily living (PADL) was evaluated daily using the validated Katz index score, consisting of six self-care skills [22]. Habitual bowel function was measured with the Bristol Scale [23]. The time to restored bowel function was reported as the number of postoperative days before bowel function was restored. Symptoms of pain and nausea were measured using a visual analogue scale at baseline and daily before and after any activity [24]. Owing to the nature of multiprofessional interventions in clinical practice, the staff were not blinded to the allocation. Achievements were documented by the study nurse and the staff. To secure a uniform discharge the following standard criteria were applied: the ability to perform all six PADL elements, a nutritional intake of at least 6300 kJ per day, achievement of 70% of the physical activity according to standardized postoperative goals, the need for oral
medication only, medical stabilization and the restoration of bowel function. A potential need for supportive care with the urinary diversion did not hinder discharge. If the patient was not discharged as early as the criteria allowed, the reason for the delay was recorded. Early complications, within 90 days postoperatively, were defined according to the Memorial Sloan Kettering standard system for reporting complications [3]. Data were collected from the following sources: prospective personal interviews with the patients, electronic medical records and at follow-up visits conducted by the study nurse. The severity of complications was graded using the Clavien–Dindo system [25]. Patients with more than one complication were graded by the most serious event. Potential risk factors were reported preoperatively (Table 2). Any incidents of readmission within 30 days of discharge and patient deaths (and causes) were monitored. None of the patients was lost to follow-up. Endpoint and secondary outcomes The primary endpoint was LOS, defined as the number of postoperative days from surgery until discharge. Timely LOS was defined as the number of days until the discharge criteria were fulfilled. The secondary outcomes were the number of incidents and severity of complications, rate of hospital readmissions within 30 days of discharge and mortality. Other clinical indicators were the time to restored bowel function, postoperative pain, the duration of the surgical procedure and the need for blood transfusion.
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DOI: 10.3109/21681805.2014.967810
137
Table 3. Clinical and demographic covariates of 107 patients undergoing radical cystectomy at Aarhus University Hospital, Denmark, 2011–2013.
Gender Male, n (%) Female, n (%) Age (years) Mean (95% CI) Range Maximum tumour stage, n (%) T1 T2 T3 T4a pN-stadia N0 N-pos Nx Urinary diversion, n (%) Ileal conduit Orthotopic neobladder Continent cutaneous reservoir Surgical procedure, n (%) Open surgery Robot-assisted Time (min) for surgical procedure Open surgery, mean (95% CI) Robot-assisted, mean (95% CI) Transf. Pack SAGM, mean (95% CI) Pain (VAS 1–10) 0 1–3 4–5 ‡6 Comorbidity Index Score, n (%)a No 1–2 Low 3–4 High ‡5 Severe Nutritional Risk Score (NRS-2002), n (%) ‡3 “at risk”
ORIGINAL ARTICLE
Efficacy of a multiprofessional rehabilitation programme in radical cystectomy pathways: A prospective randomized controlled trial Bente Thoft Jensen1,2, Annemette Krintel Petersen2,3, Jørgen Bjerggaard Jensen1,2, Sussie Laustsen2,4 and Michael Borre1,2 1
Departments of Urology, 3Physiotherapy and Occupational Therapy, and, 4Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark, and 2Institute of Clinical Medicine & Center of Research in Rehabilitation, Aarhus University, Denmark
Abstract
Key Words:
Introduction. Radical cystectomy with lymph-node dissection is a complex procedure and often followed by high postoperative morbidity and physical impairments leading to prolonged length of stay (LOS). Fast-track principles are standard procedure in radical cystectomy. Additional preoperative and postoperative physical exercises and enhanced mobilization may reduce LOS and early complications. Materials and methods. In total, 107 patients were included in a prospective randomized controlled design, 50 in the intervention group (nI = 50) and 57 in the standard group (ns = 57). The standard regimen comprised regular fast-track principles. The intervention included standardized preoperative and postoperative strength and endurance exercises and progressive postoperative mobilization. The programme was initiated 2 weeks before surgery. Efficacy was expressed as a reduction in postoperative LOS. Early complications were defined as events occurring at most 90 days postoperatively and graded using the Clavien–Dindo classification system. Results. Adherence to prehabilitation, i.e. patients who accomplished at least 75% of the programme, was 59%. Postoperative mobilization was significantly improved by walking distance (p £ 0.001). The ability to perform personal activities of daily living was improved by 1 day (p £ 0.05). The median LOS was 8 days in both treatment groups (p = 0.68). There was no significant difference between treatment groups in severity of complications (p = 0.64). Conclusions. There was no reduction in LOS due to the preoperative and postoperative rehabilitation programme, although enhanced mobilization was achieved. The optimized minimal surgical procedure may have affected the ability to reduce LOS further with available techniques and procedures. Alternative parameters for recovery may offer more precise and relevant information.
bladder cancer, complication, enhanced recovery programme, physical exercise, prehabilitation, radical cystectomy, rehabilitation
Introduction Radical cystectomy (RC) with lymph-node dissection remains the standard treatment for localized muscle-invasive bladder cancer and high-risk non-invasive bladder cancer [1]. RC is a complex procedure that is followed by stress-induced catabolism, impaired organ function, a reduced level of physical activity and malnutrition [2]. Perioperative complications are reported in up to 64% in centres of excellence [3] and often followed by a prolonged length of stay (LOS) [4]. The introduction of multidisciplinary fast-track surgery and enhanced recovery programmes has played a key role in general surgery during the past two decades. Fast-track surgery is a concept of multifaceted approaches aiming to maintain physiological function, reducing the surgical stress response and postoperative morbidity, to accelerate early recovery and to improve patient outcome [5–7]. Fast-track intervention comprises key components involving all three phases of care: preoperative (assessment, preoperative patient education and information), intraoperative (minimally invasive surgery, Correspondence: B. Thoft Jensen, Department of Urology/Clinical Medicine, Center of Research in Rehabilitation, Aarhus University, Brendstrupgaardsvej 100, DK-8200 Aarhus N, Denmark. Tel: +45 21400299. Fax: +45 78522734. E-mail: [email protected]
History Received 28 February 2014 Revised 18 June 2014 Accepted 1 September 2014
standardized anaesthetic) and postoperative (enhanced postoperative mobilization, early oral nutrition, effective pain relief) [5,6]. This concept has been proven effective with respect to increased survival, reduced LOS, reduced morbidity and lower costs, although evidence is mainly derived from colorectal surgery [5]. A recent meta-analysis across surgical specialities has shown the efficacy of fast-track programmes in reducing LOS and early complications within 30 days [5]. Reports from surgical societies on the implementation of fasttrack interventions in major urological surgery are lacking, although recent studies have challenged innovative pathways [7,8]. The exact nature of the successful fast-track intervention in RC may be difficult to define. Programmes with more components are no more successful than those with fewer components [5]. However, early studies including enhanced protocols in RC have improved elements of postoperative care and reported benefits in LOS [9]. Although physical interventions are involved in surgical oncology they are not reported in RC [7]. The introduction of prehabilitation programmes has enhanced the recovery of non-malignant patients and of patients with chronic diseases [10]. However, the current evidence in oncology surgical care is limited by variability in the exercise interventions,
134 B. T. Jensen et al.
Scand J Urol, 2015; 49(2): 133–141
oncology procedure, duration and follow-up, and the implications for overall recovery following RC are unknown [10– 12]. The aims of this study were to evaluate whether preoperative and postoperative physical exercises and enhanced mobilization could reduce LOS and early complications.
Methods Trial design The study design was a prospective randomized controlled clinical trial. It was approved by the Danish Regional Ethics Committee and conformed to the Helsinki Declaration. The study was registered in the Clinical Trials.gov database (reference number M20100122) and data sampling was approved by the Danish Data Protection Agency (number 2010-41-4306). The study was reported in concordance with the CONSORT statement [13].
Aarhus University Hospital in Denmark were assessed for eligibility. Patients with mental or cognitive disorders, or who had been referred because of voiding dysfunctions or neuromuscular diseases, were excluded. As a result, 15 patients did not meet the inclusion criteria; an additional 14 patients declined to participate in the study (Figure 1). In total, 129 patients were randomized to receive intervention or standard treatment. However, following randomization, 22 patients were rediagnosed or reconsidered their choice of treatment, leaving 50 patients in the intervention group (nI = 50) and 57 patients in the standard group (ns = 57) (Figure 1). When scheduled for surgery, the patients underwent a two-, four- or six-block web-based block randomization, externally provided by the Institute of Health of Aarhus University. The staff and investigators were blinded to the process. After receiving written and verbal information, all the patients signed informed consent forms.
Standard treatment Setting and participants All patients (n = 158) scheduled for RC owing to localized muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer from May 2011 to February 2013 at
General fast-track principles were standard procedure in the department (Table 1) [6]. A minilaparotomy RC or robotassisted RC was performed based on the department capacity or patient characteristics. In male patients, RC included
Assessed for eligibility (n = 158)
Enrolment
Excluded (n = 29) Did not fulfil inclusion criteria (n = 11, time factor) Declined to participate (n = 14) Time factor (n = 4)
Allocation
Randomized (n = 129)
Allocated to intervention (n = 65)
Allocated to standard treatment (n = 64)
Recevied allocated regime (n = 50)
Received allocated regime (n = 57)
Did not receive allocated treatment (÷ cystectomy n = 15) Advanced disease (n = 8) Conservative treatment (n = 1) Withdrew (n = 3) Reconsidered patient choice (n = 3)
Did not receive allocated treatment (÷ cystectomy n = 7) Conservative treatment (n = 2) Withdrew (n = 2) Reconsidered patient choice (n = 3)
Surgery-intention-to-treat population (n = 107)
Analysis
Intervention (nI = 50)
Standard (nS = 57)
Discontinued intervention (n = 3)
Discontinued standard treatment (n = 4)
Multiple complications (n = 3) Death < 7 days postoperative (n = 1) Death < 120 days postoperative (n = 2)
Multiple complications (n = 4) Death < 7 days postoperative (n = 3) Death < 120 days postoperative (n = 1)
Per protocol population (n = 100) Intervention (n = 47)
Standard (n = 53)
Figure 1. CONSORT flowchart [13].
Rehabilitation in radical cystectomy
DOI: 10.3109/21681805.2014.967810
135
Table 1. Exercise-based physical rehabilitation programme. Preoperative outpatient optimization from inclusion to surgery (–14 days) Information Information about standard goals for patient involvement concerning mobilization, exercise training and managing urinary diversion Standardized information about the interactions among lifestyle, nutritional status and physical activity Provision of supplementary written information Discussion of mutual expectations and motivation
Exercise-based prehabilitation programme A standardized written exercise programme was introduced and distributed by the MDT-physical therapist. Patients were instructed to perform the exercise training programme twice daily The exercise programme included the following: Step training on a step trainer (15 min per training session); the step trainer was delivered from the hospital Six different muscle strength and endurance exercises The number of repetitions was individualized, and patients were encouraged to progress through the training programme by increasing the number of exercise repetitions A patient diary was distributed, and patients were instructed to record the number of training sessions and number of exercise repetitions daily Evaluation Follow-up A proactive telephone call after 1 week to ensure adherence to the programme In case of questions, patients could contact the MDT
Postoperative in-hospital optimization (day 0–7+) Mobilization Instructions for getting out of bed Aggressive and progressive standardized mobilization plans, including: Scheduled time out of bed increasing from 3 h on day one after surgery to 8 h on the fourth postoperative day Walking distance increasing from 125 m on the day after surgery to 1000 m on the fourth postoperative day Encouragement to follow fixed standard goals for mobilization and walking Registration of daily mobilization and walking activities in a patient diary Evaluation of ability to perform personal activities of daily living with the Katz score Exercise-based rehabilitation programme Physical therapy was provided twice per day for the first 7 postoperative days The physical therapy sessions included the following: Respiratory and circulatory exercises Supervised standardized progressive muscle strength and endurance training Evaluation
Follow-up Discharged with a home training exercise programme In case of questions, patients could contact the MDT
MDT = Multi-diciplinary Team.
removal of the prostate and seminal vesicles. In female patients, RC included the removal of the internal female genitalia. Lymph-node dissection extending to the bifurcation of the aorta was performed at the time of RC [14]. The choice of urinary diversion was based on each patient’s characteristics and preferences. The patients fasted beginning at midnight and were offered fruit juice 4 h before surgery [15]. Infection prophylaxis was administered [15], and venous thromboembolism prophylaxis was provided postsurgery [16]. All the patients received standardized anaesthesia and analgesia throughout the perioperative period. Analgesia within the first 72 h postoperatively was achieved using a Subfascial Pain-Buster device [17]. Oral paracetamol was given for peripheral pain treatment and oxycodone hydrochloride was offered if necessary. Early postoperative nutritional intake was encouraged in accordance with the national RC guidelines [18]; if not successful, parenteral supplementation was initiated. Postoperative mobilization was encouraged in every ward shift as a standard procedure (Table 2).
preoperative and postoperative exercises and enhanced postoperative mobilization (Table 1). A team of three specialized physiotherapists conducted all sessions during the entire study period.
Intervention
Measurements
The intervention group received standard fast-track and an exercise-based intervention that involved standardized
All patients underwent the same demographic and clinical assessments at baseline. The preoperative comorbid status
Prehabilitation. The intervention was initiated 2 weeks before surgery. The physiotherapist introduced a home-based daily exercise programme consisting of endurance and strength exercises with repetitions, and provided instruction for patients. A step-trainer was provided for home use. Patients were encouraged to perform both activities twice a day. Daily achievements were documented by the patient in a personal diary. Posthabilitation. A progressive exercise programme was supervised twice a day (2 30 min) by the physiotherapist and documented in dairies. Enhanced mobilization was defined by everyday goals concerning walking distance and hours out of bed.
136 B. T. Jensen et al.
Scand J Urol, 2015; 49(2): 133–141
Table 2. Standard fast-track pathway.
Preoperative (2 weeks before surgery)
Perioperative
Postoperative
Discharge
Intervention fast-track
Standard fast-track
(n 50)
(n 57)
Prehabilitation (exercise programme) + standard fast-track treatment
Nutritional screening and counselling; supportive oral supplements when recommended
Infection prophylaxis (single doses) Minilaparotomy or robot-assisted radical cystectomy Standardized anaesthesia and analgesia throughout surgery using Sevofluran (sedative) and Bupivacaine and Ultiva for pain management Posthabilitation (exercise programme and enhanced mobilization) + standard fast-track treatment
Patient education; lifestyle issues (alcohol, smoking) and postoperative care Optimizing comorbid conditions Counselling on choice of urinary diversion The evening before surgery, the rectal ampulla was emptied Fasting from midnight: carbohydrate loading 4 h before surgery Infection prophylaxis (single doses) Minilaparotomy or robot-assisted radical cystectomy Standardized anaesthesia and analgesia throughout surgery using Sevofluran (sedative) and Bupivacaine and Ultiva for pain management Analgesia within the first 72 h: subfascial Pain-Buster providing continuous infusion of bupivacaine. Peripheral pain treatment: oral paracetamol Prevention of nausea Thromboembolism prophylaxis: compression stockings and Fragmin injections Early oral intake: daily goals: minimum 6300 kJ, protein 1.2 g/kg including oral supplements Standard mobilization: walking activity in every wardshift and supervised by a physiotherapist once a day Early removal of intravenous and urinary catheters
Standardized discharge criteria
and nutritional risk were measured using the age-adjusted Charlson Comorbidity Index Score [19] and the Nutritional Risk Screening (NRS-2002) tool [20]. Nutritional intake was recorded 2 weeks before surgery and during hospitalization, and the daily intake of protein and food energy (kJ) was calculated. Adherence to the prehabilitation intervention was measured according to Table 1 [21]. To determine whether the intervention had an effect on physical activity, the level of mobilization, expressed as “hours out of bed”, and the walking distance in metres (m) were recorded in patient dairies. The exact distance was carefully marked in certain areas of the hospital and in the ward. The ability to independently perform personal activities of daily living (PADL) was evaluated daily using the validated Katz index score, consisting of six self-care skills [22]. Habitual bowel function was measured with the Bristol Scale [23]. The time to restored bowel function was reported as the number of postoperative days before bowel function was restored. Symptoms of pain and nausea were measured using a visual analogue scale at baseline and daily before and after any activity [24]. Owing to the nature of multiprofessional interventions in clinical practice, the staff were not blinded to the allocation. Achievements were documented by the study nurse and the staff. To secure a uniform discharge the following standard criteria were applied: the ability to perform all six PADL elements, a nutritional intake of at least 6300 kJ per day, achievement of 70% of the physical activity according to standardized postoperative goals, the need for oral
medication only, medical stabilization and the restoration of bowel function. A potential need for supportive care with the urinary diversion did not hinder discharge. If the patient was not discharged as early as the criteria allowed, the reason for the delay was recorded. Early complications, within 90 days postoperatively, were defined according to the Memorial Sloan Kettering standard system for reporting complications [3]. Data were collected from the following sources: prospective personal interviews with the patients, electronic medical records and at follow-up visits conducted by the study nurse. The severity of complications was graded using the Clavien–Dindo system [25]. Patients with more than one complication were graded by the most serious event. Potential risk factors were reported preoperatively (Table 2). Any incidents of readmission within 30 days of discharge and patient deaths (and causes) were monitored. None of the patients was lost to follow-up. Endpoint and secondary outcomes The primary endpoint was LOS, defined as the number of postoperative days from surgery until discharge. Timely LOS was defined as the number of days until the discharge criteria were fulfilled. The secondary outcomes were the number of incidents and severity of complications, rate of hospital readmissions within 30 days of discharge and mortality. Other clinical indicators were the time to restored bowel function, postoperative pain, the duration of the surgical procedure and the need for blood transfusion.
Rehabilitation in radical cystectomy
DOI: 10.3109/21681805.2014.967810
137
Table 3. Clinical and demographic covariates of 107 patients undergoing radical cystectomy at Aarhus University Hospital, Denmark, 2011–2013.
Gender Male, n (%) Female, n (%) Age (years) Mean (95% CI) Range Maximum tumour stage, n (%) T1 T2 T3 T4a pN-stadia N0 N-pos Nx Urinary diversion, n (%) Ileal conduit Orthotopic neobladder Continent cutaneous reservoir Surgical procedure, n (%) Open surgery Robot-assisted Time (min) for surgical procedure Open surgery, mean (95% CI) Robot-assisted, mean (95% CI) Transf. Pack SAGM, mean (95% CI) Pain (VAS 1–10) 0 1–3 4–5 ‡6 Comorbidity Index Score, n (%)a No 1–2 Low 3–4 High ‡5 Severe Nutritional Risk Score (NRS-2002), n (%) ‡3 “at risk”
