Two novel prehabilitation apps to help patients stop smoking and risky drinking prior to hip and knee arthroplasty.

PURPOSE: Daily smoking or risky drinking increases the risk of complications after surgery by ~50%. Intensive prehabilitation aimed at complete cessation reduces the complication rate but is time-consuming. The purpose of this study was to carry out preoperative pilot tests (randomized design) of the feasibility (1A) and validation (1B) of two novel prehabilitation apps, habeat® (Ha-app) or rehaviour® (Re-app). METHODS: Patients scheduled for hip or knee arthroplasty with daily smoking, risky drinking, or both were randomised to one of the two apps. In part 1A, eight patients and their staff measured feasibility on a visual analog scale (VAS) and were interviewed about what worked well and the challenges requiring improvement. In part 1B, seven patients and their staff tested the improved apps for up to two weeks before validating the understanding, usability, coverage, and empowerment on a VAS and being interviewed. RESULTS: In 1A, all patients and staff returned scores of ≥5 for understanding the apps and mostly suggested technical improvements. In 1B, the scores varied widely for both apps, with no consensus achieved. Two of four patients (Ha-app) and one-third of the patients (Re-app) found the apps helpful for reducing smoking, but without successful quitting. The staff experienced low app competencies among patients and high time consumption. Specifically, patients most often needed help for the Ha-app, and the staff most often for Re-app; however, the staff reported the Re-app dashboard was more user-friendly. Support and follow-up from an addiction specialist staff member were suggested to complement the apps, thereby increasing the time consumption for staff. CONCLUSIONS: This pilot study to test prototype apps generated helpful feedback for the app developers. Based on the patient and staff comments, multiple improvements in functionality seem required before scaling up the evaluation for effect on prehabilitation and postoperative complications.

Smoking and alcohol cessation intervention in relation to radical cystectomy: a qualitative study of cancer patients' experiences.

BACKGROUND: Despite smoking and risky alcohol drinking being modifiable risk factors for cancer as well as postoperative complications, perioperative cessation counselling is often ignored. Little is known about how cancer patients experience smoking and alcohol interventions in relation to surgery. Therefore the aim of this study was to explore how bladder cancer patients experience a perioperative smoking and alcohol cessation intervention in relation to radical cystectomy. METHODS: A qualitative study was conducted in two urology out-patient clinics. We conducted semi-structured in-depth interviews with 11 purposively sampled persons who had received the smoking and alcohol cessation intervention. The analysis followed the steps contained in the thematic network analysis. RESULTS: Two global themes emerged: "smoking and alcohol cessation was experienced as an integral part of bladder cancer surgery" and "returning to everyday life was a barrier for continued smoking cessation/alcohol reduction". Participants described that during hospitalization their focus shifted to the operation and they did not experience craving to smoke or drink alcohol. Concurrent with improved well-being or experiencing stressful situations, the risk of relapse increased when returning to everyday life. CONCLUSIONS: The smoking and alcohol cessation intervention was well received by the participants. Cancer surgery served as a kind of refuge and was a useful cue for motivating patients to quit smoking and to reconsider the consequences of risky drinking. These results adds to the sparse evidence of what supports smoking and alcohol cessation in relation to bladder cancer patients undergoing major surgery and point to the need to educate healthcare professionals in offering smoking and alcohol cessation interventions in hospitals. The study also provides knowledge about the intervention in the STOP-OP study and will help guide the design of future smoking and alcohol cessation studies aimed at cancer patients undergoing surgery.

Emergency Department-Initiated Tobacco Control: Update of a Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: A 2012 systematic review and meta-analysis of randomized controlled trials on emergency department-initiated tobacco control (ETC) showed only short-term efficacy. The aim of this study was to update data through May 2015. METHODS: After registering the study protocol on the international prospective register of systematic reviews (PROSPERO) in May 2015, we searched 7 databases and the gray literature. Our outcome of interest was the point prevalence of tobacco-use abstinence at 1-month, 3-month, 6-month, or 12-month follow-up. We calculated the relative risk (RR) of tobacco-use abstinence after ETC at each follow-up time separately for each study and then pooled Mantel-Haenszel RRs by follow-up time. These results were pooled with results of the 7 studies included in the previous review. We calculated the effect of ETC on the combined point prevalence of tobacco-use abstinence across all follow-up times by using generalized linear mixed models. RESULTS: We retrieved 4 additional studies, one published as an abstract, comprising 1,392 participants overall. The 1-month follow-up point prevalence of tobacco-use abstinence after ETC resulted in an RR of 1.49 (95% confidence interval [CI], 1.08-2.05) across 3 studies; 3-month follow-up, an RR of 1.38 (95% CI, 1.12-1.71) across 9 studies; 6-month follow-up, an RR of 1.09 (95% CI, 0.84-1.41) across 6 studies; and 12-month follow-up, an RR of 1.26 (95% CI, 1.00-1.59) across 3 studies. The effect on the combined point prevalence of abstinence was an RR of 1.40 (95% CI, 1.06-1.86) (P = .02). CONCLUSION: ETC is effective in promoting continual tobacco-use abstinence up to 12 months after intervention. ETC may be a critically important public health strategy for engaging hard-to-reach smokers in tobacco-use cessation.

Identification of Alcohol Use Prior to Major Cancer Surgery: Timeline Follow Back Interview Compared to Four Other Markers.

BACKGROUND: The postoperative complication rate is 30-64% among patients undergoing muscle-invasive and recurrent high-risk non-muscle-invasive bladder cancer surgery. Preoperative risky alcohol use increases the risk. The aim was to evaluate the accuracy of markers for identifying preoperative risky alcohol. METHODS: Diagnostic test sub-study of a randomized controlled trial (STOP-OP trial), based on a cohort of 94 patients scheduled for major bladder cancer surgery. Identification of risky alcohol use using Timeline Follow Back interviews (TLFB) were compared to the AUDIT-C questionnaire and three biomarkers: carbohydrate-deficient transferrin in plasma (P-CDT), phosphatidyl-ethanol in blood (B-PEth), and ethyl glucuronide in urine (U-EtG). RESULTS: The correlation between TLFB and AUDIT-C was strong (ρ = 0.75), while it was moderate between TLFB and the biomarkers (ρ = 0.55-0.65). Overall, sensitivity ranged from 56 to 82% and specificity from 38 to 100%. B-PEth showed the lowest sensitivity at 56%, but the highest specificity of 100%. All tests had high positive predictive values (79-100%), but low negative predictive values (42-55%). CONCLUSIONS: Despite high positive predictive values, negative predictive values were weak compared to TLFB. For now, TLFB interviews seem preferable for preoperative identification of risky alcohol use.

From fast-track to enhanced recovery after surgery in radical cystectomy pathways: A nursing perspective.

Objective: The purpose of this narrative review is to summarize existing knowledge and evidence about the establishment of enhanced recovery after surgery (ERAS) pathways with emphasize on radical cystectomy (RC), and the emerging and prominent role of nursing within the ERAS pathway. The current status of implementation and adherence to ERAS protocol in RC is discussed and the impact on primary outcomes according to ERAS is summarized. Methods: The review was conducted based on a focused search in PubMed and CINAHL. Results: The goal of a modern RC enhanced recovery protocols (ERPs) anno 2022 is to have a positive impact on patient care from diagnosis throughout recovery with focus on the quality, rather than speed, of recovery. This may be more in alignment with the patient's needs and preferences. Conclusions: Nursing has been in the forefront since the establishment of ERAS, and the nurse-coordinator must be skilled in evidence-based medicine and have excellent communicative competencies to support the patient journey. Implementation of ERAS have reduced hospitalization by improved minimal surgery, optimized anesthetic regimes without increasing readmission rates. It is not known which items can reduce post-operative complications. In the future, nurses should seek a more prominent and leading role during the implementation process and take responsibility for continued education of the staff. Likewise, future nursing interventions will focus on early identification of modifiable risk factors, and a deeper exploration of the patients personally needs and preferences to upcoming surgery could optimize adherence throughout the pathway, which may add to positive outcomes.

Intensive versus short face-to-face smoking cessation interventions: a meta-analysis.

OBJECTIVES: To evaluate the efficacy of intensive smoking cessation interventions (ISCIs) directly compared with shorter interventions (SIs), measured as successful quitting. METHOD: Medline, Embase, the Cochrane Library and CINAHL were searched on 15 October 2021. Peer-reviewed randomised controlled trials (RCTs) of adult, daily smokers undergoing an ISCI were included. No setting, time or language restrictions were imposed. Risk of bias and quality of evidence was assessed using the Cochrane tool and Grading of Recommendations, Assessment, Development and Evaluation, respectively. Meta-analyses were conducted using a random-effects model. RESULTS: 17 550 unique articles were identified and 17 RCTs evaluating 9812 smokers were included. 14 studies were conducted in Europe or the USA. The quality of the evidence was assessed as low or moderate. Continuous abstinence was significantly higher in ISCIs in the long term (risk ratio 2.60, 95% CI 1.71-3.97). Direction and magnitude were similar in the short term; however, they were not statistically significant (risk ratio 2.49, 95% CI: 0.94-6.56). When measured as point prevalence, successful quitting was still statistically significant in favour of ISCIs, but lower (long term: 1.64, 1.08-2.47; short term: 1.68, 1.10-2.56). Sensitivity analysis confirmed the robustness of the results. CONCLUSION: ISCIs are highly effective compared to SIs. This important knowledge should be used to avoid additional morbidity and mortality caused by smoking.

STRONG for Surgery & Strong for Life - against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery - a protocol for an RCT with nested interview study (STRONG-Cancer).

BACKGROUND: There is a large unused potential for risk reduction in the preoperative period via effective lifestyle intervention targeting co-existing risky lifestyles: Smoking, malNutrition, obesity, risky Alcohol intake and insufficient Physical activity (SNAP). This trial compares the efficacy of the integrated STRONG programme with standard care on preoperative risk reduction and secondly on SNAP factor improvement and frailty, postoperative complications and quality of life. A nested interview study explores the patient preferences and the multi-perspective view of patients, relatives and health professionals. METHODS: In total, 42 surgical patients with ≥1 SNAP factor are allocated to individually tailored STRONG programme or usual care during adjuvant chemotherapy prior to radical bladder cancer surgery. The STRONG programme has ≥6 weekly sessions with patient education, motivational and pharmaceutical support. It is based on intensive smoking and alcohol cessation interventions reporting perioperative quit rates > 50%. Surgical risk reduction is measured as ≥1 step for 1 or more risky lifestyles on the ASA-score, secondly as having no risky SNAP factors, and as any SNAP improvement. The outcomes are validated by measurements and biomarkers. Postoperative complications are categorised according to the Clavien-Dindo classification. Health-related quality of life is measured by EQ-5D. The patients are followed up after 6 weeks at surgery and 6 weeks and 6 months postoperatively. A representative sample of the participants, their relatives and the clinical staff are interviewed until data saturation. Transcription, triangulated analyses and data management are conducted using NVivo computer software. DISCUSSION: The surgical agenda is characterised by fixed dates for surgery focusing on clear risk reduction within a short time. This requires a clinical useful lifestyle intervention programme with a high effect and coverage as well as containing all SNAP factors and tailored to individual needs. The STRONG programme seems to meet these requirements. After development in multi-professional collaboration, STRONG is delivered by a specially trained nurse as part of the surgical patient journey. Overall, this study will bring important new knowledge about risk reduction in a frail patient group undergoing major cancer surgery. TRIAL REGISTRATION: Registration at www.clintrials.gov ( NCT04088968 ) The manuscript form from https://trialsjournal.biomedcentral.com/bmc/journal and the SPIRIT guidelines are followed.

Efficacy of pre and rehabilitation in radical cystectomy on health related quality of life and physical function: A systematic review.

Objective: The efficacy of prehabilitation or rehabilitation interventions on radical cystectomy (RC) patient reported outcomes (PROs), and patient centered outcome has not yet been thoroughly explored in prior reviews, therefore the aim of this review is to evaluate the efficacy of a single or multi-modal prehabilitation or/and postoperative rehabilitation interventions compared to standard treatment on postoperative complications after RC. Methods: We performed a three-step search strategy in PubMed, Cinahl, Embase, Cochrane Library, and Web of Science. We used Covidence for the screening of articles, risk of bias assessment, and data-extraction. GRADE was used to assess the risk of bias in outcomes across studies. Where meta-analysis was possible, we used the random effect method due to substantial heterogeneity. The remaining outcomes were summarized narratively. Results: We identified fourteen studies addressing one of the outcomes. None of the studies provided evidence to support that prehabilitation and/or rehabilitation interventions can improve global health related quality of life (HRQoL) in RC surgery or can reduce postoperative complications significantly. However, preoperative and postoperative education in stoma care can significantly improve self-efficacy and we found significant added benefits of sexual counseling to intracavernous injections compared to injection therapy alone. Likewise, an intensive smoking and alcohol cessation intervention demonstrated a significant effect on quit rates. Physical exercise is feasible and improves physical functioning although it does not reduce the postoperative complications. Conclusions: Currently, no evidence of efficacy of prehabilitation and/or rehabilitation interventions to improve the overall HRQoL or postoperative complications after RC exists. We found evidence that education in stoma care improved self-efficacy significantly. Adequately powered randomized controlled trials (RCTs) are needed to generate high-quality evidence in this field.

Effect of a Smoking and Alcohol Cessation Intervention Initiated Shortly Before Radical Cystectomy-the STOP-OP Study: A Randomised Clinical Trial.

BACKGROUND: Evidence concerning the reduction of postoperative complications due to smoking and alcohol drinking in patients undergoing radical cystectomy is incomplete. OBJECTIVE: To evaluate the efficacy of a 6-wk smoking and/or alcohol cessation intervention, initiated shortly before surgery and continued until 4 wk after, in reducing complications. DESIGN, SETTING, AND PARTICIPANTS: Between 2014 and 2018, we enrolled 104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial. INTERVENTION: Patients were randomised to a 6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the number of patients developing any postoperative complication, or death, within 30 d after surgery. The secondary endpoints were successful quitters, health-related quality of life, length of stay, time back to habitual activity, and mortality. An intention-to-treat analysis was applied to evaluate treatment effect. RESULTS AND LIMITATIONS: There were some differences in baseline demographic and lifestyle characteristics. Postoperatively, 64% in the intervention group versus 70% in the control group (risk ratio [RR] 0.91, confidence interval [CI] 0.68-1.21, p = 0.51) developed complications. Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18-0.84, p = 0.01). The rates of successful quitting were 51% in the intervention group and 27% in the control group (RR 2, CI 1.14-3.51, p = 0.01). The external validity of this trial may be limited because 53% of eligible patients refused participation. CONCLUSIONS: Despite a significant effect on the quit rate at completion of the intervention, this multimodal prehabilitation did not show a significant difference regarding our primary outcome postoperative complications. PATIENT SUMMARY: A 6-wk smoking and alcohol cessation intervention in relation to bladder cancer surgery did not reduce postoperative complications, but it was effective in supporting people to quit in the short term.

Nursing Implication of People Treated by Radical Cystectomy Postsurgery and Rehabilitation.

OBJECTIVE: The purpose of this paper is to summarize existing evidence about nursing interventions to selected symptoms experienced by patients undergoing radical cystectomy (RC) to maintain or return to their daily life activities. DATA SOURCES: A non-systematic narrative review was conducted. A search in PubMed and CINAHL was conducted eliciting evidence about frequent symptoms experienced after RC. The following search terms were used: radical cystectomy and/or nursing interventions, pain, distress, fatigue, urinary dysfunction, sexual dysfunction, loss of appetite, sleep disturbance, and enhanced recovery after surgery (ERAS). CONCLUSION: Evidence in the ERAS pathway is still lacking regarding the effect of preoperative education and counseling of the patient and the most difficult part to implement is related to preoperative optimization of the patient such as lifestyle changes. Most nursing interventions to alleviate symptoms in the rehabilitation period after RC are still practice based. IMPLICATIONS FOR NURSING PRACTICE: Priority should be given to implementation of the ERAS protocol. To improve the management of symptoms experienced by patients in the RC rehabilitation period it is essential that validated screening tools to identify the symptoms be used. Accepted and effective strategies for treating the individual symptoms should be initiated and clear treatment outcomes should be defined. Urology nurse researchers should investigate the concept of symptom clusters to clarify whether there are more efficient methods to identify symptoms or symptom clusters and if so would the use of symptom clusters knowledge improve patient care.

Perioperative Alcohol and Smoking Cessation Intervention: Impact on Other Lifestyles.

OBJECTIVE: Cigarette smoking and alcohol drinking are preventable risk factors in surgery. It is unknown whether intervening on these two risk factors also have an effect on other lifestyles. Therefore, the primary aim of this study was to compare the effect of an intensive alcohol and smoking cessation intervention on other lifestyles (malnutrition, obesity, and physical inactivity) with treatment as usual, among patients scheduled for radical cystectomy. The secondary aim was to evaluate associations between successful quitting and changes in other lifestyles. DATA SOURCES: Data on 94 patients with bladder cancer undergoing radical cystectomy originated from the STOP-OP study, a randomized intervention trial that enrolled patients from four Danish hospitals. Patients were enrolled between November 2014 and July 2017. CONCLUSION: We found no significant differences regarding the three lifestyle factors; risk of malnutrition, obesity, and physical inactivity between patients in the intervention and standard care at the end of the intervention at 6 weeks, 3 months, 6 months, and 12 months. Also, there were no significant associations between successful quitters and non-quitters for alcohol and smoking and the other three lifestyles; risk of malnutrition, obesity, and physical inactivity. IMPLICATIONS FOR NURSING PRACTICE: Findings from this study show that cancer surgery is a good opportunity to address lifestyle changes and that more research into the effect of multimodal interventions are needed. Guidelines on how to support patients to change lifestyle in relation to surgery should be part of nursing practice.

The Potential of Prehabilitation in Radical Cystectomy Pathways: Where Are We Now?

OBJECTIVE: The growing recognition of prehabilitation has caused an emerging paradigm shift in surgical cancer care and an integrated component of the cancer care continuum. This narrative review aims to update and inform the urological community of the potential of prehabilitation before radical cystectomy. DATA SOURCES: A nonsystematic narrative review was performed through a database search in PubMed, and CINAHL using the following search terms: enhanced recovery after surgery (ERAS); Frailty; Prehabilitation and/or Rehabilitation; Physical Activity and/or exercises; Nutrition; Nutritional Care; Smoking cessation; Alcohol cessation; Prevention; Supportive Care; and combined with Radical Cystectomy. CONCLUSION: A multimodal and multi-professional approach during the preoperative period may offer an opportunity to preserve or enhance physiological integrity and optimize surgical recovery. Studies indicate a positive effect of prehabilitation on postoperative functional capacity and earlier return to daily activities and health related quality of life. Meaningful outcomes that reflect recovery from a patient's perspective and clinical outcome measures, as well as validating metrics, are necessary to establish whether prehabilitation diminish the risk of developing long-term disability in high-risk patients. IMPLICATIONS FOR NURSING PRACTICE: Uro-oncology nurses are at the forefront in every ERAS program and vital in screening patients ahead of surgery for common risk factors, current impairments, and limitations that can compromise baseline functional capacity. The growing movement to standardize clinical implementation of prehabilitation, indicate there is a clear need for further investigation, optimization of a multimodal approach and an open discussion between health care providers from different areas of expertise who might best support and promote these initiatives.

Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners: Results From the Randomized ProCan Trial.

INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function. AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP. METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention. MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners. RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months. CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Optimal Delivery of Follow-Up Care After Radical Cystectomy for Bladder Cancer.

PURPOSE OF REVIEW: To identify components representing optimal delivery of follow-up care after radical cystectomy because of bladder cancer and report the current level of evidence. METHODS: We conducted a systematic literature search of the following databases: Cochrane, MEDLINE, Embase, CINAHL, Web of Science, Physiotherapy Evidence Database and ClinicalTrials.gov. The search results were managed in Covidence Reference Manager and abstracts were screened by title. Articles relevant to the subject of interest were included and the results are reported narratively. RESULTS: Several studies have evaluated the positive impact of enhanced recovery after surgery (ERAS) on length of stay, albeit not on the further impact on 90-day postoperative complication rate, functional recovery, or mortality. Minimally invasive surgery may result in a slighter shorter length of stay compared to open surgery. Physical training combined with nutritional intervention can improve functional recovery up to one year after surgery. Nutritional supplements can preserve muscle and bone mass, and potentially improve recovery. Patient education in stoma care and prevention of infection can significantly improve self-efficacy and avoid symptoms of infection postoperatively. Moreover, specific devices like applications (apps) can support these efforts. Continued smoking increases the risk of developing postoperative complications while no evidence was found on the impact of continued alcohol drinking. Currently, there is no evidence on psychological well-being, sexual health, or shared decision making interventions with an impact on rehabilitation after radical cystectomy. CONCLUSION: Data are scarce but indicate that peri- and postoperative multi-professional interventions can reduce prevalence of sarcopenia, and improve functional recovery, physical capacity, nutritional status, and self-efficacy in stoma care (level 1 evidence). Continued smoking increases the risk of complications, but the effects of a smoking and alcohol intervention remain unclear (level 3 evidence). The results of this review provide guidance for future directions in research and further attempts to develop and test an evidence-based program for follow-up care after radical cystectomy.

STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial.

BACKGROUND: To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are to examine the effect on types and grades of complications, smoking cessation and alcohol cessation, length of hospital stay, health-related quality of life and return to work or habitual level of activity up to 12 months postoperatively. METHODS/DESIGN: The study is a multi-institutional randomised clinical trial involving 110 patients with a risky alcohol intake and daily smoking who are scheduled for radical cystectomy. Patients will be randomised to the 6-week Gold Standard Programme (GSP) or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. Smoking and alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly meetings and at follow-up. DISCUSSION: Herein, we report the design of the STOP-OP study, objectives and accrual up-date. This study will provide new knowledge about how to prevent smoking and alcohol-related postoperative complications at the time of bladder cancer surgery. Till now 77 patients have been enrolled. Patient accrual is expected to be finalised before the end of 2017 and data will be published in 2018. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02188446 . Registered on 28 May 2014.

Complications and health-related quality of life after robot-assisted versus open radical cystectomy: a systematic review and meta-analysis of four RCTs.

BACKGROUND: Radical cystectomy is associated with high rates of perioperative morbidity. Robotic-assisted radical cystectomy (RARC) is widely used today despite limited evidence for clinical superiority. The aim of this review was to evaluate the effect of RARC compared to open radical cystectomy (ORC) on complications and secondary on length of stay, time back to work and health-related quality of life (HRQoL). METHODS: The databases PubMed, The Cochrane Library, Embase and CINAHL were searched. A systematic review according to the PRISMA guidelines and cumulative analysis was conducted. Randomized controlled trials (RCTs) that examined RARC compared to ORC were included in this review. We assessed the quality of evidence using the Cochrane Collaboration's 'Risk of bias' tool and Grading of Recommendations Assessment, Development and Evaluation approach. Data were extracted and analysed. RESULTS: The search retrieved 273 articles. Four RCTs were included involving overall 239 patients. The quality of the evidence was of low to moderate quality. There was no significant difference between RARC and ORC in the number of patients developing complications within 30 or 90 days postoperatively or in overall grade 3-5 complications within 30 or 90 days postoperatively. Types of complications differed between the RARC and the ORC group. Likewise, length of stay and HRQoL at 3 and 6 months did not differ. CONCLUSION: Our review presents evidence for RARC not being superior to ORC regarding complications, LOS and HRQoL. High-quality studies with consistent registration of complications and patient-related outcomes are warranted. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016038232.