PMID: 23127367 [PubMed - indexed for MEDLINE] Free full text Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.Peer reviewedPublisher PD

Armstrong, N

Barocas, D A

Close, A

Eden, C G

Fraser, C

Gurung, T

Jenkinson, D

Jia, X

Lam, T B

Mowatt, G

Neal, D E

Pickard, R

Ramsay, C

Robertson, C

Robinson, M C

Royle, J

Rushton, S P

Sharma, P

Shirley, M D F

Soomro, N

Vale, L

Health Technology Assessment

English

PubMed

Background:

Complete surgical removal of the prostate, radical prostatectomy, is the most frequently used treatment option for men with localised prostate cancer. The use of laparoscopic (keyhole) and robot-assisted surgery has improved operative safety but the comparative effectiveness and cost-effectiveness of these options remains uncertain.



Objective:

This study aimed to determine the relative clinical effectiveness and cost-effectiveness of robotic radical prostatectomy compared with laparoscopic radical prostatectomy in the treatment of localised prostate cancer within the UK NHS.



Data sources:

MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, BIOSIS, Science Citation Index and Cochrane Central Register of Controlled Trials were searched from January 1995 until October 2010 for primary studies. Conference abstracts from meetings of the European, American and British Urological Associations were also searched. Costs were obtained from NHS sources and the manufacturer of the robotic system. Economic model parameters and distributions not obtained in the systematic review were derived from other literature sources and an advisory expert panel.



Review methods:

Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies of men with clinically localised prostate cancer (cT1 or cT2); outcome measures included adverse events, cancer related, functional, patient driven and descriptors of care. Two reviewers abstracted data and assessed the risk of bias of the included studies. For meta-analyses, a Bayesian indirect mixed-treatment comparison was used. Cost-effectiveness was assessed using a discrete-event simulation model.



Results:

The searches identified 2722 potentially relevant titles and abstracts, from which 914 reports were selected for full-text eligibility screening. Of these, data were included from 19,064 patients across one RCT and 57 non-randomised comparative studies, with very few studies considered at low risk of bias. The results of this study, although associated with some uncertainty, demonstrated that the outcomes were generally better for robotic than for laparoscopic surgery for major adverse events such as blood transfusion and organ injury rates and for rate of failure to remove the cancer (positive margin) (odds ratio 0.69; 95% credible interval 0.51 to 0.96; probability outcome favours robotic prostatectomy = 0.987). The predicted probability of a positive margin was 17.6% following robotic prostatectomy compared with 23.6% for laparoscopic prostatectomy. Restriction of the meta-analysis to studies at low risk of bias did not change the direction of effect but did decrease the precision of the effect size. There was no evidence of differences in cancer-related, patient-driven or dysfunction outcomes. The results of the economic evaluation suggested that when the difference in positive margins is equivalent to the estimates in the meta-analysis of all included studies, robotic radical prostatectomy was on average associated with an incremental cost per quality-adjusted life-year that is less than threshold values typically adopted by the NHS (£30,000) and becomes further reduced when the surgical capacity is high.



Limitations:

The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction.



Conclusions:

This study demonstrated that robotic prostatectomy had lower perioperative morbidity and a reduced risk of a positive surgical margin compared with laparoscopic prostatectomy although there was considerable uncertainty. Robotic prostatectomy will always be more costly to the NHS because of the fixed capital and maintenance charges for the robotic system. Our modelling showed that this excess cost can be reduced if capital costs of equipment are minimised and by maintaining a high case volume for each robotic system of at least 100-150 procedures per year. This finding was primarily driven by a difference in positive margin rate. There is a need for further research to establish how positive margin rates impact on long-term outcomes.



Funding:

The National Institute for Health Research Health Technology Assessment programm

Ramsay, C. R. (Craig R.)

Pickard, R.

Robertson, C.

Close, A.

Vale, L. (Luke)

Armstrong, N.

Barocas, D. A.

Eden, C. G.

Fraser, C.

Gurung, T. (Tara)

Jenkinson, D.

Jia, X.

Lam, T. B.

Mowatt, G.

Neal, D. E.

Robinson, M. C.

Royle, J.

Rushton, S. P.

Sharma, P.

Shirley, M. D. F.

Soomro, N.

Warwick Research Archives Portal Repository

Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer

C Ramsay

R Pickard

C Robertson

A Close

L Vale

N Armstrong

DA Barocas

CG Eden

C Fraser

T Gurung

D Jenkinson

X Jia

TB Lam

G Mowatt

DE Neal

MC Robinson

J Royle

SP Rushton

P Sharma

MDF Shirley

N Soomro

Directory of Open Access Journals

Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer.

Research Archive

[Anesthesia management for laparoscopic prostatectomy and open prostatectomy.]

[Comparative study of surgical efficacy in open versus laparoscopic prostatectomy: virtual prostate reconstruction and periprostatic tissue quantification.] Actas Urolog Espanol

[Comparison between open and laparoscopic approach in radical prostatectomy.] Actas Urol Esp 2007;31:141–5. Remzi

[Radical prostatectomy for men aged <56 years with prostate cancer. Cost of illness analysis]. Urologe (Ausg 1185;A);44:1183–4.

[Radical prostatectomy: evaluation of learning curve outcomes laparoscopic and robotic-assisted laparoscopic techniques with radical retropubic prostatectomy.] Actas Urolog Espanol

[Study of urinary continence after radical prostatectomy. Comparison between laparoscopic and retropubic prostatectomy based on a series of 251 cases.] Prog Urol

29 TS=trade off #30 TS= conjoint analys* #31 #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or

9000 S t r a t e g y c o s t (

A comparative histopathologic study of prostate cancer treated by conventional radical prostatectomy and robotic-assisted laparoscopic radical prostatectomy: a series of 1006 cases.

A comparison of post operative inguinal hernia rates after laparoscopic, retropubic and perineal radical prostatectomy.

A comparison of robotic assisted versus extraperitoneal laparoscopic radical prostatectomy: a single surgeon experience.

A comparison of robotic assisted versus pure laparoscopic radical prostatectomy: a single surgeon experience.

A comparison of the peri-operative data after open radical retropubic prostatectomy or robotic-assisted laparoscopic prostatectomy.

A cost comparison of laparoscopic versus open radical cystoprostatectomy and orthotopic ileal neobladder at a single institution. Arch Ital Urol Androl

A cost-analysis comparison of laparoscopic radical prostatectomy versus open radical prostatectomy: the McMaster Institute of Urology experience. Can Urol Assoc J 2010;4:237–41. Anastasiadis

A cost-outcome analysis of long-term adjuvant goserelin in addition to radiotherapy for locally advanced prostate cancer. Semin Urol Oncol 2003;21:171–7. Not cost-effectiveness analysis (form of cost comparison only) (n = 9) 1. Al-Shaiji

A critique and impact analysis of decision modeling assumptions. Med Decis Making

A direct comparison of robotic assisted versus pure laparoscopic radical prostatectomy: a single institution experience. J Urol 2007;178:478–82. Salomon

A prospective, nonrandomized trial comparing robot-assisted laparoscopic and retropubic radical prostatectomy in one European institution. BJU Int 2009;104:534–9. Fornara

A retrospective comparison of anesthetic management of robot-assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

A selected review and personal experience with robotic prostatectomy: implications for adoption of this new technology in the United Kingdom. Prostate Cancer Prostat Dis

Anatomical retrograde laparoscopic prostatectomy improves postoperative erections without increasing of surgical margins: a comparative study. Eur Urol Suppl

Annual Scientific Meeting,

Assessment of patient preferences among men with prostate cancer.

Assoc Thai

Barton-Watson, Public contributor Professor Nadine Foster, Professor of Musculoskeletal Health in Primary Care Arthritis Research,

Bayesian approaches to multiple sources of evidence and uncertainty in complex cost-effectiveness modelling. Stat Med

Bayesian methods in meta-analysis and evidence synthesis.

Cancer incidence and mortality in the United Kingdom and constituent countries, 2003–05. Health Statistics Quarterly 40. [document on the Internet]. London: Office for National Statistics;

Cancer statistics registration. Registration of cancer diagnosis in 2006, England. [document on the Internet]. London: Office for National Statistics;

Centre for Reviews and Dissemination URL: http://nhscrd.york.ac.uk/welcome.htm #1 MeSH prostatic neoplasms

Characteristics of positive surgical margins in robotic assisted laparoscopic radical prostatectomy (RobRP), open retropubic radical prostatectomy (RRP) and laparoscopic radical prostatectomy (LapRP): a comparative study from a single academic center.

Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg

Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [document on the Internet]. The Cochrane Collaboration;

Comparative analysis of the impact of prostate volume on positive surgical margin incidence and location between open and laparoscopic radical prostatectomy.

Comparative analysis of the impact of prostate volume on positive surgical margin incidence and location between open and laparoscopic radical prostatectomy. Eur Urol Suppl

Comparative study between radical retropubic prostatectomy and laparoscopic prostatectomy in our initial series (1988–1997 and 2005–2006).

Comparison of functional outcomes between robot-assisted radical prostatectomy and radical retropubic prostatectomy: a single surgeon experience.

Comparison of length of hospital stay between radical retropubic prostatectomy and robotic assisted laparoscopic prostatectomy.

Comparison of open and laparoscopic radical prostatectomy outcomes from a surgeon’s early experience. Urology 2007;70:667–71. White

Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer.

Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in

Contemporary laparoscopic and open radical retropubic prostatectomy: pathologic outcomes and Kattan postoperative nomograms are equivalent.

Cost analysis of radical retropubic, perineal, and robotic prostatectomy.

Cost benefit of emerging technology in localized carcinoma of the prostate.

Cost comparison of curative therapies for localized prostate cancer in Japan: a single-institution experience.

Cost comparison of laparoscopic versus radical retropubic prostatectomy. Urology

Cost comparison of robotic, laparoscopic and open radical prostatectomy. Eur Urol Suppl 2009;8:364. Brown

Cost comparison of robotic, laparoscopic, and open radical prostatectomy for prostate cancer. Eur Urol 2010;57:453–8.

Cost-effectiveness acceptability curve for each intervention in the base case, 10-year time horizon (50 procedures).282

Cost-effectiveness of clopidogrel: seeing through the smoke. Med Decis Making

Cost-effectiveness study of robot-assisted laparoscopic versus open retropubic radical prostatectomy. Eur Urol Suppl 2010;9:505.

Defining biochemical recurrence of prostate cancer after radical prostatectomy: a proposal for a standardized definition.

Details of illustrative costs of upgrading a robotic system Surgical system upgrade List price (£) 4 years, arrears (£) 5 years, advance (£) 5 years, arrears (£) 6 years, advance (£) 6 years, arrears (£) 7 years, advance (£) da Vinci S HD to da Vinci Si HD

Direct comparison of surgical and functional outcomes of robotic-assisted versus pure laparoscopic radical prostatectomy: single-surgeon experience.

Do older men benefit from curative therapy of localized prostate cancer?

DOI: 10.3310/hta16410 6. Risk of bias from selective reporting (assess for each outcome; note: different to existing Chapter 8 recommendation)

DOI: 10.3310/hta16410 9500 9000 S t r a t e g y c o s t (

DOI: 10.3310/hta16410 Appendix 13 Costs of laparoscopic equipment TABLE 77 Cost of laparoscopic system Surgical equipment Number of units Unit cost (capital) (£) Operative service life (years) Numbers of procedures Cost per procedure (£)

DOI: 10.3310/hta16410 Appendix 15 Density charts describing the distribution of total costs and quality-adjusted life-years for the cohort of modelled men for each analysis presented278

DOI: 10.3310/hta16410 Appendix 6 List of excluded studies: comparative studies in which number of patients for each baseline clinical stage was unclear 1. Abe

DOI: 10.3310/hta16410 Diagnostic Technologies and Screening Panel Members Chair, Professor Lindsay Wilson Turnbull, Scientific Director of the Centre for Magnetic Resonance Investigations and YCR Professor of Radiology,

DOI: 10.3310/hta16410 health technology assessment programme

DOI: 10.3310/hta16410 Pharmaceuticals Panel Members Chair, Professor Imti Choonara, Professor in Child Health,

DOI: 10.3310/hta16410 Study Measures Timing Robotic Laparoscopic Open Notes, e.g. validated measure or not Mental health, mean (SD)

DOI: 10.3310/hta16410 Study Measures Timing Robotic, n/N (%)a Laparoscopic, n/N (%)a Open, n/N (%)a Notes Urinary bother (UCLAPCI), mean (SD)

DOI: 10.3310/hta16410 Study Outcome reported as Robotic, n/N (%)a Laparoscopic, n/N (%)a Open, n/N (%)a Notes Krambeck 2008108

DOI: 10.3310/hta16410 Study Subgroup Timing Robotic, n/N (%)a Laparoscopic, n/N (%)a Open, n/N (%)a Notes Pathological Gleason score Anastasiadis 2003122 6.7, 1.1 (4–10) 6.9, 0.9 (5–10) Mean,

DOI: 10.3310/hta16410 Study Subgroup Timing Robotic, n/N (%)a Laparoscopic, n/N (%)a Open, n/N (%)a Notes Risk of positive surgical margins,

DOI: 10.3310/hta16410 TABLE 55 Summary of outcomes: efficacy Study Subgroup Timing Robotic, n/N (%)a Laparoscopic, n/N (%)a Open, n/N (%)a Notes Positive margin Anastasiadis

DOI: 10.3310/hta16410 TABLE 57 Summary of outcomes: quality of life Study Measures Timing Robotic Laparoscopic Open Notes, e.g. validated measure or not Guazzoni

Early and delayed return of urinary continence after radical prostatectomy: results of a prospective comparative trial of an open retropubic vs. robotic approach.

Early experience of robotic assisted laparoscopic radical prostatectomy.

Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10).

Economic evaluation of different hormonal therapies for prostate cancer: final results from the Quality of Life Antiandrogen Blockade Italian Observational Study (QuABIOS). Arch Ital Urol Androl 2007;79:104–7.268

Effect of a large prostate gland on open and robotically assisted laparoscopic radical prostatectomy.

Effectiveness and cost-effectiveness of prognostic markers in prostate cancer.

Endoscopic radical prostatectomy – da Vinci (TM) vs. laparoscopy in a single centre experience.

Establishing a robotic prostatectomy programme: The impact of mentoring using a structured approach.

Eur Urol 2007;52:1090–6. Trabulsi

Evidence based pathway for perioperative management of open and robotic assisted laparoscopic radical prostatectomy.

Financial comparative analysis of minimally invasive surgery to open surgery for localized prostate cancer: a single-institution experience. Urology

From conventional laparoscopic prostatectomy to da Vinci prostatectomy.

Functional and histological comparative results of laparoscopic radical prostatectomy and robotic-assisted laparoscopic radical prostatectomy: prospective study by one surgeon. Eur Urol Suppl

Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party.

Handling uncertainty in cost-effectiveness models.

Handling uncertainty in economic evaluations and presenting the results.

Head-to-head comparison of retropubic, perineal and laparoscopic radical prostatectomy.

Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. Stat Med

High radical prostatectomy surgical volume is related to lower radical prostatectomy total hospital charges. Eur Urol

Individualized predictions of disease progression following radiation therapy for prostate cancer.

Intrafascial bilateral nerve-sparing radical prostatectomy: a comparative functional analysis between open and robotic-assisted video-laparoscopic approaches.

Intraoperative blood loss and transfusion requirements for robotic-assisted radical prostatectomy versus radical retropubic prostatectomy.

Intraoperative management of robotic-assisted versus open radical prostatectomy.

Is combined androgen blockade with bicalutamide cost-effective compared with combined androgen blockade with flutamide. Urology

Is robot assistance affecting operating room time compared with pure retroperitoneal laparoscopic radical prostatectomy?

laparoscopic and robot-assisted total prostatectomies: comparison of postoperative course and histological and functional results based on a series of 86 prostatectomies.] Prog Urol

Laparoscopic and robotic assisted radical prostatectomy – critical analysis of the results.

Laparoscopic prostatectomy: extraperitoneal: all B. Open prostatectomy Nerve sparing: A: unilateral = 3/30; bilateral = 7/30; non-nerve sparing =

Laparoscopic prostatectomy: group 1: ≥ 71 years; group 2: ≤ 59 years Nerve sparing: Unilateral: group 1: 13 (18%); group 2: 41 (31%) Bilateral: group 1: 2 (2.8%); group 2: 30 (22.7%) B. Open prostatectomy: historical cohort from

Crossref

https://aura.abdn.ac.uk/bitstream/2164/2665/1/Ramsay_2012.pdf

Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer

Abstract

Similar works

Full text

Available Versions

Warwick Research Archives Portal Repository

Directory of Open Access Journals

Research Archive

Crossref