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Laparoscopic and robotic‐assisted versus open radical prostatectomy for the treatment of localised prostate cancer

Background

Prostate cancer is commonly diagnosed in men worldwide. Surgery, in the form of radical prostatectomy, is one of the main forms of treatment for men with localised prostate cancer. Prostatectomy has traditionally been performed as open surgery, typically via a retropubic approach. The advent of laparoscopic approaches, including robotic‐assisted, provides a minimally invasive alternative to open radical prostatectomy (ORP).

Objectives

To assess the effects of laparoscopic radical prostatectomy or robotic‐assisted radical prostatectomy compared to open radical prostatectomy in men with localised prostate cancer.

Search methods

We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings with no restrictions on the language of publication or publication status, up until 9 June 2017. We also searched bibliographies of included studies and conference proceedings.

Selection criteria

We included all randomised controlled trials (RCTs) with a direct comparison of laparoscopic radical prostatectomy (LRP) and robotic‐assisted radical prostatectomy (RARP) to ORP, including pseudo‐RCTs.

Data collection and analysis

Two review authors independently classified studies and abstracted data. The primary outcomes were prostate cancer‐specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence‐free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions. We performed statistical analyses using a random‐effects model and assessed the quality of the evidence according to GRADE.

Main results

We included two unique studies with 446 randomised participants with clinically localised prostate cancer. The mean age, prostate volume, and prostate‐specific antigen (PSA) of the participants were 61.3 years, 49.78 mL, and 7.09 ng/mL, respectively.

Primary outcomes
We found no study that addressed the outcome of prostate cancer‐specific survival. Based on data from one trial, RARP likely results in little to no difference in urinary quality of life (MD ‐1.30, 95% CI ‐4.65 to 2.05) and sexual quality of life (MD 3.90, 95% CI ‐1.84 to 9.64). We rated the quality of evidence as moderate for both quality of life outcomes, downgrading for study limitations.

Secondary outcomes
We found no study that addressed the outcomes of biochemical recurrence‐free survival or overall survival.

Based on one trial, RARP may result in little to no difference in overall surgical complications (RR 0.41, 95% CI 0.16 to 1.04) or serious postoperative complications (RR 0.16, 95% CI 0.02 to 1.32). We rated the quality of evidence as low for both surgical complications, downgrading for study limitations and imprecision.

Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at one day (MD ‐1.05, 95% CI ‐1.42 to ‐0.68 ) and up to one week (MD ‐0.78, 95% CI ‐1.40 to ‐0.17). We rated the quality of evidence for both time‐points as low, downgrading for study limitations and imprecision. Based on one study, RARP likely results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI ‐0.32 to 0.34). We rated the quality of evidence as moderate, downgrading for study limitations.

Based on one study, RARP likely reduces the length of hospital stay (MD ‐1.72, 95% CI ‐2.19 to ‐1.25). We rated the quality of evidence as moderate, downgrading for study limitations.

Based on two study, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI 0.12 to 0.46). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1000 men (95% CI 78 fewer to 48 fewer). We rated the quality of evidence as low, downgrading for study limitations and indirectness.

We were unable to perform any of the prespecified secondary analyses based on the available evidence. All available outcome data were short‐term and we were unable to account for surgeon volume or experience.

Authors' conclusions

There is no high‐quality evidence to inform the comparative effectiveness of LRP or RARP compared to ORP for oncological outcomes. Urinary and sexual quality of life‐related outcomes appear similar.

Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions. All available outcome data were short‐term, and this study was unable to account for surgeon volume or experience.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Laparoscopic and robotic‐assisted versus open radical prostatectomy for the treatment of localised prostate cancer

Review question
How does laparoscopic and robot‐assisted laparoscopic surgery compare in the treatment of men with prostate cancer?

Background
Prostate cancer is a common cancer in men, often treated by surgical removal. Traditionally, surgeons used to make an incision on the lower abdomen to take the prostate. This procedure is called open radical prostatectomy (ORP). More recently, surgeons have started to use other ways to perform the same operation. Laparoscopic radical prostatectomy (LRP) allows surgeons to work inside the patient with long instruments and a tiny camera through small incisions. Laparoscopic surgery can be done with the use of a robotic device, which allows the surgeon to have a magnified, three‐dimensional view and operate from a console, away from the patient. This procedure is called robotic‐assisted radical prostatectomy (RARP). It is unclear whether the newer LRP and RARP approaches are better for patients.

Study characteristics
This review identified two randomised controlled trials of 446 men with prostate cancer, with an average age of approximately 60 years, that compared LRP or RARP to ORP.

Key results
We found no evidence as to how LRP or RARP compared to ORP in terms of reducing the risk of dying from prostate cancer, preventing the cancer from coming back or dying of any cause. Mens' quality of life was likely similar related to their urinary and sexual function. There appears to be no differences in postoperative surgical complications. LRP or RARP may have a small possibly unimportant effect on postoperative pain at one day and up to one week. However, no difference between RARP and ORP was found at 12 weeks postoperatively. Men having LRP or RARP likely have a shorter hospital stay and may need fewer blood transfusions.

Quality of evidence
We found no trial evidence for any cancer outcome. The evidence for quality of life were moderate; that for overall and serious surgical complications were low quality. Postoperative pain were low (up to one week) and moderate (at 12 weeks) quality of evidence. The quality of evidence for hospital stay and blood transfusions were moderate and low, respectively. Collectively, the most outcomes were low to moderate quality of evidence. This means that our estimates are likely to be close to the truth but that there is a possibility that they may be different.