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

Dragan Ilic; Sue M Evans; Christie Ann Allan; Jae Hung Jung; Declan Murphy; Mark Frydenberg

doi:10.1002/14651858.CD009625.pub2

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Figure 1

Study flow diagram

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Analysis 1.1

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 1 Urinary QoL (short term).

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Analysis 1.2

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 2 Sexual QoL (short term).

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Analysis 1.3

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 3 Surgical complications (short term).

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Analysis 1.4

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 4 Serious postoperative complications (short term).

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Analysis 1.5

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 5 Postoperative pain (at 1 day).

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Analysis 1.6

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 6 Postoperative pain (at 1 week).

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Analysis 1.7

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 7 Postoperative pain (at 12 weeks).

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Analysis 1.8

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 8 Hospital stay (short term ).

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Analysis 1.9

Comparison 1 Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy, Outcome 9 Blood transfusion (short term).

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Summary of findings for the main comparison. Laparaoscopic radical prostatectomy and robotic‐assisted laparoscopic radical prostatectomy compared to open radical prostatectomy for the treatment of localised prostate cancer

Laparaoscopic radical prostatectomy and robotic‐assisted laparoscopic radical prostatectomy compared to open radical prostatectomy for the treatment of localised prostate cancer
Participants: men with prostate cancer Setting: single surgeon or single centre Intervention: laparoscopic radical prostatectomy/robotic‐assisted laparoscopic radical prostatectomy Control: open radical prostatectomy
Outcomes	№ of participants (studies) Follow‐up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**
				Risk with ORP	Risk difference with LRP/RARP
Prostate cancer‐specific survival ‐ not reported	‐	‐	‐	‐	‐
Urinary quality of life (short‐term) Assessed with: Expanded Prostate Cancer Index Composite^a Follow‐up: mean 3 months	248 (1 RCT)	⊕⊕⊕⊝ Moderate^b	‐	The mean score was 83.8	MD 1.3 lower (4.65 lower to 2.05 higher)
Sexual quality of life (short‐term) Assessed with: Expanded Prostate Cancer Index Composite^a Follow‐up: mean 3 months	248 (1 RCT)	⊕⊕⊕⊝ Moderate^b	‐	The mean score was 35.0	MD 3.9 higher (1.84 lower to 9.64 higher)
Biochemical recurrence‐free survival ‐ not reported	‐	‐	‐	‐	‐
Overall survival ‐ not reported	‐	‐	‐	‐	‐
Overall surgical complications (short‐term) Follow‐up: mean 3 months	308 (1 RCT)	⊕⊕⊝⊝ Low^{b c}	RR 0.41 (0.16 to 1.04)	Study population
				40 per 1000	23 fewer per 1000 (33 fewer to 2 more)
				Moderate
				238 per 1000^d	140 fewer per 1000 (200 fewer to 10 more)
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LRP: Laparaoscopic radical prostatectomy; MD: mean difference; ORP: open radical prostatectomy; RCT: randomised controlled trial; RARP: robotic‐assisted laparoscopic radical prostatectomy; RR: risk ratio
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
^a Expanded Prostate Cancer Index Composite contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best). ^b Downgraded by one level for study limitation: unclear risk or high risk of one or more domains in included study or studies. ^c Downgraded by one level for imprecision: confidence interval crosses assumed threshold of clinically important difference. ^d Estimates for control event rates for surgical complications come from Gandaglia 2014.

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Table 1. Baseline characteristics

Study name	Trial period (year to year)	Country	Setting	Description of participants	Intervention(s) and comparator(s)	Duration of intervention (duration of follow‐up)	Age (yrs)	PSA (ng/mL)	Pathologic stage
Guazzoni 2006	NR	Italy	Single surgeon	Men aged < 70 years, clinically organ‐confined disease (cT1 ‐ cT2), total serum PSA < 20 ng/dL, Gleason score ≤ 7	LRP	6 days	62.29 ± 8.2	6.9 ± 2.9	T2 (75.0%), T3 (25%), surgical margin positive (26.0%)
					ORP		62.9 ± 7.4	6.5 ± 3.0	T2 (73.3%), T3 (26.6%), surgical margin positive (21.6%)
Yaxley 2016	2010 to 2014	Australia	Single centre	Men aged 35‐70 years with newly diagnosed with clinically localised prostate cancer	RARP	12 weeks	59.64 ± 6.63	7.41 ± 4.10	Extraprostatic extension (35%), seminal vesicle involvement (3%), surgical margins positive (15%)
					ORP		60.38 ± 5.81	7.57 ± 4.07	Extraprostatic extension (32%), seminal vesicle involvement (6%), surgical margins positive (10%)
LRP: laparoscopic prostatectomy; NR: not reported; ORP: open radical prostatectomy; PSA: prostate‐specific antigen; RARP: robotic‐assisted radical prostatectomy

Table 1. Baseline characteristics

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Table 2. Participants' disposition

Study name	Intervention(s) and comparator(s)	Sample size (N)	Screened/ eligible (N)	Randomised (N)	Analysed (N)	Finishing trial (N (%))
Guazzoni 2006	LRP	NR	NR	60	60	60 (100.0)
	ORP	NR	NR	60	60	60 (100.0)
	Total			120	120	120 (100.0)
Yaxley 2016	RARP	200	NR/334	163	QoL: 129 Surgical outcomes: 157^a Pain: 130	157 (96.3)
	ORP	200	NR/334	163	QoL: 119 Surgical outcomes: 151^a Pain: 120	151 (92.6)
	Total			326	QoL: 248 Surgical outcomes: 308 Pain: 250	308 (94.4)

Grand total	All interventions			223		217
	All comparators			223		211
	Overall			446		428
^aSurgical outcomes: surgical complications, hospital stay, and blood transfusions LRP: laparoscopic prostatectomy; NR: not reported; ORP: open radical prostatectomy; QoL: quality of life; RARP: robotic‐assisted radical prostatectomy

Table 2. Participants' disposition

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Comparison 1. Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Urinary QoL (short term) Show forest plot	1	248	Mean Difference (IV, Random, 95% CI)	‐1.30 [‐4.65, 2.05]

2 Sexual QoL (short term) Show forest plot	1	248	Mean Difference (IV, Random, 95% CI)	3.90 [‐1.84, 9.64]

3 Surgical complications (short term) Show forest plot	1	308	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.16, 1.04]

4 Serious postoperative complications (short term) Show forest plot	1	308	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.02, 1.32]

5 Postoperative pain (at 1 day) Show forest plot	2	423	Mean Difference (IV, Random, 95% CI)	‐1.05 [‐1.42, ‐0.68]

6 Postoperative pain (at 1 week) Show forest plot	2	416	Mean Difference (IV, Random, 95% CI)	‐0.78 [‐1.40, ‐0.17]

7 Postoperative pain (at 12 weeks) Show forest plot	1	250	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.32, 0.34]

8 Hospital stay (short term ) Show forest plot	1	308	Mean Difference (IV, Random, 95% CI)	‐1.72 [‐2.19, ‐1.25]

9 Blood transfusion (short term) Show forest plot	2	428	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.12, 0.46]

Comparison 1. Laparoscopic radical prostatectomy/ robotic‐assisted radical prostatectomy vs open radical prostatectomy

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