Robot‐assisted surgery in gynaecology

Hongqian Liu; Theresa A Lawrie; DongHao Lu; Huan Song; Lei Wang; Gang Shi

doi:10.1002/14651858.CD011422

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Figure 1

Study flow diagram for updated searches (30 June 2014).

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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

Intraoperative and postoperative complications, with Martinez‐Maestro 2014 included.

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Figure 4

Total operating time, with Martinez‐Maestro 2014 included.

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Analysis 1.1

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 1 Intraoperative and postoperative complications.

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Analysis 1.2

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 2 Intraoperative complications.

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Analysis 1.3

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 3 Sensitivity analysis: intraoperative complications.

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Analysis 1.4

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 4 Complications: intraoperative injury.

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Analysis 1.5

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 5 Postoperative complications.

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Analysis 1.6

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 6 Sensitivity analysis: postoperative complications.

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Analysis 1.7

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 7 Complications: bleeding.

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Analysis 1.8

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 8 Complications: infection.

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Analysis 1.9

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 9 Total operating time.

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Analysis 1.10

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 10 Operating room time [min].

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Analysis 1.11

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 11 Overall hospital stay.

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Analysis 1.12

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 12 Conversion to another approach.

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Analysis 1.13

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 13 Blood transfusions.

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Analysis 1.14

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 14 Estimated blood loss.

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Analysis 1.15

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 15 Pain at 1 to 2 weeks.

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Analysis 1.16

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 16 Quality of life (6 weeks).

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Analysis 1.17

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 17 Quality of life (6 months).

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Analysis 1.18

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 18 Reintervention.

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Analysis 1.19

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 19 Readmission.

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Analysis 1.20

Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery, Outcome 20 Overall cost.

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Robot‐assisted surgery (RAS) compared with conventional laparoscopic surgery (CLS) for gynaecological disease
Patient or population: women with benign gynaecological disease requiring surgery Settings: hospital Intervention: RAS Comparison: CLS
Outcomes	Illustrative comparative risks^a (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	CLS	RAS
Intraoperative and postoperative complications	All procedures (subgroups were similar)		RR 0.95 (0.46 to 1.99)	513 (6)	⊕⊕⊝⊝ Low	Downgraded because of inconsistency (I² = 74%) and imprecision. Early studies favoured CLS, whereas later studies favoured RAS but had other limitations
	19 per 100	18 per 100 (9 to 38)
Intraoperative complications only	All procedures (subgroups were similar)		RR 1.71 (0.83 to 3.52)	337 (4)	⊕⊕⊝⊝ Low	Downgraded because of imprecision and study limitations (2 early studies contributed 16/17 adverse events in the RAS arm). Sensitivity analyses suggest that effect estimate is likely to change
	6 per 100	10 per 100 (5 to 21)
Postoperative complications only	Hysterectomy		RR 0.62 (0.30 to 1.29) RR 3.54 (1.31 to 9.56)	315 (3) 68 (1)	⊕⊕⊝⊝ Low ⊕⊝⊝⊝ Very low	Downgraded because of imprecision and study limitations. Early studies tend to favour CLS, whereas later studies favour RAS but had other limitations Only 1 small, early study reported data, which included urinary tract infections
	16 per 100	10 per 100 (5 to 21)
	Sacrocolpopexy
	12 per 100	42 per 100 (16 to 100)
Intraoperative injury	All procedures (subgroups were similar)		RR 1.23 (0.44 to 3.46)	415 (5)	⊕⊕⊕⊝ Moderate	Downgraded because of imprecision
	3 per 100	4 per 100 (1 to 10)
Total operating time (minutes)	Mean total operating time ranged across control groups from 75 to 178 minutes	Mean total operating time in the intervention groups ranged from 96 to 265 minutes (21 to 87 minutes longer)	MD 41.71 (17.08 to 66.33)	294 (4)	⊕⊕⊕⊝ Moderate	Downgraded because of inconsistency (I² = 82%). 2 studies that could not be included in the meta‐analysis reported no significant differences in median operating times
Overall hospital stay (days)	Hysterectomy		MD ‐0.30 (‐0.54 to ‐0.06)	217 (2)	⊕⊕⊝⊝ Low	Downgraded because of risk of bias concerns and imprecision (effect estimate ranged from 1 to 13 hours shorter hospital stay in RAS group)
	Mean hospital stay ranged across control groups from 1.4 to 3.6 days	Mean hospital stay in the intervention groups was 1.1 to 3.3 days (0.3 days lower)
	Sacrocolpopexy		MD 0.37 (‐0.16 to 0.90)	68 (1)	⊕⊕⊝⊝ Low	Downgraded because of study limitations and sparse data
	Mean hospital stay in the control group was 1.42 days	Mean hospital stay in the intervention group was 1.79 days
Conversion to another approach	All procedures (subgroups were similar)		RR 1.29 (0.40 to 4.16)	338 (4)	⊕⊕⊕⊝ Moderate	Downgraded because of imprecision
	3 per 100	4 per 100 (1 to 12)
^aThe basis for the assumed risk for dichotomous data is the mean control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; CLS: Conventional laparoscopic surgery; MD: Mean difference; RR: Risk ratio; RAS: Robot‐assisted surgery.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

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Table 1. Summary of ongoing trials

Study ID	Malignant (M)/Benign (B) disease	Participants (N)	Number enrolled by June 2014^a	Comparison	Procedure	Main outcomes	Primary completion date^a
Harkins 2013^b NCT01581905	B: menorrhagia, dysfunctional uterine bleeding, fibroids, endometriosis	400 (closed at 113)	Completed	RAS versus CLS	Hysterectomy	Operating time, EBL, complications, LOS	March 2013
LAROSE 2012 NCT01556204	B: endometriosis	74	‐	RAS versus CLS	Surgery for endometriosis	Operating time, pain	December 2013
Narducci 2010 NCT01247779	M: cervical, uterine and ovarian cancers	374	320	RAS versus CLS	Surgical staging procedures	Complications, lymph node yield, surgeons' ergonomy, QoL	June 2015
Kjolhede 2012 NCT01526655	M: endometrial cancer	50	30	RAS versus open surgery	Hysterectomy, BSO and lavage	QoL, biomarkers, adverse events	December 2015
RASHEC 2013 NCT01847703	M: endometrial cancer	100	45	RAS versus open surgery	Hysterectomy, BSO and LA	Lymph node yield, complications	April 2016
Obermair 2008 NCT00614211	M: cervical cancer	740	340	RAS or CLS versus open surgery	Radical hysterectomy	DFS, complications, QoL, OS	July 2018
For further details, see Characteristics of ongoing studies. ^aUpdated according to contact investigator correspondence when possible. ^bSame as Green 2013. This study has been completed but not yet reported in full. Data on 98 women were presented in 2013 and have been included in this review. Abbreviations: CLS = conventional laparoscopic surgery; DFS = disease‐free survival; EBL = estimated blood loss; LOS = length of stay; OS = overall survival; QoL = quality of life; RAS = robot‐assisted surgery.

Table 1. Summary of ongoing trials

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Comparison 1. Robot‐assisted surgery versus conventional laparoscopic surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intraoperative and postoperative complications Show forest plot	6	513	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.46, 1.99]

1.1 Hysterectomy	4	367	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.31, 1.88]
1.2 Sacrocolpopexy	2	146	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.26, 6.72]
2 Intraoperative complications Show forest plot	4	337	Risk Ratio (M‐H, Random, 95% CI)	1.71 [0.83, 3.52]

2.1 Hysterectomy	3	269	Risk Ratio (M‐H, Random, 95% CI)	1.67 [0.75, 3.73]
2.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.89 [0.37, 9.62]
3 Sensitivity analysis: intraoperative complications Show forest plot	3	215	Risk Ratio (M‐H, Random, 95% CI)	1.78 [0.84, 3.75]

3.1 Hysterectomy	2	147	Risk Ratio (M‐H, Random, 95% CI)	1.75 [0.76, 4.06]
3.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.89 [0.37, 9.62]
4 Complications: intraoperative injury Show forest plot	5	415	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.44, 3.46]

4.1 Hysterectomy	3	269	Risk Ratio (M‐H, Random, 95% CI)	1.62 [0.20, 12.91]
4.2 Sacrocolpopexy	2	146	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.34, 3.70]
5 Postoperative complications Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Hysterectomy	3	315	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.30, 1.29]
5.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	3.54 [1.31, 9.56]
6 Sensitivity analysis: postoperative complications Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 Hysterectomy	2	217	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.18, 2.28]
6.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	3.54 [1.31, 9.56]
7 Complications: bleeding Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Hysterectomy	4	367	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.10, 1.66]
8 Complications: infection Show forest plot	5	435	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.42, 3.36]

8.1 Hysterectomy	4	367	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.13, 2.88]
8.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.89 [0.63, 5.68]
9 Total operating time Show forest plot	4	294	Mean Difference (IV, Random, 95% CI)	41.71 [17.08, 66.33]

9.1 Hysterectomy	2	148	Mean Difference (IV, Random, 95% CI)	41.18 [‐6.17, 88.53]
9.2 Sacrocolpopexy	2	146	Mean Difference (IV, Random, 95% CI)	44.99 [4.23, 85.76]
10 Operating room time [min] Show forest plot	4	294	Mean Difference (IV, Random, 95% CI)	42.51 [20.96, 64.06]

10.1 Hysterectomy	2	148	Mean Difference (IV, Random, 95% CI)	44.35 [5.22, 83.47]
10.2 Sacrocolpopexy	2	146	Mean Difference (IV, Random, 95% CI)	43.24 [0.12, 86.35]
11 Overall hospital stay Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

11.1 Hysterectomy	2	217	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐0.54, ‐0.06]
11.2 Sacrocolpopexy	1	68	Mean Difference (IV, Random, 95% CI)	0.37 [‐0.16, 0.90]
12 Conversion to another approach Show forest plot	4	337	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.40, 4.12]

12.1 Hysterectomy	3	269	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.24, 5.77]
12.2 Sacrocolpopexy	1	68	Risk Ratio (M‐H, Random, 95% CI)	1.41 [0.25, 7.94]
13 Blood transfusions Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 Hysterectomy	3	272	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.24, 6.21]
14 Estimated blood loss Show forest plot	2	173	Mean Difference (IV, Random, 95% CI)	3.54 [‐20.12, 27.21]

14.1 Hysterectomy	1	95	Mean Difference (IV, Random, 95% CI)	7.0 [‐18.26, 32.26]
14.2 Sacrocolpopexy	1	78	Mean Difference (IV, Random, 95% CI)	‐21.30 [‐89.02, 46.42]
15 Pain at 1 to 2 weeks Show forest plot	2	114	Std. Mean Difference (IV, Random, 95% CI)	0.22 [‐0.26, 0.70]

15.1 Hysterectomy	1	36	Std. Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.74, 0.56]
15.2 Sacrocolpopexy	1	78	Std. Mean Difference (IV, Random, 95% CI)	0.41 [‐0.03, 0.86]
16 Quality of life (6 weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

16.1 Sacrocolpopexy	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
17 Quality of life (6 months) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

17.1 Hysterectomy	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
18 Reintervention Show forest plot	3	295	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.08, 1.54]

18.1 Hysterectomy	1	122	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.03, 2.17]
18.2 Sacrocolpopexy	2	173	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.06, 3.59]
19 Readmission Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

19.1 Hysterectomy	2	220	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.14, 1.48]
20 Overall cost Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Totals not selected

20.1 Hysterectomy	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
20.2 Sacrocolpopexy	2		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Robot‐assisted surgery versus conventional laparoscopic surgery

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