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. 2019 Apr 15;4(4):CD011422.
doi: 10.1002/14651858.CD011422.pub2.

Robot-assisted surgery in gynaecology

Affiliations

Robot-assisted surgery in gynaecology

Theresa A Lawrie et al. Cochrane Database Syst Rev. .

Abstract

Background: This is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.

Objectives: To assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.

Search methods: For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, and EMBASE via Ovid, on 8 January 2018. We searched www.ClinicalTrials.gov. on 16 January 2018.

Selection criteria: Randomised controlled trials (RCTs) comparing RAS versus CLS or open surgery in women requiring surgery for gynaecological disease.

Data collection and analysis: Two review authors independently assessed studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We examined different procedures in separate comparisons and for hysterectomy subgrouped data according to type of disease (non-malignant versus malignant). When more than one study contributed data, we pooled data using random-effects methods in RevMan 5.3.

Main results: We included 12 RCTs involving 1016 women. Studies were at moderate to high overall risk of bias, and we downgraded evidence mainly due to concerns about risk of bias in the studies contributing data and imprecision of effect estimates. Procedures performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. Among studies of women undergoing hysterectomy procedures, two studies involved malignant disease (endometrial cancer); the rest involved non-malignant disease.• RAS versus CLS (hysterectomy)Low-certainty evidence suggests there might be little or no difference in any complication rates between RAS and CLS (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.54 to 1.59; participants = 585; studies = 6; I² = 51%), intraoperative complication rates (RR 0.77, 95% CI 0.24 to 2.50; participants = 583; studies = 6; I² = 37%), postoperative complications (RR 0.81, 95% CI 0.48 to 1.34; participants = 629; studies = 6; I² = 44%), and blood transfusions (RR 1.94, 95% CI 0.63 to 5.94; participants = 442; studies = 5; I² = 0%). There was no statistical difference between malignant and non-malignant disease subgroups with regard to complication rates. Only one study reported death within 30 days and no deaths occurred (very low-certainty evidence). Researchers reported no survival outcomes.Mean total operating time was longer on average in the RAS arm than in the CLS arm (mean difference (MD) 41.18 minutes, 95% CI -6.17 to 88.53; participants = 148; studies = 2; I² = 80%; very low-certainty evidence), and the mean length of hospital stay was slightly shorter with RAS than with CLS (MD -0.30 days, 95% CI -0.53 to -0.07; participants = 192; studies = 2; I² = 0%; very low-certainty evidence).• RAS versus CLS (sacrocolpopexy)Very low-certainty evidence suggests little or no difference in rates of any complications between women undergoing sacrocolpopexy by RAS or CLS (RR 0.95, 95% CI 0.21 to 4.24; participants = 186; studies = 3; I² = 78%), nor in intraoperative complications (RR 0.82, 95% CI 0.09 to 7.59; participants = 108; studies = 2; I² = 47%). Low-certainty evidence on postoperative complications suggests these might be higher with RAS (RR 3.54, 95% CI 1.31 to 9.56; studies = 1; participants = 68). Researchers did not report blood transfusions and deaths up to 30 days.Low-certainty evidence suggests that RAS might be associated with increased operating time (MD 40.53 min, 95% CI 12.06 to 68.99; participants = 186; studies = 3; I² = 73%). Very low-certainty evidence suggests little or no difference between the two techniques in terms of duration of stay (MD 0.26 days, 95% CI -0.15 to 0.67; participants = 108; studies = 2; I² = 0%).• RAS versus open abdominal surgery (hysterectomy)A single study with a total sample size of 20 women was included in this comparison. For most outcomes, the sample size was insufficient to show any possible differences between groups.• RAS versus CLS for endometriosisA single study with data for 73 women was included in this comparison; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition. For most outcomes, event rates were low, and the sample size was insufficient to detect potential differences between groups.

Authors' conclusions: Evidence on the effectiveness and safety of RAS compared with CLS for non-malignant disease (hysterectomy and sacrocolpopexy) is of low certainty but suggests that surgical complication rates might be comparable. Evidence on the effectiveness and safety of RAS compared with CLS or open surgery for malignant disease is more uncertain because survival data are lacking. RAS is an operator-dependent expensive technology; therefore evaluating the safety of this technology independently will present challenges.

PubMed Disclaimer

Conflict of interest statement

Hongqian Liu: none known. Theresa A. Lawrie: none known. DongHao Lu: none known. Therese Dowswell: none known. Huan Song: none known. Lei Wang: none known. Gang Shi: none known.

Figures

1
1
Study flow diagram for updated searches (30 June 2014).
2
2
Study flow diagram for updated search (8 January 2018).
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 1 Intraoperative and postoperative complications.
1.2
1.2. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 2 Intraoperative complications.
1.3
1.3. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 3 Complications: intraoperative injury.
1.4
1.4. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 4 Postoperative complications.
1.5
1.5. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 5 Complications: bleeding.
1.6
1.6. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 6 Complications: infection.
1.7
1.7. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 7 Total operating time.
1.8
1.8. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 8 Operating room time [min].
1.9
1.9. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 9 Overall hospital stay.
1.10
1.10. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 10 Conversion to another approach.
1.11
1.11. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 11 Blood transfusions.
1.12
1.12. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 12 Estimated blood loss.
1.13
1.13. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 13 Pain at 1 to 2 weeks.
1.14
1.14. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 14 Quality of life (6 weeks).
1.15
1.15. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 15 Quality of life (6 months).
1.16
1.16. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 16 Re‐intervention.
1.17
1.17. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 17 Re‐admission.
1.18
1.18. Analysis
Comparison 1 Robot‐assisted surgery versus conventional laparoscopic surgery (hysterectomy), Outcome 18 Overall cost.
2.1
2.1. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 1 Intraoperative and postoperative complications.
2.2
2.2. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 2 Intraoperative complications.
2.3
2.3. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 3 Complications: intraoperative injury.
2.4
2.4. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 4 Postoperative complications.
2.6
2.6. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 6 Complications: infection.
2.7
2.7. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 7 Total operating time.
2.8
2.8. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 8 Operating room time [min].
2.9
2.9. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 9 Overall hospital stay.
2.10
2.10. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 10 Conversion to another approach.
2.12
2.12. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 12 Estimated blood loss.
2.13
2.13. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 13 Pain at 1 to 2 weeks.
2.14
2.14. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 14 Quality of life (6 weeks).
2.16
2.16. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 16 Re‐intervention.
2.18
2.18. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 18 Overall cost.
2.19
2.19. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 19 Complications: urinary incontinence.
2.20
2.20. Analysis
Comparison 2 Robot‐assisted surgery versus conventional laparoscopic surgery (sacrocolpopexy)), Outcome 20 Complications: sexual dysfunction.
3.1
3.1. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 1 Intraoperative and postoperative complications.
3.2
3.2. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 2 Intraoperative complications.
3.3
3.3. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 3 Postoperative complications.
3.4
3.4. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 4 Death within 30 days.
3.5
3.5. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 5 Complications: bleeding.
3.6
3.6. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 6 Complications: infection.
3.7
3.7. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 7 Blood transfusions.
3.8
3.8. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 8 Quality of life (4 weeks).
3.9
3.9. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 9 Re‐admission.
3.10
3.10. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 10 Overall cost.
3.11
3.11. Analysis
Comparison 3 Robot‐assisted laparoscopic surgery versus open abdominal surgery (hysterectomy), Outcome 11 Lymph node yield.
4.1
4.1. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 1 Intraoperative complications.
4.2
4.2. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 2 Postoperative complications.
4.3
4.3. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 3 Complications: infection.
4.4
4.4. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 4 Total operating time.
4.5
4.5. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 5 Operating room time [min].
4.6
4.6. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 6 Conversion to another approach.
4.7
4.7. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 7 Estimated blood loss.
4.8
4.8. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 8 Quality of life (6 weeks).
4.9
4.9. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 9 Quality of life (6 months).
4.10
4.10. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 10 Re‐admission.
4.11
4.11. Analysis
Comparison 4 Robot‐assisted surgery for endometriosis versus conventional laparoscopic surgery, Outcome 11 Pain at 6 months.

Update of

References

References to studies included in this review

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Deimling 2017 {published data only}
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LAROSE 2017 {published data only}
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Lonnerfors 2014 {published data only}
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Maenpaa 2016 {published data only}
    1. Mäenpää MM, Nieminen K, Tomás EI, Laurila M, Luukkaala TH, Mäenpää JU. Robotic‐assisted vs traditional laparoscopic surgery for endometrial cancer: a randomized controlled trial. American Journal of Obstetrics and Gynecology 2016;215(5):588.e1‐7. - PubMed
Paraiso 2011 {published data only}
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Paraiso 2013 {published data only}
    1. Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, et al. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. American Journal of Obstetrics and Gynecology 2013;208(5):368.e361‐368.e367. - PubMed
RASHEC 2013 {published data only}
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Sarlos 2010 {published data only}
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References to studies excluded from this review

Advincula 2007 {published data only}
    1. Advincula AP, Xiao Xu, Goudeau S, Ransom SB. Robot‐assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short‐term surgical outcomes and immediate costs. Journal of Minimally Invasive Gynecology 2007;14(6):698‐705. - PubMed
Arms 2015 {published data only}
    1. Arms RG 3rd, Sun CC, Burzawa JK, Fleming ND, Nick AM, Rallapalli V, et al. Improvement in quality of life after robotic surgery results in patient satisfaction. Gynecologic Oncology 2015;138(3):727‐30. - PMC - PubMed
Asciutto 2015 {published data only}
    1. Asciutto KC, Kalapotharakos G, Löfgren M, Högberg T, Borgfeldt C. Robot‐assisted surgery in cervical cancer patients reduces the time to normal activities of daily living. Acta Obstetricia et Gynecologica Scandinavica 2015;94(3):260‐5. - PubMed
Bell 2008 {published data only}
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Best 2014 {published data only}
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Boggess 2008a {published data only}
    1. Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, et al. A case‐control study of robot‐assisted type III radical hysterectomy with pelvic lymph node dissection compared with open radical hysterectomy. American Journal of Obstetrics and Gynecology 2008;199(4):357.e1‐7. - PubMed
Boggess 2008b {published data only}
    1. Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, et al. A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy. American Journal of Obstetrics and Gynecology 2008;199(4):360.e1‐9. - PubMed
Bogliolo 2015 {published data only}
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Campos 2013 {published data only}
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Cantrell 2010 {published data only}
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Cardenas‐Goicoechea 2010 {published data only}
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Chen 2015 {published data only}
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Chong 2016 {published data only}
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Culligan 2010 {published data only}
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DeNardis 2008 {published data only}
    1. DeNardis SA, Holloway RW, Bigsby GE 4th, Pikaart DP, Ahmad S, Finkler NJ. Robotically assisted laparoscopic hysterectomy versus total abdominal hysterectomy and lymphadenectomy for endometrial cancer. Gynecologic Oncology 2008;111(3):412‐7. [PUBMED: 18834620] - PubMed
Denstad 2017 {published data only}
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Desille‐Gbaguidi 2013 {published data only}
    1. Desille‐Gbaguidi H, Hebert T, Paternotte‐Villemagne J, Gaborit C, Rush E, Body G. Overall care cost comparison between robotic and laparoscopic surgery for endometrial and cervical cancer. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2013;171(2):348‐52. - PubMed
Diaz‐Feijoo 2016 {published data only}
    1. Díaz‐Feijoo B, Correa‐Paris A, Pérez‐Benavente A, Franco‐Camps S, Sánchez‐Iglesias JL, Cabrera S, et al. Prospective randomized trial comparing transperitoneal versus extraperitoneal laparoscopic aortic lymphadenectomy for surgical staging of endometrial and ovarian cancer: the STELLA trial. Annals of Surgical Oncology 2016;23(9):2966‐74. - PubMed
Eklind 2015 {published data only}
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Estape 2009 {published data only}
    1. Estape R, Lambrou N, Diaz R, Estape E, Dunkin N, Rivera A. A case matched analysis of robotic radical hysterectomy with lymphadenectomy compared with laparoscopy and laparotomy. Gynecologic Oncology 2009;113(3):357‐61. [PUBMED: 19345987] - PubMed
Falik 2017 {published data only}
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Gehrig 2008 {published data only}
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Geisler 2010 {published data only}
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Gocmen 2013 {published data only}
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Hoekstra 2009 {published data only}
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Iavazzo 2016 {published data only}
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Jung 2010 {published data only}
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Kho 2009 {published data only}
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Kim 2015 {published data only}
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Kivnick 2013 {published data only}
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Lambaudie 2008 {published data only}
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Lambaudie 2010 {published data only}
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Persson 2009 {published data only}
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Seamon 2009b {published data only}
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Somashekhar 2014 {published data only}
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References to ongoing studies

Kjolhede 2012 {published data only}
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Lauszus 2017 {published data only}
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Narducci 2010 {published data only}
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References to other published versions of this review

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