Randomized trials in robotic surgery: a practical impossibility?

Collins, Sarah A.

doi:10.1007/s00192-010-1220-3

Cited by 6 publications

(3 citation statements)

References 7 publications

(7 reference statements)

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“…The difficulty in performing a randomised control trial (RCT) in robotic surgery was described in an editorial by Collins et al. They describe the negative effect of patient, surgeon, and healthcare system bias on RCT, and highlight the role of prospective cohort studies in robot‐assisted surgery . The strength of this prospective European bi‐centre cohort study was to address these issues and, in particular, to provide results from homogeneous groups of procedures performed by robotically experienced surgeons.…”

Section: Introductionmentioning

confidence: 99%

Robot‐assisted surgery for the management of apical prolapse: a bi‐centre prospective cohort study

Zanten

Koops

O’Sullivan

et al. 2019

BJOG

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Objective Robot-assisted surgery is a recognised treatment for pelvic-organ prolapse. Many of the surgical subgroup outcomes for apical prolapse are reported together, leading to a paucity of homogenous data.Design Prospective observational cohort study (NCT01598467, clinicaltrials.gov) assessing outcomes for homogeneous subgroups of robot-assisted apical prolapse surgery.Setting Two European tertiary referral hospitals.Population Consecutive patients undergoing robot-assisted sacrocolpopexy (RASC) and supracervical hysterectomy with sacrocervicopexy (RSHS).Methods Anatomical cure (simplified Pelvic Organ Prolapse Quantification, sPOPQ, stage 1), subjective cure (symptoms of bulge), and quality of life (Pelvic Floor Impact Questionnaire, PFIQ-7).Main outcome measures Primary outcome: anatomical and subjective cure. Secondary outcomes: surgical safety and intraoperative variables.Results A total of 305 patients were included (RASC n = 188; RSHS n = 117). Twelve months follow-up was available for 144 (RASC 76.6%) and 109 (RSHS 93.2%) women. Anatomical success of the apical compartment occurred for 91% (RASC) and in 99% (RSHS) of the women. In all compartments, the success percentages were 67 and 65%, respectively. Most recurrences were in the anterior compartment [15.7% RASC (symptomatic 12.1%); 22.9% RSHS (symptomatic 4.8%)]. Symptoms of bulge improved from 97.4 to 17.4% (P < 0.0005). PFIQ-7 scores improved from 76.7 AE 62.3 to 13.5 AE 31.1 (P < 0.0005). The duration of surgery increased significantly for RSHS [183.1 AE 38.2 versus 145.3 AE 29.8 (P < 0.0005)]. Intraoperative complications and conversion rates were low (RASC, 5.3 and 4.3%; RSHS, 0.0 and 0.0%). Four severe postoperative complications occurred after RASC (2.1%) and one occurred after RSHS (1.6%).Conclusions This is the largest reported prospective cohort study on robot-assisted apical prolapse surgery. Both procedures are safe, with durable results.

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Section: Introductionmentioning

confidence: 99%

Robot‐assisted surgery for the management of apical prolapse: a bi‐centre prospective cohort study

Zanten

Koops

O’Sullivan

et al. 2019

BJOG

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“…Is it therefore ethical to deny patients the benefits of minimally invasive surgery solely based on cost? Moreover, the findings of Collins and Tulikangas are interesting: randomised trials with new techniques are difficult to perform because patients would like to have the new technique, regardless of the evidence. In their study, the overwhelming majority opted to have the newer robotic technique.…”

Section: Ethical Issuesmentioning

confidence: 99%

Robotic surgery in gynaecology

Nair

Killicoat

Ind

2016

The Obstetric & Gynaecologis

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Robotic surgery has gained popularity in the last decade and the da Vinciâ Surgical System has been increasingly used for complex gynaecological surgery. The advantages of robotic surgery over conventional laparoscopic surgery are: greater degree of movement, precise dissection, 3D vision, tremor filtration and a shorter learning curve. The disadvantages are mainly the high cost and lack of haptic feedback. The current role of robotics in gynaecological surgery. Learning objectivesTo provide an overview of the advantages and drawbacks of robotic surgery over conventional open and laparoscopic surgery.To review the latest evidence and evaluate the role of robotics in general gynaecology and the subspecialties, including oncology and urogynaecology. To discuss training issues for individuals and for theatre teams. Ethical issuesIs it ethical to deny patients who would benefit from robotic surgery this option because of the cost?Robotic surgery offers all of the advantages of minimally invasive surgery, including decreased blood loss, quicker recovery, decreased length of hospital stay, less pain and ª 2016 Royal College of Obstetricians and Gynaecologists

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“…The difficulties of recruiting for an RCT comparing robotic with traditional approaches were outlined in an editorial in this journal. The editorial focused particularly on the roles of patient, physician, and hospital bias [4]. A health technology paper in the late 1980s observed that with new technologies: "it's always too early to do a randomized controlled trial until it's suddenly too late" [5].…”

Section: The Presentmentioning

confidence: 99%

Patents running out: time to take stock of robotic surgery

O’Reilly

2014

Int Urogynecol J

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Randomized trials in robotic surgery: a practical impossibility?

Cited by 6 publications

References 7 publications

Robot‐assisted surgery for the management of apical prolapse: a bi‐centre prospective cohort study

Robot‐assisted surgery for the management of apical prolapse: a bi‐centre prospective cohort study

Robotic surgery in gynaecology

Patents running out: time to take stock of robotic surgery

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