A protocol for targeted B-lymphocyte depletion for the treatment of IgG4-related disease.

Objectives: To determine the clinical outcomes of patients with immunoglobulin 4-related disease (IgG4-RD) treated with a defined B cell depletion protocol using rituximab.

Methods: Patients were included if they had (1) an IgG4-RD diagnosis at Imperial College Healthcare NHS Trust between February 2017 and October 2022, and (2) >9 months of follow-up data available following the first rituximab dose. The rituximab protocol targeted B cell depletion to < 10 cells/microliter for a maintenance period of two years.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

Objective: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0).

Background: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety.

Methods: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate.

Perfect Registration Leads to Imperfect Performance: A Randomized Trial of Multimodal Intraoperative Image Guidance.

Objective: To compare surgical safety and efficiency of 2 image guidance modalities, perfect augmented reality (AR) and side-by-side unregistered image guidance (IG), against a no guidance control (NG), when performing a simulated laparoscopic cholecystectomy (LC).

Background: Image guidance using AR offers the potential to improve understanding of subsurface anatomy, with positive ramifications for surgical safety and efficiency. No intra-abdominal study has demonstrated any advantage for the technology.

Global trends in paediatric robot-assisted urological surgery: a bibliometric and Progressive Scholarly Acceptance analysis.

The inaugural robot-assisted urological procedure in a child was performed in 2002. This study aims to catalogue the impact of this technology by utilizing bibliographic data as a surrogate measure for global diffusion activity and to appraise the quality of evidence in this field. A systematic literature search was performed to retrieve all reported cases of paediatric robot-assisted urological surgery published between 2003 and 2016.

Predicting surgical outcome in patients with glioblastoma multiforme using pre-operative magnetic resonance imaging: development and preliminary validation of a grading system.

The lack of a simple, objective and reproducible system to describe glioblastoma multiforme (GBM) represents a major limitation in comparative effectiveness research. The objectives of this study were therefore to develop such a grading system and to validate it on patients who underwent surgical resection. A systematic review of the literature was performed to identify features on pre-operative magnetic resonance imaging (MRI) that predict the surgical outcome of patients with GBM.

Regulatory approval of new medical devices: cross sectional study.

Objective:  To investigate the regulatory approval of new medical devices.

Design:  Cross sectional study of new medical devices reported in the biomedical literature.

Data Sources:  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices.

Fifty Years of Innovation in Plastic Surgery.

Background: Innovation has molded the current landscape of plastic surgery. However, documentation of this process only exists scattered throughout the literature as individual articles. The few attempts made to profile innovation in plastic surgery have been narrative, and therefore qualitative and inherently biased.

Making the Leap: the Translation of Innovative Surgical Devices From the Laboratory to the Operating Room.

Objective: To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation.

Summary Background Data: Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood.

Comparative Performance in Single-Port Versus Multiport Minimally Invasive Surgery, and Small Versus Large Operative Working Spaces: A Preclinical Randomized Crossover Trial.

Background: Surgical approaches such as transanal endoscopic microsurgery, which utilize small operative working spaces, and are necessarily single-port, are particularly demanding with standard instruments and have not been widely adopted. The aim of this study was to compare simultaneously surgical performance in single-port versus multiport approaches, and small versus large working spaces.

Methods: Ten novice, 4 intermediate, and 1 expert surgeons were recruited from a university hospital.

Robotic surgery in children: adopt now, await, or dismiss?

The role of robot-assisted surgery in children remains controversial. This article aims to distil this debate into an evidence informed decision-making taxonomy; to adopt this technology (1) now, (2) later, or (3) not at all. Robot-assistance is safe, feasible and effective in selected cases as an adjunctive tool to enhance capabilities of minimally invasive surgery, as it is known today.

Comparative effectiveness and safety of image guidance systems in surgery: a preclinical randomised study.

Background: Over the past decade image guidance systems have been widely adopted in specialties such as neurosurgery and otorhinolaryngology. Nonetheless, the evidence supporting the use of image guidance systems in surgery remains limited. New augmented reality systems offer the possibility of enhanced operating room workflow compared with existing triplanar image displays, but recent studies have highlighted several concerns, particularly the risk of inattentional blindness and impaired depth perception.

Robust ultrasound probe tracking: initial clinical experiences during robot-assisted partial nephrectomy.

Purpose: In order to assist in the identification of renal vasculature and tumour boundaries in robot-assisted partial nephrectomy, robust ultrasound probe calibration and tracking methods are introduced. Contemporaneous image guidance during these crucial stages of the procedure should ultimately lead to improved safety and quality of outcome for the patient, through reduced positive margin rates, segmental clamping, shorter ischaemic times and nephron-sparing resection.

Methods: Small KeyDot markers with circular dot patterns are attached to a miniature pickup ultrasound probe.

Assessing the impact of mass media public health campaigns. Be Clear on Cancer 'blood in pee': a case in point.

Objectives: To assess the impact on suspected cancer referral burden and new cancer diagnosis of Public Health England's recent Be Clear on Cancer 'blood in pee' mass media campaign.

Methods: A retrospective cohort study design was used. For two distinct time periods, August 2012 to May 2013 and August 2013 to May 2014, all referrals of patients deemed to be at risk of urological cancer by the referring primary healthcare physician to Imperial College NHS Healthcare Trust were screened.

Comparative effectiveness and safety of image guidance systems in neurosurgery: a preclinical randomized study.

Object: Over the last decade, image guidance systems have been widely adopted in neurosurgery. Nonetheless, the evidence supporting the use of these systems in surgery remains limited. The aim of this study was to compare simultaneously the effectiveness and safety of various image guidance systems against that of standard surgery.

Using preoperative imaging for intraoperative guidance: a case of mistaken identity.

Background: Surgical image guidance systems to date have tended to rely on reconstructions of preoperative datasets. This paper assesses the accuracy of these reconstructions to establish whether they are appropriate for use in image guidance platforms.

Methods: Nine raters (two experts in image interpretation and preparation, three in image interpretation, and four in neither interpretation nor preparation) were asked to perform a segmentation of ten renal tumours (four cystic and six solid tumours).

Technological innovation in neurosurgery: a quantitative study.

Object: Technological innovation within health care may be defined as the introduction of a new technology that initiates a change in clinical practice. Neurosurgery is a particularly technology-intensive surgical discipline, and new technologies have preceded many of the major advances in operative neurosurgical techniques. The aim of the present study was to quantitatively evaluate technological innovation in neurosurgery using patents and peer-reviewed publications as metrics of technology development and clinical translation, respectively.

Inattention blindness in surgery.

Background: Inattention blindness (IB) can be defined as the failure to perceive an unexpected object when attention is focussed on another object or task. The principal aim of this study was to determine the effect of cognitive load and surgical image guidance on operative IB.

Methods: Using a randomised control study design, participants were allocated to a high or low cognitive load group and subsequently to one of three augmented reality (AR) image guidance groups (no guidance, wireframe overlay and solid overlay).

da Vinci robot-assisted keyhole neurosurgery: a cadaver study on feasibility and safety.

The goal of this cadaver study was to evaluate the feasibility and safety of da Vinci robot-assisted keyhole neurosurgery. Several keyhole craniotomies were fashioned including supraorbital subfrontal, retrosigmoid and supracerebellar infratentorial. In each case, a simple durotomy was performed, and the flap was retracted.

Meta-analysis of robot-assisted vs conventional laparoscopic and open pyeloplasty in children.

Objective: To critically analyse outcomes for robot-assisted pyeloplasty(RAP) vs conventional laparoscopic pyeloplasty (LP) or open pyeloplasty (OP) by systematic review and meta-analysis of published data.

Patients And Methods: Studies published up to December 2013 were identified from multiple literature databases. Only comparative studies investigating RAP vs LP or OP in children were included.

Robotic versus non-robotic instruments in spatially constrained operating workspaces: a pre-clinical randomized crossover study.

Objective: To compare the effectiveness of robotic and non-robotic laparoscopic instruments in spatially constrained workspaces.

Materials And Methods: Surgeons performed intracorporeal sutures with various instruments within three different cylindrical workspace sizes. Three pairs of instruments were compared: 3-mm non-robotic mini-laparoscopy instruments; 5-mm robotic instruments; and 8-mm robotic instruments.