BMJ Surgery Interventions Health Technologies最新文献

Objective: To assess the impact of iterative changes in preoperative and postoperative biopsy techniques on the outcomes of men undergoing the precision prostatectomy procedure. Precision prostatectomy is a novel surgical treatment for prostate cancer that aims to maximally preserve erectogenic nerves via partial preservation of the prostate capsule.

Design: Retrospective.

Setting: Single tertiary care center.

Participants: This study included 120 patients who consented to undergo prostate cancer treatment with the precision prostatectomy procedure. Patients were originally enrolled in one of two separate prospective protocols studying precision prostatectomy.

Interventions: Preoperatively, 60 patients were screened with transrectal (TR) biopsy and 60 were screened by transperineal (TP) biopsy. Ultimately, 117 patients underwent precision prostatectomy. Of the 43 postoperative biopsies, 19 were TR; 17 were TP with ultrasound; and 7 were TP with microultrasound (mUS).

Main outcome measures: Preoperatively, we evaluated whether the transition to TP biopsy was associated with differences in postoperative treatment failure defined as a neoplasm-positive postoperative biopsy. Postoperative biopsies were compared with respect to their ability to sample the remnant tissue, specifically percentage of cores positive for prostate tissue.

Results: Preoperatively, 9/60 (15%) positive postoperative biopsies occurred in the TR group and 6/60 (10%) in the TP group; Kaplan-Meier survival estimates did not differ between groups (p=0.69 by log rank). Postoperatively, the numbers of cores positive for prostate tissue were 99/160 (62%), 63/107 (59%), and 36/39 (92%) in the TR biopsy, TP with ultrasound, and TP with mUS groups, respectively; this difference was statistically significant versus the rate in the TR and standard TP groups (p=0.0003 and 0.0002).

Conclusion: We found no significant improvement in patient screening, preoperatively-though limited by small sample size and relatively short follow-up. The incorporation of high-frequency mUS for postoperative biopsies improved the ability to sample the remnant tissue with a higher efficiency.

Objective: Although many studies have been performed, no consensus exists as to the ideal entry for laparoscopic gynecologic surgery. We sought out to compare the safety of direct trocar insertion with that of the Veress needle entry technique in gynecologic laparoscopic surgery.

Design: Systematic review with meta-analysis.

Setting: We searched Medline, ClinicalTrials.Gov, PubMed, Cochrane CENTRAL, SCOPUS, and Web of Science from their inception through 31 July 2021 for relevant studies. We included only controlled trials and ultimately seven trials were included in our meta-analysis.

Participants: Inclusion criteria included women undergoing gynecological laparoscopic surgery.

Intervention: The intervention of direct trocar insertion technique compared with Veress needle entry technique.

Main outcome measures: We compared five different outcomes associated with the efficacy and complications of laparoscopic entry.

Results: The pooled analysis showed that Veress needle entry was associated with a significant increase in the incidences of extraperitoneal insufflation (RR=0.177, 95% Cl (0.094 to 0.333), p<0.001), omental injury (RR=0.418, 95% Cl (0.195 to 0.896), p<0.001), failed entry (RR=0.173, 95% Cl (0.102 to 0.292), p<0.001), and trocar site infection (RR=0.404, 95% Cl (0.180 to 0.909), p<0.029). There was no significant difference between the two groups regarding the visceral injury (RR=0.562, 95% Cl (0.047 to 6.676), p<0.648).

Conclusions: When excluding all data apart from gynecologic surgery, the Veress needle entry technique may have an increased incidence of some, but not all complications of laparoscopic entry. It may also have a higher incidence of failed entry compared with direct entry techniques. Care should be taken in extrapolating these general results to specific surgeon experience levels.

Trial registration number: CRD42021273726.

Background: Diabetic foot ulceration (DFU) has devastating complications and a lifetime occurrence of 15%-34%. Debridement of DFU is regarded as an intervention that accelerates ulcer healing and may reduce complications including amputations, infections, and poor quality of life (QoL), which have serious public health and clinical implications. A systematic review (SR) of SRs and of randomized controlled trials (RCTs) with meta-analyses (MAs) on debridement of DFU that synthesizes all human experimental evidence is warranted.

Objectives: Are debridement methods in DFU beneficial over other forms and standard gauze dressings (control condition) in these outcomes?

Study eligibility criteria: All SRs/MAs/RCTs comparing debridement methods for DFU with alternative methods of debridement and with control.

Data sources: Cochrane Wounds Group Specialized Register, Cochrane Central Register of Controlled Trials (Cochrane Library), Ovid MEDLINE, PubMed, EMBASE, EBSCO, CINAHL, and Web of Science.

Participants and interventions: Adults with type 1/2 diabetes with DFU and any debridement method compared with alternative debridement methods or control.

Main outcomes: Amputation rates, wound infections, QoL, proportion of ulcers healed, time to complete healing, ulcer recurrence, and treatment cost.

Study selection and analysis: Data extraction/synthesis by two independent reviewers pooled using a random-effects model with sensitivity analysis.

Results: 10 SRs were retrieved and reported qualitatively. Six SRs included MAs. This SR included 30 studies, with 2654 participants, using 19 debridement combinations. The debridement methods were compared with findings pooled into MAs. Meta-regression (MR) did not identify significant predictors/moderators of outcomes.

Limitations: The studies may have been under-powered. The inclusion/exclusion criteria varied and the increased risk of bias contributed to low-quality evidence.

Discussion/conclusion: Weak evidence exists that debridement methods are superior to other forms of debridement or control in DFU.

Implications: Researchers should follow standardized reporting guidelines (Consolidated Standards of Reporting Trials). Clinicians/investigators could use the findings from this SR/MA/MR in guiding patient-individualized decision making and designing future RCTs.

Objectives: Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new, fully integrated, compact three-dimensional laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. This IDEAL Stage 1 and 2a study assessed its safety, reliability and potential efficacy particularly for single incision laparoscopic surgery and vaginal natural orifice transluminal endoscopic surgery.

Design: Prospective single-institution, single-surgeon study.

Setting: The study was conducted in a multispecialty hospital.

Participants: Women aged 18-70 years scheduled for gynecological laparoscopic surgery were invited to participate. An information sheet and consent was available for the women and an informed consent was obtained. Thirteen participants completed this study.

Interventions: The laparoscopic procedures were done in the usual manner. The only difference was the Sirius System was used in place of the conventional laparoscope. All other procedures and instruments remained the same.

Main outcome measures: Primary outcome was the proportion of women who successfully completed the intended procedure using the Sirius System without conversion to another camera system, camera users and surgeon's view and experience, and iterations and modifications to the system. Secondary outcomes were the incidence of intraoperative and postoperative complications during the first 6 weeks following surgery, and duration of surgery.

Results: 85% (11/13) of women had their procedure completed successfully using the Sirius System. Two women required immediate conversion to the conventional laparoscope due to technical issues. There were no intraoperative complications. Users agreed that the improved field of view was beneficial for laparoscopic surgery. Iterative improvements were made in the imaging quality, user interface and manufacturing quality.

Conclusions: Sirius System has early indications for safety and efficacy for intermediate and major minimally invasive laparoscopic procedures in gynecology. Further studies are needed to confirm it can replace a conventional laparoscope in the surgical workflow.

Trial registration number: NCT05048407.

Introduction: The postoperative period represents a time where patients are at a high-risk of morbidity, which warrants effective surveillance. While digital health interventions (DHIs) for postoperative monitoring are promising, a coordinated, standardized and evidence-based approach regarding their implementation and evaluation is currently lacking. This study aimed to identify DHIs implemented and evaluated in postoperative care to highlight research gaps and assess the readiness for routine implementation.

Methods: A systematic review will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify studies describing the implementation and evaluation of DHIs for postoperative monitoring published since 2000 (PROSPERO ID: CRD42021264289). This will encompass the Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and ClinicalTrials.gov databases, and manual search of bibliographies for relevant studies and gray literature. Methodological reporting quality will be evaluated using the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) reporting guideline relevant to the IDEAL stage of the study, and risk of bias will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Data will be extracted according to the WHO framework for monitoring and evaluating DHIs, and a narrative synthesis will be performed.

Discussion: This review will assess the readiness for implementation of DHIs for routine postoperative monitoring and will include studies describing best practice from service changes already being piloted out of necessity during the COVID-19 pandemic. This will identify interventions with sufficient evidence to progress to the next IDEAL stage, and promote standardized and comprehensive evaluation of future implementational studies.

Objective: Transesophageal echocardiography (TEE) is sometimes used to search for cardioembolic sources after ischemic stroke or transient ischemic attack (TIA). TEE visualizes some sources better than transthoracic echocardiography, but TEE is invasive and may cause aspiration. Few data exist on the risk of respiratory complications after TEE in patients who had stroke or TIA. Our objective was to determine whether TEE was associated with increased risk of respiratory failure in patients who had ischemic stroke or TIA.

Design: This is a retrospective cohort study using administrative data from inpatient and outpatient insurance claims collected by the US federal government's Centers for Medicare and Medicaid Services.

Setting: Hospitals and outpatient clinics throughout the USA.

Participants: 99 081 patients ≥65 years old hospitalized for out-of-hospital ischemic stroke or TIA, defined by validated International Classification of Disease-9/10 diagnosis codes and present-on-admission codes, using claims data from 2008 to 2018 in a random 5% sample of Medicare beneficiaries.

Main outcome measures: Acute respiratory failure, defined as endotracheal intubation and/or mechanical ventilation, starting on the first day after admission through 28 days afterward.

Results: Of 99 081 patients included in this analysis, 73 733 (74.4%) had an ischemic stroke and 25 348 (25.6%) a TIA. TEE was performed in 4677 (4.7%) patients and intubation and/or mechanical ventilation in 1403 (1.4%) patients. The 28-day cumulative risk of respiratory failure after TEE (1.4%; 95% CI 0.8% to 2.7%) was similar to that seen in those without TEE (1.4%; 95% CI 1.4% to 1.5%) (p=0.84). After adjustment for age, sex, race, Charlson comorbidities, diagnosis of stroke versus TIA, intravenous thrombolysis, and mechanical thrombectomy, TEE was not associated with an increased risk of respiratory failure (HR, 0.9; 95% CI 0.6 to 1.2).

Conclusions: In a cohort of older patients who had ischemic stroke or TIA, TEE was not associated with an increased risk of subsequent respiratory failure.

Epilepsy and epilepsy surgery lend themselves well to the application of machine learning (ML) and artificial intelligence (AI) technologies. This is evidenced by the plethora of tools developed for applications such as seizure detection and analysis of imaging and electrophysiological data. However, few of these tools have been directly used to guide patient management. In recent years, the Idea, Development, Exploration, Assessment, Long-Term Follow-Up (IDEAL) collaboration has formalised stages for the evaluation of surgical innovation and medical devices, and, in many ways, this pragmatic framework is also applicable to ML/AI technology, balancing innovation and safety. In this protocol paper, we outline the preclinical (IDEAL stage 0) evaluation and the protocol for a prospective (IDEAL stage 1/2a) study to evaluate the utility of an ML lesion detection algorithm designed to detect focal cortical dysplasia from structural MRI, as an adjunct in the planning of stereoelectroencephalography trajectories in children undergoing intracranial evaluation for drug-resistant epilepsy.

Objective: To identify and compare patient and procedural variables that are associated with a high radiation dose exposure and worse clinical outcomes between transradial arterial (TRA) and transfemoral arterial (TFA) approaches.

Design: This was a retrospective analysis.

Setting: A community hospital during the initial phase of adopting a TRA-first approach.

Participants: A resultant 215 subjects who only underwent diagnostic cerebral angiograms (DCA) after excluding all therapeutic procedures and patients under 18 years.

Interventions: Only DCA from 1 May 2018 to 31 January 2021.

Main outcome measures: We compared radiation exposure parameters (total fluoroscopy time (FT), total radiation dose (TD) and dose area product (DAP), number of vessels injected and Patient-Reported Global Health Physical and Mental Outcome Scores (PROGHS) at 30 days postprocedure between groups.

Results: FT was significantly greater in TRA compared with TFA (p<0.001). In addition, TRA had a significantly higher TD (p=0.002) and DAP (p=0.005) when compared with TFA. Analysis of only 6-vessel DCAs also showed that TRA had a significantly higher FT, DAP and TD in comparison to TFA. Despite observing a longer FT in TRA, results showed fewer vessels injected and a notably lower success rate in acquiring a 6-vessel DCA using the TRA. Further analysis of the effect of vessel number on FT using general linear models showed that with every increase of one vessel, the FT increases by 2.2 min for TRA (p<0.001; 95% CI 1.03 to 3.36) and by 1.3 min for TFA (p<0.001; 95% CI 0.72 to 1.83). There was no significant difference between groups in PROGHS mental and physical t-scores at 30 days postprocedure, even though our cohort showed a significantly greater percentage of TRA procedures done in the outpatient setting.

Conclusions: Adopting a TRA first approach for DCAs may be initially associated with a higher radiation dose for the patient. Better strategies and devices are needed to mitigate this effect.