Surgical Quality Assurance Research Articles

Vascularsurgical Long-term Outcome - Comparison of Orthotopic and Extraanatomic Reconstructions in Unilateral Occlusions of Iliac Artery over 10 Years

In PAOD, several vascular regions are usually affected, the pelvic axis in 35% of cases. Interventional-radiological/endovascular or hybrid interventions have been established for recanalization, so that bypass procedures are increasingly taking a back seat, but are not losing their importance.To study unilateral iliac artery occlusions (inclusion criterion) that were repaired either by implantation of an orthotopic or extraanatomic bypass (oBP/eaBP).Over a defined period of time, the rate of open vessel, complications (frequency, type, severity) to characterize morbidity and mortality as well as the extent of clinical improvement after BP implantation were analyzed in a clinical-systematic, single-center observational study (for vascular surgical quality assurance and contribution to vascular medical-clinical health care research). The study method was not explicitly based on the STROBE criteria, but essentially corresponds to them.Over 10 years, 122 PAOD patients (50% in stage IIb-stage III and IV equally distributed; mean age: 63 [range, 44-87] years; majority ASA III) were included with the same number of reconstructions: 71 patients received an eaBP ("crossover"), 51 patients an iliacofemoral (orthotopic - oBP) bypass (neither significant difference regarding frequency nor number of risk factors per patient).The oBP is not superior to eaBP with regard to the analysis parameters of openness, complication rate and mortality. Furthermore, extraanatomic revascularization does not have to be reserved for polymorbid patients only.

Development of a reliable surgical quality assurance tool for gastrectomy in oncological trials

BackgroundDespite its recognized importance, there is currently no reliable tool for surgical quality assurance (SQA) of gastrectomy in surgical oncology. The aim of this study was to develop an SQA tool for gastrectomy and to apply this tool within the ADDICT Trial in order to assess the extent and completeness of lymphadenectomy.MethodsThe operative steps for D1+ and D2 gastrectomy have been previously described in the literature and ADDICT trial manual. Two researchers also performed fieldwork in the UK and Japan to document key operative steps through photographs and semi-structured interviews with expert surgeons. This provided the steps that were used as the framework for the SQA tool. Sixty-two photographic cases from the ADDICT Trial were rated by three independent surgeons. Generalizability (G) theory determined inter-rater reliability. D-studies examined the effect of varying the number of assessors and photographic series they rated. Chi-square assessed intra-rater reliability, comparing how the individual assessor’s responses corresponded to their global rating for extent of lymphadenectomy.ResultsThe tool comprised 20 items, including 19 anatomical landmarks and a global rating score. Overall reliability had G-coefficient of 0.557. Internal consistency was measured with a Cronbach’s alpha score of 0.869 and Chi-square confirmed intra-rater reliability for each assessor as < 0.05.ConclusionsA photographic surgical quality assurance tool is presented for gastrectomy. Using this tool, the assessor can reliably determine not only the quality but also the extent of the lymphadenectomy performed based on remaining anatomy rather than the excised specimen.

Adoption of routine surgical video recording: a nationwide freedom of information act request across England and Wales

Surgical video contains data with significant potential to improve surgical outcome assessment, quality assurance, education, and research. Current utilisation of surgical video recording is unknown and related policies/governance structures are unclear. A nationwide Freedom of Information (FOI) request concerning surgical video recording, technology, consent, access, and governance was sent to all acute National Health Service (NHS) trusts/boards in England/Wales between 20th February and 20th March2023. 140/144 (97.2%) trusts/boards in England/Wales responded to the FOI request. Surgical procedures were routinely recorded in 22 trusts/boards. The median estimate of consultant surgeons routinely recording their procedures was 20%. Surgical video was stored on internal systems (n=27), third-party products (n=29), and both (n=9). 32/140 (22.9%) trusts/boards ask for consent to record procedures as part of routine care. Consent for recording included non-clinical purposes in 55/140 (39.3%) trusts/boards. Policies for surgeon/patient access to surgical video were available in 48/140 (34.3%) and 32/140 (22.9%) trusts/boards, respectively. Surgical video was used for non-clinical purposes in 64/140 (45.7%) trusts/boards. Governance policies covering surgical video recording, use, and/or storage were available from 59/140 (42.1%) trusts/boards. There is significant heterogeneity in surgical video recording practices in England and Wales. A minority of trusts/boards routinely record surgical procedures, with large variation in recording/storage practices indicating scope for NHS-wide coordination. Revision of surgical video consent, accessibility, and governance policies should be prioritised by trusts/boards to protect key stakeholders. Increased availability of surgical video is essential for patients and surgeons to maximally benefit from the ongoing digital transformation of surgery. KL is supported by an NIHR Academic Clinical Fellowship and acknowledges infrastructure support for this research from the National Institute for Health Research (NIHR) Imperial Biomedical Research Centre (BRC).

Can natural language processing be effectively applied for audit data analysis in gynaecological oncology at a UK cancer centre?

BackgroundThe British Gynaecological Cancer Society (BGCS) has highlighted the disparity of ovarian cancer outcomes in the UK compared to other European countries. Therefore, cancer quality assurance audits and subspecialty training are important in improving the UK standard of care for these patients. The current workforce crisis afflicting the NHS creates difficulty in dedicating teams of clinicians to these audits. We present a single institution study to evaluate if NLP-generated code can improve the efficiency of ovarian cancer and subspeciality reaccreditations audits. We used the chat bot Google Bard to write Visual Basic Applications algorithms that utilise Excel files from electronic health records. MethodsPrimary ovarian cancer data from 2019 to 2022 was retrospectively collected from the Cambridge University Hospital electronic health records. The surgical subspecialty reaccreditation audit analysed the 2022 surgical database. A modular coding approach with Google Bard was applied to generate audit algorithms. The time to complete these current audits was compared against the 2016 ovarian cancer and 2020 subspeciality reaccreditation audits. ResultsThe previous ovarian cancer audit conducted in 2016 required 3 clinicians for the 135 cases and data collection required 1800 min. Data analysis was completed in 300 min. The current ovarian cancer audit allocated 2 clinicians to the 600 surgical cases. Data collection was completed in 3120 min, 3360 min for code development and 720 min for testing. The 2020 subspecialty reaccreditation audit was completed in 360 min. The 2022 subspecialty reaccreditation audit was completed in 1680 min, with 960 min for code development, 240 for debugging and 480 min for testing. ConclusionWe have demonstrated that NLP-generated code can significantly increase the efficiency of surgical quality assurance audits by eliminating the need for manual data analysis. With the current trajectory of NLP development, increasingly complex algorithms can be developed with minimal programming knowledge.

HPB P24 Quality assurance within multicentre randomised controlled trials of surgical interventions for pancreatic cancer: a systematic review

Abstract Background Pancreatic cancer surgery is a complex intervention, with numerous studies exploring variations in approach to curative resection with the aim of improving outcomes. Multicentre randomised controlled trials (RCTs) represent the gold standard for evaluating these technical modifications. However, variations in how surgical intervention are delivered across trial sites and individual surgeons can influence results. Surgical quality assurance mechanisms within trial designs attempt to mitigate this by ensuring standardised, high-quality technique and reducing heterogeneity of procedures. This systematic review aimed to identify approaches to quality assurance within multicentre randomised controlled trials of surgical interventions for pancreatic cancer. Methods A systematic review was performed by searching MEDLINE and Embase databases between 1st January 2000 and 18th December 2022. Articles were deemed eligible for inclusion if they were a multicentre RCT and evaluated a surgical intervention, technique modification or variation in approach to surgical resection for pancreatic cancer. Data was extracted from included studies using a semi-structured form, with consideration of four prospectively defined quality assurance domains: i) surgical intervention and co-interventions description, ii) surgical technique standardisation, iii) performance monitoring methods, iv) surgeon/ unit credentialing methods. Results A total of 1970 studies were identified from the initial search, of which 44 trials were deemed eligible for inclusion. Thirty-six RCTs (81.8%) provided description of the intervention and/or co-intervention. Attempts to standardise technique were described in 33 RCTs (75.0%). However, only 4 trials (9.1%) deconstructed the intervention into its constituent components. Twelve studies (27.3%) described methods used to monitor performance and adherence to the intervention. The most common approaches used were intra-operative photographs (n=7; 15.9%), surgeon self-declaration (n=3; 6.8%), and pathological specimen review (n=2; 4.5%). Ten studies (22.7%) used credentialing methods based on unit entry criteria. Conclusions This study provides important data on the utilisation of methods of surgical quality assurance within pancreatic RCTs. With the exception of intervention description, compliance to the remaining domains of quality assurance was low. This may compromise the extent to which observed differences in clinical outcomes are due to the technique being evaluated within these trials. Confidence in the results of future RCTs would be improved by enhanced quality assurance across the four domains described.

OGC O03 Evolution in Laparoscopic Gastrectomy from a Randomized Controlled Trial through National Clinical Practice

Abstract Background Following Randomized Controlled Trials (RCT), the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. The aim of this present study was to examine the influence of the LOGICA RCT upon the practice and outcomes from laparoscopic gastrectomy within the Netherlands. Methods Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012–2021), and the LOGICA RCT from (2015–2018). Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes with the LOGICA RCT and DUCA datasets. These analyses were repeated to assess the effect of laparoscopic gastrectomy upon outcomes before, during, and after the LOGICA trial in the DUCA dataset. Results In total, 211 patients from the LOGICA RCT (105 open vs. 106 laparoscopic) and 4,131 patients from the DUCA dataset (1884 open vs. 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% of patients in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift towards a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction on overall complications (aOR:0.62; 95%CI:0.46-0.82), severe complications (aOR:0.64; 95%CI:0.46-0.90) and cardiac complications (aOR:0.51; 95%CI:0.30-0.89) after the LOGICA trial. Conclusions The wider benefits of the LOGICA trial include safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance programme in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.

Methods of quality assurance in multicenter trials in laparoscopic fundoplication for gastroesophageal reflux disease.

Operative performance may affect the internal and external validity of randomized trials. The aim of this study was to review the use of surgical quality assurance mechanisms of published trials on laparoscopic anti-reflux surgery, with the objective to appraise their internal (research quality) and external validity (applicability to the clinical setting). Building upon a previous systematic review and network meta-analysis published by the authors, Medline, Embase, AMED, CINAHL, CENTRAL, and OpenGrey databases were searched for randomized control trials comparing different methods of laparoscopic anti-reflux surgery for the management of gastroesophageal disease. Quality assurance in individual studies was appraised using a specified framework addressing surgeon accreditation, procedure standardization, and performance monitoring. In total, 2276 articles were screened to obtain 43 publications reporting 29 randomized controlled trials. Twenty-five out of 43 (58.1%) articles reported the number of participating centers and surgeons involved. Additionally, only 21/43 (48.8%) of articles reported consistent use of a bougie, while 23/43 (53.5%) of articles reported consistent division of the short gastric arteries during fundoplication. Surgical experience and credentials were stated in half of the studies. Standardization of the technique was reported in almost 70% of cases, whereas operative notes or video was submitted in one fourth of the studies. Monitoring of the operative performance during the trial was not documented in most of the trials (62%). Surgical quality assurance in randomized trials on laparoscopic anti-reflux surgery is insufficient, which does not allow appraisal of the internal and external validity of this research. With improved reporting, trials assessing the use of laparoscopic anti-reflux surgery will enable surgeons to make informed treatment decisions to enhance patient care in the surgical management of GERD.

Establishment of a Cardiothoracic Surgical Clinical Quality Assurance Committee in Queensland Public Hospitals

Establishment of a Cardiothoracic Surgical Clinical Quality Assurance Committee in Queensland Public Hospitals

Eugene Nicholas Myers' Lecture on Head and Neck Cancer, 2020: The Surgeon as a Prognostic Factor in Head and Neck Cancer Patients Undergoing Surgery.

This paper is a transcript of the 29 th Eugene N. Myers, MD International Lecture on Head and Neck Cancer presented at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in 2020. By the end of the 19 th century, the survival rate in treated patients was 10%. With the improvements in surgical techniques, currently, about two thirds of patients survive for > 5 years. Teamwork and progress in surgical reconstruction have led to advancements in ablative surgery; the associated adjuvant treatments have further improved the prognosis in the last 30 years. However, prospective trials are lacking; most of the accumulated knowledge is based on retrospective series and some real-world data analyses. Current knowledge on prognostic factors plays a central role in an efficient treatment decision-making process. Although the influence of most tumor- and patient-related prognostic factors in head and neck cancer cannot be changed by medical interventions, some environmental factors-including treatment, decision-making, and quality-can be modified. Ideally, treatment strategy decisions should be taken in dedicated multidisciplinary team meetings. However, evidence suggests that surgeons and hospital volume and specialization play major roles in patient survival after initial or salvage head and neck cancer treatment. The metrics of surgical quality assurance (surgical margins and nodal yield) in neck dissection have a significant impact on survival in head and neck cancer patients and can be influenced by the surgeon's expertise. Strategies proposed to improve surgical quality include continuous performance measurement, feedback, and dissemination of best practice measures.

Patterns of Major Frozen Section Interpretation Error: An In-Depth Analysis From a Complex Academic Surgical Pathology Practice.

To establish baseline error rates due to misinterpretation and to identify scenarios in which major errors were most common and potentially preventable. Our database was queried over a 3-year period for major discrepancies due to misinterpretation. These were stratified by histomorphologic setting, service, availability/type of prior material, and years of experience and subspecialization of the interpreting pathologist. The overall discordance rate between frozen section (FS) and final diagnoses was 2.9% (199/6,910). Seventy-two errors were due to interpretation, of which 34 (47.2%) were major. Major error rates were highest on the gastrointestinal and thoracic services. Of major discrepancies, 82.4% were rendered in subdisciplines outside those of the FS pathologist. Pathologists with fewer than 10 years' experience made more errors than those with more experience (55.9% vs 23.5%, P = .006). Major error rates were greater for cases without previous material compared to those with a prior glass slide (47.1% vs 17.6%, P = .009). Common histomorphologic scenarios in which disagreements were made involved discriminating mesothelial cells from carcinoma (20.6%) and accurately recognizing squamous carcinoma/severe dysplasia (17.6%). To improve performance and decrease future misdiagnoses, monitoring discordances should be a continuous component of surgical pathology quality assurance programs.

Relation between surgical oncologic quality indicators for papillary thyroid cancer.

Background:It remains unclear how thyroid surgical oncologic quality indicators (TSOQIs) are related to each other, and how to best interpret and apply these measures within the context of surgical quality assurance. We aimed to examine the relation between 3 TSOQIs: postoperative serum thyroglobulin level, 24-hour radioactive iodine uptake (RAIU) and metastatic lymph node ratio (MLNR).Methods:We conducted a retrospective review of patients who underwent total thyroidectomy for treatment of papillary thyroid cancer (PTC) performed by a single high-volume thyroid surgeon at a tertiary referral centre between 2012 and 2017. To establish the strength of correlation between pairs of quality indicators and the MACIS (metastasis, age, completeness of resection, invasion and size) prognostic score, we performed tests of normality and used the Spearman correlation coefficient to determine the correlation of nonnormal data containing outliers.Results:A total of 139 patients with PTC were included in the study. Their mean MACIS score was 5.0 (standard deviation 1.5). Fifteen patients had high-risk thyroid cancer (MACIS score > 6.99). A weak correlation was found between serum thyroglobulin level and RAIU (rs = 0.27, p = 0.006) and a moderate correlation was found between serum thyroglobulin level and MLNR (rs = 0.40 p = 0.002). A weak correlation between serum thyroglobulin level and MACIS score was also observed (rs = 0.20, p = 0.05).Conclusion:Based on our findings, we propose that the postoperative serum thyroglobulin level represents the quality metric that has the most clinical utility because it is measurable in all patients and also correlates with both RAIU and MLNR. With further research, surgeons seeking to evaluate the oncologic quality of thyroidectomy performed for PTC may consider applying a quality indicator to their future practice.

Surgical quality assurance at expanding health networks: A qualitative study

BackgroundEven after decades of network expansion and increased care being delivered within health networks, health network expansion has not led to uniform improvements in patient outcomes and satisfaction. The reasons for the lack of universal surgical quality improvement are unclear. This study used qualitative methods to understand the nuances that affect the variation in network-level surgical quality assurance and provides strategies that surgical leaders use to improve surgical quality at expanding health networks. MethodsThis qualitative study obtained information through 30 semistructured interviews conducted from August to December 2019 with surgical leaders whose institutions were associated with health networks. The topic of surgical quality assurance was an emergent theme that was informed by thematic analysis. ResultsInterviews with leaders revealed 3 themes with regard to surgical quality assurance. First, participants wanted standardized tools for quality measurement. Leaders frequently referred to the National Surgical Quality Improvement Program registry and shared electronic health records, but some networks did not have these available at all sites. Second, participants wanted an organizational structure that provides clear oversight over quality. Some leaders appointed executives or created committees to help manage quality improvement initiatives. Third, participants wanted a culture shift toward quality improvement. Many leaders faced resistance to quality initiatives from frontline clinicians; some implemented events and retreats to help garner support and a culture of quality. ConclusionThese interviews offer critical insights into 3 domains that can be leveraged for sustained improvement and detail strategies that leaders used for surgical quality assurance at hospital networks.

Assurance of surgical quality within multicenter randomized controlled trials for bariatric and metabolic surgery: a systematic review

Surgical quality assurance methods aim to ensure standardization and high quality of surgical techniques within multicenter randomized controlled trials (RCTs), thereby diminishing the heterogeneity of surgery and reducing biases due to surgical variation. This study aimed to establish the measures undertaken to ensure surgical quality within multicenter RCTs investigating bariatric and metabolic surgery, and their influence upon clinical outcomes.An electronic literature search was performed from the Embase, Medline, and Web of Science databases to identify multicenter RCTs investigating bariatric and metabolic surgery. Each RCT was evaluated against a checklist of surgical quality measures within 3 domain: (1) standardization of surgical techniques; (2) credentialing of surgical experience; and (3) monitoring of performance. Outcome measures were postoperative weight change and complications.Nineteen multicenter RCTs were included in the analysis. Three studies undertook pretrial education of surgical standard. Fourteen studies described complete standardization of surgical techniques. Four studies credentialed surgeons by case volume prior to enrollment. Two studies used intraoperative or video evaluation of surgical technique prior to enrollment. Only two studies monitored performance during the study. Although there were limited quality assurance methods undertaken, utilization of these techniques was associated with reduced overall complications. Standardization of surgery was associated with reduced re-operation rates but did not influence postoperative weight loss.The utilization of methods for surgical quality assurance are very limited within multicenter RCTs of bariatric and metabolic surgery. Future studies must implement surgical quality assurance methods to reduce variability of surgical performance and potential bias within RCTs.

P-OGC97 Development and piloting of surgical quality assurance methods for randomised controlled trials (RCTs): an example from a trial comparing laparoscopically assisted oesophagectomy vs. open oesophagectomy

Abstract Background RCTs in surgery are frequently criticised because the standard to which operations are performed (quality assurance - QA) is not considered during study design and delivery, risking performance bias. Lack of clarity about surgical QA may also influence the successful implementation of RCT results into routine practice, because it is unclear how procedures were undertaken. We developed QA measures for an RCT comparing laparoscopically assisted and open oesophagectomy (LAO and OO). Methods Five QA categories were developed during the pilot and applied to the main trial, using data from patients receiving their randomized allocation in each group: i) entry criteria for centres; ii) entry criteria for surgeons; surgical protocols for key components of LAO and OO with mandated, prohibited and flexible components, monitored using iii) case report forms (CRFs) to record protocol adherence; and iv) intra-operative photographs to demonstrate protocol adherence (using the visible anatomical structures to determine if the component had been fully completed); and v) lymph node count and length of oesophagus. Results 8 centres and 39 surgeons participated and met entry criteria. 145 (LAO) and 149 (OO) patients underwent their randomized surgical procedure. Key procedural components were reported as complete in CRFs at similar rates in both groups, with &amp;gt;70% undergoing mandated components. However, adherence assessed using photographs was consistently lower than the CRFs. For example, left gastric artery lymphadenectomies were reported as complete in &amp;gt; 98% CRFs (LAO and OO) whereas photographs found this to be complete in 42% (OO) and 54% (LAO). Median nodal count was similar in both groups (145 LAO=24.7, SD = 10.6 and 149 OO = 26.4, SD = 10.2) as was length of resected oesophagus. Conclusions Assessing surgical QA in a multi-centre trial is logistically challenging but feasible. Whilst video data from laparoscopic cases could be collected and assessed, it was not possible with open surgery. Understanding adherence to the study protocol using photographs in addition to CRFs was important because of marked differences between what surgeons reported had been undertaken and images of what had been achieved. It is recommended that surgical trials include QA processes to understand protocol adherence and examine performance bias between groups.

Introducing minimally invasive inguinal lymph node dissection in a UK tertiary skin cancer service: Initial experience & outcomes

We report the first UK case series of minimally invasive inguinal lymphadenectomy (MILND) for patients with metastatic cutaneous pathology. This was a retrospective, single-centre, single-surgeon cohort study. Twenty-one patients who underwent MILND from May 2015 to February 2019 were included. Demographic data, disease burden, and surgical quality assurance parameters were analysed. Median age was 69 (IQR: 58-76) with 14 women (66%) and 7 men (33%). Eighteen (85%) patients had melanoma with the rest having other skin malignancies. The median number of nodes resected was eight (IQR:6-11) and the median N-ratio was 0.18 [0.05-1.00]. The median surgical time for the procedure was 180 minutes (IQR: 147-225) Seven (33%) patients had complications--three trivial and four (19%) grade IIIB. Only one case (the first) was converted to an open procedure. We report the first UK series of MILND in a cutaneous oncology service. Our results show that MILND is a safe technique that can be introduced into a busy NHS practice with a structured training program, with surgical quality assurance outcomes identical to open inguinal lymphadenectomy. Our learning curve was similar to previously published data.

Esophagectomy or Total Gastrectomy for Siewert 2 Gastroesophageal Junction (GEJ) Adenocarcinoma? A Registry-Based Analysis

BackgroundsDue to a lack of randomized and large studies, the optimal surgical approach for Siewert 2 gastroesophageal junctional (GEJ) adenocarcinoma remains unknown. This population-based cohort study aimed to compare survival between esophagectomy and total gastrectomy for the treatment of Siewert 2 GEJ adenocarcinoma.MethodsData from the National Cancer Database (NCDB) from 2010 to 2016 was used to identify patients with non-metastatic Siewert 2 GEJ adenocarcinoma who received either esophagectomy (n = 999) or total gastrectomy (n = 8595). Propensity score-matching (PSM) and multivariable analyses were used to account for treatment selection bias.ResultsComparison of the unmatched cohort’s baseline demographics showed that the patients who received esophagectomy were younger, had a lower burden of medical comorbidities, and had fewer clinical positive lymph nodes. The patients in the unmatched cohort who received gastrectomy had a significantly shorter overall survival than those who received esophagectomy (median, 47 vs. 68 months [p < 0.001]; 5-year survival, 45 % vs. 53 %). After matching, gastrectomy was associated with significantly reduced survival compared with esophagectomy (median, 51 vs. 68 months [p < 0.001]; 5-year survival, 47 % vs. 53 %), which remained in the adjusted analyses (hazard ratio [HR], 1.22; 95 % confidence interval [CI], 1.09–1.35; p < 0.001).ConclusionsIn this large-scale population study with propensity-matching to adjust for confounders, esophagectomy was prognostically superior to gastrectomy for the treatment of Siewert 2 GEJ adenocarcinoma despite comparable lymph node harvest, length of stay, and 90-day mortality. Adequately powered randomized controlled trials with robust surgical quality assurance are the next step in evaluating the prognostic outcomes of these surgical strategies for GEJ cancer.

NRG Oncology HN006: Randomized phase II/III trial of sentinel lymph node biopsy versus elective neck dissection for early-stage oral cavity cancer.

TPS6093 Background: Since patients with early-stage oral cavity cancer (OCC; T1-2N0M0; AJCC 8th ed) have a 20-30% rate of occult nodal metastases despite clinical and radiographic assessment, standard of care treatment includes elective neck dissection (END). Many patients have comprehensive surgical management of the regional cervical nodal basin even though the majority of those necks (70-80%) will not contain disease. Assessment of draining first echelon lymph nodes by sentinel lymph node (SLN) biopsy (Bx), a less invasive surgical procedure, may provide an alternative to END, while potentially reducing morbidity and cost. A decisive clinical trial comparing SLN Bx versus END can focus the HNC clinical and research community and resources on establishing the standard of care for management of the neck in early-stage OCC. Methods: In order to address the efficacy of SLN Bx in this population, we recently activated an international multi-institutional phase II/III prospective trial randomizing patients to two surgical arms: SLN Bx and END. PET/CT is an integral imaging biomarker in this trial. A node-negative PET/CT study with central read is required before randomization. Patients with a positive PET/CT central result will remain in a registry to compare imaging findings with final neck pathology. Given the current evidence available regarding morbidity for SLN Bx versus END, the phase II will determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the Neck Dissection Impairment Index (NDII) shows a signal of superiority of SLN Bx compared to END. A total of 228 randomized patients with negative PET/CT for potential evaluation of shoulder-related morbidity with difference in 6-month NDII scores (minimum important difference ³7.5; one-sided a = 0.10; 90% power) will serve as the “Go/No-Go” decision to move forward into phase III. The phase III portion is a non-inferiority (NI) trial with disease-free survival (DFS) as the primary endpoint (NI margin hazard ratio 1.34 based on a 5% absolute difference in 2-year DFS; one-sided alpha 0.05; 80% power, and an interim look for efficacy at 67% of the events based on an O’Brien-Fleming boundary). The NDII at 6 months after surgery is a hierarchical co-primary endpoint for the phase III. Target accrual of phase III is 618 PET/CT negative patients, including those randomized in phase II (297 DFS events required for the final analysis). In addition to radiotherapy and imaging credentialing, quality assurance will include central pathology review of all negative SLN Bx cases and surgeon credentialing through an education course and SLN Bx and END case review by the surgical co-chairs. A surgical quality assurance working group will review all trial SLN Bx and END outcomes. As of 02/15/21, 7 patients have been screened and 6 of the planned 228 randomized patients in phase II have been enrolled. Clinical trial information: NCT04333537.

Keyframe Extraction From Laparoscopic Videos via Diverse and Weighted Dictionary Selection

Laparoscopic videos have been increasingly acquired for various purposes including surgical training and quality assurance, due to the wide adoption of laparoscopy in minimally invasive surgeries. However, it is very time consuming to view a large amount of laparoscopic videos, which prevents the values of laparoscopic video archives from being well exploited. In this paper, a dictionary selection based video summarization method is proposed to effectively extract keyframes for fast access of laparoscopic videos. Firstly, unlike the low-level feature used in most existing summarization methods, deep features are extracted from a convolutional neural network to effectively represent video frames. Secondly, based on such a deep representation, laparoscopic video summarization is formulated as a diverse and weighted dictionary selection model, in which image quality is taken into account to select high quality keyframes, and a diversity regularization term is added to reduce redundancy among the selected keyframes. Finally, an iterative algorithm with a rapid convergence rate is designed for model optimization, and the convergence of the proposed method is also analyzed. Experimental results on a recently released laparoscopic dataset demonstrate the clear superiority of the proposed methods. The proposed method can facilitate the access of key information in surgeries, training of junior clinicians, explanations to patients, and archive of case files.

P12 A systematic review of the reporting of surgical quality assurance and learning curve in robotic oesophagectomy

IntroductionThere is an increasing trend in novel robotic-assisted oesophagectomy in place of standard techniques, potentially due to its perceived technical benefits and improved post-operative outcomes. However, safety and efficacy remain uncertain and little is known about surgeons’ expertise in this complex procedure. This review aims to summarise the reporting of surgeons’ expertise in studies evaluating robotic oesophagectomy.MethodSystematic searches of OvidSP, MEDLINE and Cochrane Library were conducted using key words for robotic surgery and oesophageal cancer. Searches were limited to human studies published up to February 2020. Studies reporting any type of outcome for robotic oesophagectomy were included. Data on quality assurance measures (e.g. type of centre, surgeons’ experience, study entry criteria) and learning curve assessments were recorded.ResultsOf 954 abstracts screened, 226 full texts were reviewed and 103 included. Two studies were clinical trials. There were 85 (82.5%) single and 6 (5.8%) multi-centred institutions. Forty-four (43%) stated the type centre(s) involved: general (n = 1), specialist (n = 41) or mixed (n = 2). Thirteen (13%) reported centres’ caseload of robotic and non-robotic oesophagectomies within a defined period. Seven described surgeons’ prior experience in robotic oesophagectomy, and 5 described experience in open/laparoscopic surgery. Two stipulated entry criteria for surgeons (training qualification and number of robotic oesophagectomies performed). Eighteen (17%) assessed the learning curve through changes in operating time, complications and conversion rates.DiscussionThere is currently inadequate reporting on surgeons’ expertise in robotic oesophagectomy, making comparisons with standard techniques challenging. This highlights the need for better transparency when reporting surgical innovation, as outlined by the IDEAL framework.

Enhanced Training Benefits of Video Recording Surgery With Automated Hand Motion Analysis

BackgroundHand motion analysis by video recording during surgery has potential for evaluation of surgical performance. The aim was to identify how technical skill during open surgery can be measured unobtrusively by video recording during a surgical procedure. We hypothesized that procedural-step timing, hand movements, instrument use and Shannon entropy differ with expertise and training and are concordant with a performance-based validated individual procedure score.MethodsSurgeon and non-surgeon participants with varying training and levels of expertise were video recorded performing axillary artery exposure and control (AA) on un-preserved cadavers. Color-coded gloves permitted motion-tracking and automated extraction of entropy data from recordings. Timing and instrument-use metrics were obtained through observational video reviews. Shannon entropy measured speed, acceleration and direction by computer-vision algorithms. Findings were compared with individual procedure score for AA performanceResultsExperts had lowest entropy values, idle time, active time and shorter time to divide pectoralis minor, using fewer instruments. Residents improved with training, without reaching expert levels, and showed deterioration 12–18 months later. Individual procedure scores mirrored these results. Non-surgeons differed substantially.ConclusionsHand motion entropy and timing metrics discriminate levels of surgical skill and training, and these findings are congruent with individual procedure score evaluations. These measures can be collected using consumer-level cameras and analyzed automatically with free software. Hand motion with video timing data may have widespread application to evaluate resident performance and can contribute to the range of evaluation and testing modalities available to educators, training course designers and surgical quality assurance programs.