A Delphi consensus statement for digital surgery.

The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term 'digital surgery'. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice. 38 international experts, across the fields of surgery, AI, industry, law, ethics and policy, participated in a four-round Delphi exercise. Issues were generated by an expert panel and public panel through a scoping questionnaire around key themes identified from the literature and voted upon in two subsequent questionnaire rounds. Consensus was defined if >70% of the panel deemed the statement important and <30% unimportant. A final online meeting was held to discuss consensus statements. The definition of digital surgery as the use of technology for the enhancement of preoperative planning, surgical performance, therapeutic support, or training, to improve outcomes and reduce harm achieved 100% consensus agreement. We highlight key ethical issues concerning data, privacy, confidentiality and public trust, consent, law, litigation and liability, and commercial partnerships within digital surgery and identify barriers and research goals for future practice. Developers and users of digital surgery must not only have an awareness of the ethical issues surrounding digital applications in healthcare, but also the ethical considerations unique to digital surgery. Future research into these issues must involve all digital surgery stakeholders including patients.

Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England.

OBJECTIVE: To examine the impact of The National Training Program for Lapco on the rate of laparoscopic surgery and clinical outcomes of cases performed by Lapco surgeons after completion of training. SUMMARY OF BACKGROUND DATA: Lapco provided competency-based supervised clinical training for specialist colorectal surgeons in England. METHODS: We compared the rate of laparoscopic surgery, mortality, and morbidity for colorectal cancer resections by Lapco delegates and non-Lapco surgeons in 3-year periods preceding and following Lapco using difference in differences analysis. The changes in the rate of post-Lapco laparoscopic surgery with the Lapco sign-off competency assessment and in-training global assessment scores were examined using risk-adjusted cumulative sum to determine their predictive clinical validity with predefined competent scores of 3 and 5 respectively. RESULTS: One hundred eight Lapco delegates performed 4586 elective colo-rectal resections pre-Lapco and 5115 post-Lapco while non-Lapco surgeons performed 72,930 matched cases. Lapco delegates had a 37.8% increase in laparoscopic surgery which was greater than non-Lapco surgeons by 20.9% [95% confidence interval (CI), 18.5-23.3, P < 0.001) with a relative decrease in 30-day mortality by -1.6% (95% CI, -3.4 to -0.2, P = 0.039) and 90-day mortality by -2.3% (95% CI, -4.3 to -0.4, P = 0.018). The change point of risk-adjusted cumulative sum was 3.12 for competency assessment tool and 4.74 for global assessment score whereas laparoscopic rate increased from 44% to 66% and 40% to 56%, respectively. CONCLUSIONS: Lapco increased the rate of laparoscopic colorectal cancer surgery and reduced mortality and morbidity in England. In-training competency assessment tools predicted clinical performance after training.

Analysis of lesion localisation at colonoscopy: outcomes from a multi-centre U.K. study.

BACKGROUND: Colonoscopy is currently the gold standard for detection of colorectal lesions, but may be limited in anatomically localising lesions. This audit aimed to determine the accuracy of colonoscopy lesion localisation, any subsequent changes in surgical management and any potentially influencing factors. METHODS: Patients undergoing colonoscopy prior to elective curative surgery for colorectal lesion/s were included from 8 registered U.K. sites (2012-2014). Three sets of data were recorded: patient factors (age, sex, BMI, screener vs. symptomatic, previous abdominal surgery); colonoscopy factors (caecal intubation, scope guide used, colonoscopist accreditation) and imaging modality. Lesion localisation was standardised with intra-operative location taken as the gold standard. Changes to surgical management were recorded. RESULTS: 364 cases were included; majority of lesions were colonic, solitary, malignant and in symptomatic referrals. 82% patients had their lesion/s correctly located at colonoscopy. Pre-operative CT visualised lesion/s in only 73% of cases with a reduction in screening patients (64 vs. 77%; p = 0.008). 5.2% incorrectly located cases at colonoscopy underwent altered surgical management, including conversion to open. Univariate analysis found colonoscopy accreditation, scope guide use, incomplete colonoscopy and previous abdominal surgery significantly influenced lesion localisation. On multi-variate analysis, caecal intubation and scope guide use remained significant (HR 0.35, 0.20-0.60 95% CI and 0.47; 0.25-0.88, respectively). CONCLUSION: Lesion localisation at colonoscopy is incorrect in 18% of cases leading to potentially significant surgical management alterations. As part of accreditation, colonoscopists need lesion localisation training and awareness of when inaccuracies can occur.

Bovine immunoglobulin/protein isolate binds pro-inflammatory bacterial compounds and prevents immune activation in an intestinal co-culture model.

Intestinal barrier dysfunction is associated with chronic gastrointestinal tract inflammation and diseases such as IBD and IBS. Serum-derived bovine immunoglobulin/protein isolate (SBI) is a specially formulated protein preparation (>90%) for oral administration. The composition of SBI is greater than 60% immunoglobulin including contributions from IgG, IgA, and IgM. Immunoglobulin within the lumen of the gut has been recognized to have anti-inflammatory properties and is involved in maintaining gut homeostasis. The binding of common intestinal antigens (LPS and Lipid A) and the ligand Pam3CSK4, by IgG, IgA, and IgM in SBI was shown using a modified ELISA technique. Each of these antigens stimulated IL-8 and TNF-α cytokine production by THP-1 monocytes. Immune exclusion occurred as SBI (≤50 mg/mL) bound free antigen in a dose dependent manner that inhibited cytokine production by THP-1 monocytes in response to 10 ng/mL LPS or 200 ng/mL Lipid A. Conversely, Pam3CSK4 stimulation of THP-1 monocytes was unaffected by SBI/antigen binding. A co-culture model of the intestinal epithelium consisted of a C2BBe1 monolayer separating an apical compartment from a basal compartment containing THP-1 monocytes. The C2BBe1 monolayer was permeabilized with dimethyl palmitoyl ammonio propanesulfonate (PPS) to simulate a damaged epithelial barrier. Results indicate that Pam3CSK4 was able to translocate across the PPS-damaged C2BBe1 monolayer. However, binding of Pam3CSK4 by immunoglobulins in SBI prevented Pam3CSK4 translocation across the damaged C2BBe1 barrier. These results demonstrated steric exclusion of antigen by SBI which prevented apical to basal translocation of antigen due to changes in the physical properties of Pam3CSK4, most likely as a result of immunoglobulin binding. This study demonstrates that immunoglobulins in SBI can reduce antigen-associated inflammation through immune and steric exclusion mechanisms and furthers the mechanistic understanding of how SBI might improve immune status and reduce inflammation in various intestinal disease states.

Orphan receptor IL-17RD regulates Toll-like receptor signalling via SEFIR/TIR interactions.

Receptor families of the innate immune response engage in 'cross-talk' to tailor optimal immune responses against invading pathogens. However, these responses are subject to multiple levels of regulation to keep in check aberrant inflammatory signals. Here, we describe a role for the orphan receptor interleukin-17 receptor D (IL-17RD) in negatively regulating Toll-like receptor (TLR)-induced responses. Deficiency of IL-17RD expression in cells leads to enhanced pro-inflammatory signalling and gene expression in response to TLR stimulation, and Il17rd(-/-) mice are more susceptible to TLR-induced septic shock. We demonstrate that the intracellular Sef/IL-17R (SEFIR) domain of IL-17RD targets TIR adaptor proteins to inhibit TLR downstream signalling thus revealing a paradigm involving cross-regulation of members of the IL-17R and TLR families.

Use of fibrin glue for fixation of mesh and approximation of Peritoneum in Transabdominal Preperitoneal (TAPP) inguinal hernia repair: technical feasibility and early surgical outcomes.

BACKGROUND: It is a common practice to secure both mesh and peritoneum using tacks when performing a transabdominal preperitoneal (TAPP) inguinal hernia repair. The use of tacks to secure the mesh is well documented and has been associated with postoperative chronic pain. Recently, fibrin glue has been used to secure the mesh in these repairs but not used to reapproximate the incised peritoneum. This study assessed the technical feasibility of using fibrin glue for fixation of both mesh and peritoneum. PATIENTS AND METHODS: A total of 33 TAPP hernia repairs were carried out in 27 consecutive patients. In all the patients, both mesh and peritoneum were secured with fibrin glue (20 primary inguinal hernia repairs, 5 bilateral hernia repairs, 1 recurrent inguinal hernia, and 1 recurrent bilateral hernia repair). RESULTS: Patients were followed up at an outpatient clinic between the second and third week after surgery. Six patients were followed up through telephone. Patients were questioned on the following factors: residual postoperative pain (groin and port sites), unplanned GP or hospital visits, employment status and number of days between their surgery and return to both work and normal activities, and recurrence. No patients had residual groin or port site pain at a median of 21 days after surgery. No patient required an unplanned follow-up appointment with their GP. One patient (recurrent repair) developed a seroma postoperatively. Median time to normal activities was 10 days (range, 3 to 21 d). CONCLUSIONS: Total glue fixation of mesh and peritoneum is technically feasible and early results show low rates of postoperative complications and pain. Randomized studies are needed to confirm this.

Basic laparoscopic skills training using fresh frozen cadaver: a randomized controlled trial.

BACKGROUND: The purpose of this study was to determine whether training on fresh cadavers improves the laparoscopic skills performance of novices. METHODS: Junior surgical trainees, novices (<3 laparoscopic procedure performed) in laparoscopic surgery, were randomized into control (group A) and practice groups (group B). Group B performed 10 repetitions of a set of structured laparoscopic tasks on fresh frozen cadavers (FFCs) improvised from fundamentals of laparoscopic skills technical curriculum. Performance on cadavers was scored using a validated, objective Global Operative Assessment of Laparoscopic Skills scale. The baseline technical ability of the 2 groups and any transfer of skills from FFCs was measured using a full procedural laparoscopic cholecystectomy task on a virtual reality simulator before and after practice on FFCs, respectively. Nonparametric tests were used for analysis of the results. RESULTS: Twenty candidates were randomized; 1 withdrew before the study commenced, and 19 were analyzed (group A, n = 9; group B; n = 10). Four of 5 tasks (nondominant to dominant hand transfer, simulated appendectomy, intracorporeal, and extracorporeal knot tying) on FFCs showed significant improvement on learning curve analysis. After training, significant improvement was shown for safety of cautery (P = .040) and the left arm path length (P = .047) on the virtual reality simulator by the practice group. CONCLUSIONS: Training on FFCs significantly improves basic laparoscopic skills and can improve full procedural performance.

Consensus views on implementation and measurement of enhanced recovery after surgery in England: Delphi study.

OBJECTIVE: The Department of Health's Enhanced Recovery Partnership Programme (ERPP) started a spread and adoption scheme of Enhanced Recovery After Surgery (ERAS) throughout England. In preparation for widespread adoption the ERPP wished to obtain expert consensus on appropriate outcome measures for ERAS, emerging techniques being widely adopted and proposed methods for the continued development and sustainability of ERAS in the National Health Service. The aim of this study was to interrogate expert opinion and define areas of consensus on these issues. DESIGN: A Delphi technique using three rounds of reiterative questionnaires was used to obtain consensus. PARTICIPANTS: Experts were chosen from teams with experience of delivering a successful ERAS programme across different surgical specialties and across various disciplines. SETTING: The first two rounds of the questionnaire were completed online and a final, third round was undertaken in a meeting using interactive voting. RESULTS: 86 experts took part in this study. Consensus statements agreed that patient experience data should be recorded, analysed and reviewed at regular ERAS meetings. Recent developments in regional analgesia, the increased use of intraoperative monitoring for fluid management and cardio-pulmonary exercise testing were the main emerging techniques identified. National standards for those outcome measures would be welcomed. To sustain success in ERAS, the experts highlighted clinical champions and the presence of a dedicated ERAS facilitator as essential elements. For future networking, a unanimous agreement was achieved on the formation a national network to facilitate spread and adoption of ERAS and to promote research and education across surgery. CONCLUSIONS: Consensus was achieved on regular measurement and review of patient experience in ERAS. Agreement was reached on the role of regional analgesia and the use of oesophageal Doppler for intraoperative goal-directed fluid therapy. In order to facilitate the further spread and adoption of best practices and to promote research and education, an ERAS-UK network was recommended.

Orphan receptor IL-17RD tunes IL-17A signalling and is required for neutrophilia.

Interleukin-17A, the prototypical member of the interleukin-17 cytokine family, coordinates local tissue inflammation by recruiting neutrophils to sites of infection. Dysregulation of interleukin-17 signalling has been linked to the pathogenesis of inflammatory diseases and autoimmunity. The interleukin-17 receptor family members (A-E) have a broad range of functional effects in immune signalling yet no known role has been described for the remaining orphan receptor, interleukin-17 receptor D, in regulating interleukin-17A-induced signalling pathways. Here we demonstrate that interleukin-17 receptor D can differentially regulate the various pathways employed by interleukin-17A. Neutrophil recruitment, in response to in vivo administration of interleukin-17A, is abolished in interleukin-17 receptor D-deficient mice, correlating with reduced interleukin-17A-induced activation of p38 mitogen-activated protein kinase and expression of the neutrophil chemokine MIP-2. In contrast, interleukin-17 receptor D deficiency results in enhanced interleukin-17A-induced activation of nuclear factor-kappa B and interleukin-6 and keratinocyte chemoattractant expression. Interleukin-17 receptor D disrupts the interaction of Act1 and TRAF6 causing differential regulation of nuclear factor-kappa B and p38 mitogen-activated protein kinase signalling pathways.

Comparison of fresh-frozen cadaver and high-fidelity virtual reality simulator as methods of laparoscopic training.

BACKGROUND: The aim of this study was to compare fresh-frozen cadavers (FFC) with a high-fidelity virtual reality simulator (VRS) as training tools in minimal access surgery for complex and relatively simple procedures. METHODS: A prospective comparative face validity study between FFC and VRS (LAP Mentor(™)) was performed. Surgeons were recruited to perform tasks on both FFC and VRS appropriately paired to their experience level. Group A (senior) performed a laparoscopic sigmoid colectomy, Group B (intermediate) performed a laparoscopic incisional hernia repair, and Group C (junior) performed basic laparoscopic tasks (BLT) (camera manipulation, hand-eye coordination, tissue dissection and hand-transferring skills). Each subject completed a 5-point Likert-type questionnaire rating the training modalities in nine domains. Data were analysed using nonparametric tests. RESULTS: Forty-five surgeons were recruited to participate (15 per skill group). Median scores for subjects in Group A were significantly higher for evaluation of FFC in all nine domains compared to VRS (p < 0.01). Group B scored FFC significantly better (p < 0.05) in all domains except task replication (p = 0.06). Group C scored FFC significantly better (p < 0.01) in eight domains but not on performance feedback (p = 0.09). When compared across groups, juniors accepted VRS as a training model more than did intermediate and senior groups on most domains (p < 0.01) except team work. CONCLUSIONS: Fresh-frozen cadaver is perceived as a significantly overall better model for laparoscopic training than the high-fidelity VRS by all training grades, irrespective of the complexity of the operative procedure performed. VRS is still useful when training junior trainees in BLT.

Construct validity of fresh frozen human cadaver as a training model in minimal access surgery.

BACKGROUND: The construct validity of fresh human cadaver as a training tool has not been established previously. The aims of this study were to investigate the construct validity of fresh frozen human cadaver as a method of training in minimal access surgery and determine if novices can be rapidly trained using this model to a safe level of performance. METHODS: Junior surgical trainees, novices (<3 laparoscopic procedure performed) in laparoscopic surgery, performed 10 repetitions of a set of structured laparoscopic tasks on fresh frozen cadavers. Expert laparoscopists (>100 laparoscopic procedures) performed 3 repetitions of identical tasks. Performances were scored using a validated, objective Global Operative Assessment of Laparoscopic Skills scale. Scores for 3 consecutive repetitions were compared between experts and novices to determine construct validity. Furthermore, to determine if the novices reached a safe level, a trimmed mean of the experts score was used to define a benchmark. Mann-Whitney Utest was used for construct validity analysis and 1-sample t test to compare performances of the novice group with the benchmark safe score. RESULTS: Ten novices and 2 experts were recruited. Four out of 5 tasks (nondominant to dominant hand transfer; simulated appendicectomy; intracorporeal and extracorporeal knot tying) showed construct validity. Novices' scores became comparable to benchmark scores between the eighth and tenth repetition. CONCLUSION: Minimal access surgical training using fresh frozen human cadavers appears to have construct validity. The laparoscopic skills of novices can be accelerated through to a safe level within 8 to 10 repetitions.

Cadaveric hands-on training for surgical specialties: is this back to the future for surgical skills development?

INTRODUCTION: Delivery of surgical care is linked intricately to technical proficiency. Recent legislative changes in the United Kingdom have facilitated the introduction of new teaching methods. This article is a review of our experience with a cadaver laboratory housed within a tertiary referral hospital and assesses the impact of such for the future delivery of surgical care in the United Kingdom. MATERIALS AND METHODS: We describe in this article the logistics of setting up and running a fresh frozen cadaver laboratory, the governance arrangements in place, the performance of the facility in the first 2 years, and the feedback from the participants. RESULTS: The center hosts approximately 60 courses per year across a range of surgical disciplines that have received excellent feedback. Support from the Trust Board, local charities, multidisciplinary faculty, and the industry underpinned by robust governance has resulted in a successful venture. CONCLUSIONS: Hands-on training is increasingly relevant in craft specialties. After the introduction of the European working time directive, there is clear evidence of reduction in time spent performing live surgical procedures by trainees. There has been an explosion in the introduction of new surgical technology and marked expansion in the instrumentation that accompanies such procedures. Greater scrutiny of surgical outcomes is now in the public domain. To embrace and maximize patient benefit successfully, it is mandatory that the surgeon of the future will require access to dedicated near patient surgical training in specific skills without jeopardizing patient care.

Analysis of laboratory-based laparoscopic colorectal surgery workshops within the English National Training Programme.

BACKGROUND: This study aimed to determine and compare the opinions of trainees and trainers attending courses using two simulation models (fresh frozen cadavers or anaesthetized pigs) and to assess trainees' degree of insight into both the difficulty of different procedures and their operative performance in the simulated environment. METHODS: Trainers and trainees attending the training courses completed questionnaires. Performance was evaluated using the Global Assessment Score (GAS). RESULTS: Data were collected over a 12-month period from 26 trainers and 77 trainees. The overall satisfaction was high after attendance at either course (4.50 vs. 4.49; p=0.83). When the opinions of the trainees and trainers in cadaveric and animal courses were compared, the findings rated the animal model as superior in terms of tissue quality (3.97 vs. 3.55; p=0.02), persistence of air leak (1.43 vs. 2.40; p<0.001), and lack of disturbance by odor (4.24 vs. 3.41; p<0.001). The cadaveric model provided more realistic simulation for port placement (4.02 vs. 3.11; p<0.001) and anatomy (4.25 vs. 3.00; p<0.001) and was perceived to be superior as a training model (4.53 vs. 3.61; p=0.001). The trainees demonstrated good insight into procedure difficulty and their operative performance. The trainees and trainers were shown to have a good concordance of scores. The trainees were more inclined to underrate and the peers to overrate their performance. CONCLUSIONS: Trainees appear to have a good insight into procedure difficulty and their ability. Both training models have advantages and disadvantages, but overall, the cadaveric model is perceived to have a higher fidelity and greater educational value.

Endoluminal insertion of colonic stents.

For patients with obstructing colonic tumours endoluminal stents provide an alternative to surgical decompression. Used either as permanent palliation, or as a bridge to surgery, colonic stents have been shown to be effective, safe, and cost effective.

Successful voiding after trial without catheter is not synonymous with recovery of bladder function after colorectal surgery.

PURPOSE: The need for monitoring postoperative urine output and the possibility of lower urinary tract dysfunction following colorectal surgery necessitates temporary urinary drainage. Current practice assumes recovery of lower urinary tract function to coincide with successful micturition after removal of urethral catheter. The aim of this study was to analyze the recovery of bladder function following colorectal surgery. METHODS: Patients undergoing colorectal operations underwent preoperative and postoperative uroflowmetry and residual urine estimation. All patients were catheterized suprapubically at surgery. Uroflowmetry and postvoid residual volumes were recorded postoperatively until recovery of bladder function was complete. RESULTS: Thirty consecutive patients underwent suprapubic catheterization, 25 of whom completed the study. Seventeen (68 percent) patients were able to pass urine within 72 hours of surgery. Recovery of lower urinary tract function was delayed in patients undergoing rectal vs. colonic resections (median, 6 vs. 3 days, P = 0.0015). Postvoid residual volumes greater than 200 ml were noted in three (20 percent) patients following rectal resections beyond the tenth postoperative day, with complete emptying achieved by six weeks. CONCLUSIONS: Apparent successful micturition following rectal resections does not always indicate recovery of bladder function. The use of suprapubic catheters, in addition to being safe and effective, allows assessment of residual volumes postoperatively and smoothes the path to full recovery of lower urinary tract function.

Preoperative intensive, community-based vs. traditional stoma education: a randomized, controlled trial.

PURPOSE: Conventional practice in colorectal surgery involves stoma education being imparted postoperatively. Proficiency in stoma management often delays patients' discharge following colorectal surgery. The aim of this randomized, controlled trial was to compare preoperative intensive, community-based stoma education with conventional postoperative stoma education after elective colorectal surgery. METHODS: Forty-two elective colorectal patients requiring a stoma were randomized into an intensive preoperative teaching (study) or postoperative (control) group. Intervention for the study group included two preoperative visits in the community during which patients were taught with audiovisual aids to use and change the stoma pouching system. Goal-directed postoperative stoma education was standardized for both groups. Outcomes measured included time to stoma proficiency, postoperative hospital stay, unplanned stoma-related interventions in the community within six weeks of discharge, and preoperative and postoperative hospital anxiety and depression scores. Cost-effectiveness of the intervention was also evaluated. RESULTS: All outcomes measured were improved in the study group, including time to stoma proficiency (5.5 vs. 9 days; P = 0.0005), hospital stay (8 vs. 10 days; P = 0.029), and unplanned stoma-related community interventions per patient (median 0 vs. 0.5; P = 0.0309). No adverse effects of the intervention were noted. The average cost saving per patient was pound 1,119 (dollar 2,104) for the study group compared with the control group. CONCLUSIONS: Stoma education is more effective if undertaken in the preoperative setting. It results in shorter times to stoma proficiency and earlier discharge from the hospital. It also reduces stoma-related interventions in the community and has no adverse effects on patient well-being.

Curative potential of multimodality therapy for locally recurrent rectal cancer.

OBJECTIVE: To assess the results of multimodality therapy for patients with recurrent rectal cancer and to analyze factors predictive of curative resection and prognostic for overall survival. SUMMARY BACKGROUND DATA: Locally recurrent rectal cancer is a difficult clinical problem, and radical treatment options with curative intent are not generally accepted. METHODS: A total of 394 patients underwent surgical exploration for recurrent rectal cancer. Ninety were found to have unresectable local or extrapelvic disease and 304 underwent resection of the recurrence. The latter patients were prospectively followed to determine long-term survival and factors influencing survival. RESULTS: Overall 5-year survival was 25%. Curative, negative resection margins were obtained in 45% of patients; in these patients a 5-year survival of 37% was achieved, compared to 16% (P <.001) in patients with either microscopic or gross residual disease. In a logistic regression analysis, initial surgery with end-colostomy and symptomatic pain (both univariate) and increasing number of sites of the recurrent tumor fixation in the pelvis (multivariate) were associated with palliative surgery. Overall survival was significantly decreased for symptomatic pain (P <.001) and more than one fixation (P =.029). Survival following extended resection of adjacent organs was not different from limited resection (28% vs. 21%, P =.11). Patient demographics and factors related to the initial rectal cancer did not affect outcome. Perioperative mortality was only 0.3%, but significant morbidity occurred in 26% of patients, with pelvic abscess being the most common complication. CONCLUSIONS: This study demonstrates that many patients with locally recurrent rectal cancer can be resected with negative margins. Long-term survival can be achieved, especially for patients with no symptoms and minimal fixation of the recurrence in the pelvis, provided no gross residual disease remains.