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AIM: The optimal management of patients with clinical complete response after neoadjuvant treatment for rectal cancer is controversial. The aim of this study is to compare the morbidity between patients with locally advanced rectal cancer who have had a pathological complete response (pCR) or not after neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME). The study hypothesis was that pCR may impact the surgical complication rate. METHOD: A retrospective cohort study was conducted of a prospectively maintained database in Australia and New Zealand, the Binational Colorectal Cancer Audit, that identified patients with locally advanced rectal cancer (<15 cm from anal verge) from 1 January 2007 to 31 December 2019. Patients were included if they had locally advanced rectal cancer and had undergone NCRT and proceeded to surgical resection. RESULTS: There were 4584 patients who satisfied the inclusion criteria, 65% being male. The mean age was 63 years and 11% had a pCR (ypT0N0). TME with anastomosis was performed in 67.8% of patients, and the majority of the cohort received long-course radiotherapy (81.7%). Both major and minor complications were higher in the TME without anastomosis group (17.3% vs. 14.7% and 30.6% vs. 20.8%, respectively), and the 30-day mortality was 1.31%. In the TME with anastomosis group, pCR did not contribute to higher rates of surgical complications, but male gender (p < 0.0012), age (p < 0.0001), preoperative N stage (p = 0.0092) and American Society of Anesthesologists (ASA) score ≥3 (p < 0.0002) did. In addition, pCR had no significant effect (p = 0.44) but male gender (p = 0.0047) and interval to surgery (p = 0.015) contributed to higher rates of anastomotic leak. In the TME without anastomosis cohort, the only variable that contributed to higher rates of complications was ASA score ≥3 (p = 0.033). CONCLUSION: Patients undergoing TME dissection for rectal cancer following NCRT showed no difference in complications whether they had achieved pCR or not.
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Terapia Neoadjuvante , Complicações Pós-Operatórias , Protectomia , Neoplasias Retais , Humanos , Neoplasias Retais/patologia , Neoplasias Retais/cirurgia , Neoplasias Retais/terapia , Masculino , Feminino , Pessoa de Meia-Idade , Terapia Neoadjuvante/estatística & dados numéricos , Estudos Retrospectivos , Idoso , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Protectomia/efeitos adversos , Austrália/epidemiologia , Nova Zelândia/epidemiologia , Resultado do Tratamento , Anastomose Cirúrgica/efeitos adversos , Reto/cirurgia , Quimiorradioterapia Adjuvante/estatística & dados numéricosRESUMO
PURPOSE: Surgical approach to rectal cancer has evolved in recent decades, with introduction of minimally invasive surgery (MIS) techniques and local excision. Since implementation might differ internationally, this study is aimed at evaluating trends in surgical approach to rectal cancer across different countries over the last 10 years and to gain insight into patient, tumour and treatment characteristics. METHODS: Pseudo-anonymised data of patients undergoing resection for rectal cancer between 2010 and 2019 were extracted from clinical audits in the Netherlands (NL), Sweden (SE), England-Wales (EW) and Australia-New Zealand (AZ). RESULTS: Ninety-nine thousand five hundred ninety-seven patients were included (38,413 open, 55,155 MIS and 5416 local excision). An overall increase in MIS was observed from 29.9% in 2010 to 72.1% in 2019, with decreasing conversion rates (17.5-9.0%). The MIS proportion was highly variable between countries in the period 2010-2014 (54.4% NL, 45.3% EW, 39.8% AZ, 14.1% SE, P < 0.001), but variation reduced over time (2015-2019 78.8% NL, 66.3% EW, 64.3% AZ, 53.2% SE, P < 0.001). The proportion of local excision for the two periods was highly variable between countries: 4.7% and 11.8% in NL, 3.9% and 7.4% in EW, 4.7% and 4.6% in AZ, 6.0% and 2.9% in SE. CONCLUSIONS: Application and speed of implementation of MIS were highly variable between countries, but each registry demonstrated a significant increase over time. Local excision revealed inconsistent trends over time.
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Protectomia , Neoplasias Retais , Humanos , Neoplasias Retais/cirurgia , Austrália/epidemiologia , Inglaterra , Sistema de RegistrosRESUMO
IMPORTANCE: The development of colorectal cancer outcome registries internationally has been organic, with differing datasets, data definitions and infrastructure across registries which has limited data pooling and international comparison. Currently there is no comprehensive data dictionary identified as a standard. This study is part of an international collaboration that aims to identify areas of data capture and usage which may be optimised to improve understanding of colorectal cancer outcomes. OBJECTIVE: This study aimed to compare and identify commonalities and areas of difference across major colorectal cancer registries. We sought to establish datasets comprising of mutually collected common fields, and a combined comprehensive dataset of all collected fields across major registries to aid in establishing a future colorectal cancer registry database standard. DESIGN AND METHODS: This mixed qualitative and quantitative study compared data dictionaries from three major colorectal cancer outcome registries: Bowel Cancer Outcomes Registry (BCOR) (Australia and New Zealand), National Bowel Cancer Audit (NBOCA) (United Kingdom) and Dutch ColoRectal Audit (DCRA) (Netherlands). Registries were compared and analysed thematically, and a common dataset and combined comprehensive dataset were developed. These generated datasets were compared to data dictionaries from Sweden (SCRCR), Denmark (DCCG), Argentina (BNCCR-A) and the USA (NAACCR and ACS NSQIP). Fields were assessed against prominent quality indicator metrics from the literature and current case-use. RESULTS: We developed a combined comprehensive dataset of 225 fields under seven domains: demographic, pre-operative, operative, post-operative, pathology, neoadjuvant therapy, adjuvant therapy, and follow up/recurrence. A common dataset was developed comprising 38 overlapping fields, showing a low degree of mutually collected data, especially in preoperative, post operative and adjuvant therapy domains. The BNCCR-A, SCRCR and DCCG databases all contained a high percentage of common dataset fields. Fields were poorly comparable when viewed form current quality indicator metrics. CONCLUSION: This study mapped data dictionaries of prominent colorectal cancer registries and highlighted areas of commonality and difference The developed common field dataset provides a foundation for registries to benchmark themselves and work towards harmonisation of data dictionaries. This has the potential to enable meaningful large-scale international outcomes research.
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Neoplasias Colorretais , Humanos , Sistema de Registros , Coleta de Dados , Países Baixos , Reino Unido , Neoplasias Colorretais/terapia , Neoplasias Colorretais/cirurgiaRESUMO
BACKGROUND: Surgeons vary in their approach to preventing pain post rubber band ligation (RBL) of haemorrhoids, with pudendal nerve blocks (PNB) being one analgesic strategy. No data exists on how commonly PNBs are used in RBL in Australia, and whether use varies by year and patient and hospital characteristics. METHODS: Aggregate data from the National Hospital Morbidity Database was obtained for all admissions for RBL in Australia from 2012 to 2021, with and without a PNB, overall and in relation to sex, age group, hospital remoteness, hospital sector, and year of procedure. Adjusted relative risks (adj. RR) of PNB were estimated using Poisson regression, mutually adjusting for all variables. RESULTS: Of the 346 542 admissions for RBL, 14013 (4.04%) involved a PNB. The proportion of patients receiving a PNB increased between 2012-2013 and 2020-2021, from 1.62% to 6.63% (adj. RR 3.99, CI 3.64-4.36). Patients most likely to receive a PNB were female (adj. RR 1.10; CI 1.07-1.14) aged 25-34 years (adj. RR 1.13; CI 1.01-1.26); in major-city (adj. RR 1.25 CI 1.20-1.30) and private hospitals (adj. RR 3.28 CI 3.13-3.45). CONCLUSION: This is the first published analysis of the use of PNB in RBL. Pudendal nerve block use has increased over time, with substantial variation in practice. Blocks were more than three times as likely to be used in private compared to public hospitals. If evidence supporting PNB use is established, equitable access to the procedure should be pursued.
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Hemorroidas , Bloqueio Nervoso , Nervo Pudendo , Humanos , Feminino , Bloqueio Nervoso/métodos , Masculino , Austrália/epidemiologia , Adulto , Hemorroidas/cirurgia , Ligadura/métodos , Estudos Transversais , Pessoa de Meia-Idade , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/epidemiologia , Idoso , Adulto JovemRESUMO
Importance: Postoperative urinary retention (POUR) is a well-recognized complication of inguinal hernia repair (IHR). A variable incidence of POUR has previously been reported in this context, and contradictory evidence surrounds potential risk factors. Objective: To ascertain the incidence of, explore risk factors for, and determine the health service outcomes of POUR following elective IHR. Design, Setting, and Participants: The Retention of Urine After Inguinal Hernia Elective Repair (RETAINER I) study, an international, prospective cohort study, recruited participants between March 1 and October 31, 2021. This study was conducted across 209 centers in 32 countries in a consecutive sample of adult patients undergoing elective IHR. Exposure: Open or minimally invasive IHR by any surgical technique, under local, neuraxial regional, or general anesthesia. Main Outcomes and Measures: The primary outcome was the incidence of POUR following elective IHR. Secondary outcomes were perioperative risk factors, management, clinical consequences, and health service outcomes of POUR. A preoperative International Prostate Symptom Score was measured in male patients. Results: In total, 4151 patients (3882 male and 269 female; median [IQR] age, 56 [43-68] years) were studied. Inguinal hernia repair was commenced via an open surgical approach in 82.2% of patients (n = 3414) and minimally invasive surgery in 17.8% (n = 737). The primary form of anesthesia was general in 40.9% of patients (n = 1696), neuraxial regional in 45.8% (n = 1902), and local in 10.7% (n = 446). Postoperative urinary retention occurred in 5.8% of male patients (n = 224), 2.97% of female patients (n = 8), and 9.5% (119 of 1252) of male patients aged 65 years or older. Risk factors for POUR after adjusted analyses included increasing age, anticholinergic medication, history of urinary retention, constipation, out-of-hours surgery, involvement of urinary bladder within the hernia, temporary intraoperative urethral catheterization, and increasing operative duration. Postoperative urinary retention was the primary reason for 27.8% of unplanned day-case surgery admissions (n = 74) and 51.8% of 30-day readmissions (n = 72). Conclusions: The findings of this cohort study suggest that 1 in 17 male patients, 1 in 11 male patients aged 65 years or older, and 1 in 34 female patients may develop POUR following IHR. These findings could inform preoperative patient counseling. In addition, awareness of modifiable risk factors may help to identify patients at increased risk of POUR who may benefit from perioperative risk mitigation strategies.
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Hérnia Inguinal , Laparoscopia , Retenção Urinária , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Retenção Urinária/epidemiologia , Retenção Urinária/etiologia , Retenção Urinária/cirurgia , Hérnia Inguinal/cirurgia , Hérnia Inguinal/complicações , Estudos de Coortes , Incidência , Estudos Prospectivos , Estudos Retrospectivos , Herniorrafia/efeitos adversos , Herniorrafia/métodos , Laparoscopia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Fatores de Risco , Anestesia GeralRESUMO
INTRODUCTION: Rubber band ligation ('banding') is a common approach for the management of symptomatic haemorrhoids. However, up to 90% of patients experience postprocedural pain, and there is no consensus regarding the optimal analgesic strategy. In practice, patients may receive submucosal local anaesthetic, pudendal nerve block or routine periprocedural analgesia. The aim of this study is to compare the efficacy of submucosal local anaesthetic, pudendal nerve block and routine analgesia for postprocedural pain in patients undergoing haemorrhoid banding. METHODS AND ANALYSIS: This is a multicentre, prospective, three-arm, double-blind randomised controlled trial of adults booked for haemorrhoid banding. Participants will be randomised to one of three groups in a 1:1:1 ratio: (1)submucosal bupivacaine injection; (2) pudendal nerve ropivacaine injection and (3) no local anaesthetic. The primary outcome is patient reported postprocedural pain (scored 0-10) from 30 min to 2 weeks. Secondary outcomes include postprocedural analgesia use, time to discharge, patient satisfaction, time to return to work and complications. A sample size of 120 patients is required to achieve statistical significance. ETHICS AND DISSEMINATION: This study received Human Research Ethics Approval from the Austin Health Human Research Ethics Committee (March 2022). Trial results will be submitted to a peer-reviewed journal, and presented at academic meetings. A summary of the trial results will be made available to study participants on request. TRIAL REGISTRATION NUMBER: ACTRN12622000006741p.
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Hemorroidas , Adulto , Humanos , Anestesia Local/métodos , Anestésicos Locais , Método Duplo-Cego , Hemorroidas/cirurgia , Estudos Multicêntricos como Assunto , Dor , Dor Pós-Operatória/prevenção & controle , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Lateral pelvic lymph node dissection (LPLND) in rectal cancer has gained increasing traction worldwide. Robotic LPLND is an emerging technique. Utilising the IDEAL (idea, development, exploration, assessment and long-term follow-up) framework for surgical innovation, robotic LPLND is currently at the IDEAL 2A stage (development) mainly limited to case reports, case series and videos. A systematic literature review was performed for videographic robotic LPLND. Pubmed, Ovid and Web of Science were searched with a predefined search strategy. The LapVEGAS score for peer review of video surgery was adapted for the robotic approach (RoVEGAS) and applied to measure video quality. Two reviewers independently reviewed videos and consensus reached on technical steps and learning points. Data are presented as a narrative synthesis of results. The IDEAL 2A framework was applied to videos to assess their content at the present stage of innovation. A total of 83 abstracts were identified. In accordance with the PRISMA statement, nine videos were analysed. Adherence to the complete IDEAL 2a framework was low. All videos demonstrated LPLND; however, reporting of clinical outcomes was heterogeneous and completed in six of nine videos. Histopathology was reported in six videos, with other outcomes variably reported. No videos presented patient-reported outcome measures. Two videos reported presence or absence of recurrence on follow-up. Video articles provide a valuable educational resource in dissemination and adoption of robotic techniques. Standardisation of reporting objectives are needed. Complete reporting of pathology and oncologic outcomes is required in videographic procedural-based publications to meet the IDEAL 2A framework criteria.
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Laparoscopia , Neoplasias Retais , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Laparoscopia/métodos , Excisão de Linfonodo/métodos , Neoplasias Retais/cirurgia , Neoplasias Retais/patologiaRESUMO
PURPOSE: Metabolomic analysis in colorectal cancer (CRC) is an emerging research area with both prognostic and therapeutic targeting potential. We aimed to identify metabolomic pathway activity prognostic for CRC recurrence and overall survival and cross-reference such metabolomic data with prognostic genomic single-nucleotide polymorphisms (SNPs). METHODS: A systematic search of PubMed, Embase and Cochrane Library was performed for studies reporting prognostic metabolomic pathway activity in CRC in keeping with PRISMA guidelines. The QUADOMICS tool was used to assess study quality. MetaboAnalyst software (version4.0) was used to map metabolites that were associated with recurrence and survival in CRC to recognise metabolic pathways and identify genomic SNPs associated with CRC prognosis, referencing the following databases: Human Metabolome Database (HMDB), the Small Molecule Pathway Database (SMPDB), PubChem and Kyoto Encyclopaedia of Genes and Genomes (KEGG) Pathway Database. RESULTS: Nine studies met the inclusion criteria, reporting on 1117 patients. Increased metabolic activity in the urea cycle (p = 0.002, FDR = 0.198), ammonia recycling (p = 0.004, FDR = 0.359) and glycine and serine metabolism (p = 0.004, FDR = 0.374) was prognostic of CRC recurrence. Increased activity in aspartate metabolism (p < 0.001, FDR = 0.079) and ammonia recycling (p = 0.004, FDR = 0.345) was prognostic of survival. Eight resulting SNPs were prognostic for CRC recurrence (rs2194980, rs1392880, rs2567397, rs715, rs169712, rs2300701, rs313408, rs7018169) and three for survival (rs2194980, rs169712, rs12106698) of which two overlapped with recurrence (rs2194980, rs169712). CONCLUSIONS: With a caveat on study heterogeneity, specific metabolites and metabolic pathway activity appear evident in the setting of poor prognostic colorectal cancers and such metabolic signatures are associated with specific genomic SNPs.
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Neoplasias Colorretais , Polimorfismo de Nucleotídeo Único , Humanos , Amônia , Neoplasias Colorretais/tratamento farmacológico , Genômica , Metabolômica/métodos , PrognósticoRESUMO
Robotic surgical training is undergoing a period of transition now that new robotic operating platforms are entering clinical practice. As this occurs, training will need to be adapted to include strategies to train across various consoles. These new consoles differ in multiple ways, with some new vendors using flat screen open source 3D enhanced vision with glasses and differences in design will require surgeons to learn new skills. This process has parallels with aviation credentialling across different aircraft described as type rating. This study was designed to test the hypothesis that technical robotic console operating skills are transferrable across different robotic operating platforms. Ten participants sequentially completed four Mimic®(Surgical Science) simulation exercises on two different robotic operating platforms (DaVinci®, Intuitive Surgical and HUGO™ RAS, Medtronic). Ethical approval and informed consent were obtained for this study. Groups were balanced for key demographics including previous robotic simulator experience. Data for simulation metrics and time to proficiency were collected for each attempt at the simulated exercise and analysed. Qualitative feedback on multi-platform learning was sought via unstructured interviews and a questionnaire. Participants were divided into two groups of 5. Group 1 completed the simulation exercises on console A first then repeated these exercises on console B. Group 2 completed the simulated exercises on console B first then repeated these exercises on console A. Group 1 candidates adapted quicker to the second console and Group 2 candidates reached proficiency faster on the first console. Participants were slower on the second attempt of the final exercise regardless of their allocated group. Quality and efficiency metrics and risk and safety metrics were equivalent across consoles. The data from this investigation suggests that console operating skills are transferrable across different platforms. Overall risk and safety metrics are within acceptable limits regardless of the order of progression of console indicating that training can safely occur across multiple consoles contemporaneously. This data has implications for the design of training and certification as new platforms progress to market and supports a proficiency-based approach.
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Procedimentos Cirúrgicos Robóticos , Robótica , Treinamento por Simulação , Cirurgiões , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Estudos Cross-Over , Robótica/educação , Simulação por Computador , Cirurgiões/educação , Competência ClínicaRESUMO
Objectives: Small bowel adenocarcinoma (SBA) with peritoneal metastasis (PM) is rare and despite treatment with systemic chemotherapy, the prognosis is poor. However, there is emerging evidence that cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) may offer a survival benefit over systemic therapy alone. This systematic review will assess the effectiveness of CRS-HIPEC for SBA-PM. Content: Three databases were searched from inception to 11/10/21. Clinical outcomes were extracted and analysed. Summary: A total of 164 cases of SBA-PM undergoing CRS-HIPEC were identified in 12 studies. The majority of patients had neoadjuvant chemotherapy (87/164, 53%) and complete cytoreduction (143/164, 87%) prior to HIPEC. The median overall survival was 9-32 months and 5-year survival ranged from 25 to 40%. Clavien-Dindo grade III/IV morbidity ranged between 19.1 and 50%, while overall mortality was low with only 3 treatment-related deaths. Outlook: CRS-HIPEC has the potential to improve the overall survival in a highly selected group of SBA-PM patients, with 5-year survival rates comparable to those reported in colorectal peritoneal metastases. However, the expected survival benefits need to be balanced against the intrinsic risk of morbidity and mortality associated with the procedure. Further multicentre studies are required to assess the safety and feasibility of CRS-HIPEC in SBA-PM to guide best practice management for this rare disease.
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BACKGROUND: The role of en bloc vascular resection and reconstruction (EVRR) is controversial in colorectal adenocarcinoma (CRC), but well-established in retroperitoneal sarcoma (RPS). Sparse data exists regarding these complex procedures. METHODS: Patients undergoing curative intent EVRR for advanced CRC and RPS between 2014 and 2021 at a tertiary centre were included. Morbidity, margins, recurrence, and survival were evaluated. RESULTS: 24 patients underwent EVRR with 48 reconstructions (11 CRC and 13 RPS). For CRC, 100% of patients underwent Iliac system reconstructions. For RPS, inferior vena cava reconstructions were the most common (69.2%). There were 2 arterial and 1 venous graft thromboses. Primary graft patency was 89.4% arterial and 93.1% venous, while secondary patency was 100% arterial and 96.5% venous at last follow up. 1 venous and 1 arterial graft required reoperation for bleeding. There were no compromised limbs. Major complications occurred in 6 patients (25.0%) with no observed difference between CRC and RPS (OR 0.43 95%CI[0.60,3.19], P = 0.41). R1 margins occurred 1 CRC (90.9%) and 3 RPS (76.9%), with no R2 resections. All vascular resection margins were clear. There were 6 CRC (50%) and 4 RPS (33.3%) recurrences. Median recurrence time was 20.9 months for CRC and 'not yet reached' for RPS. Median follow-up was 19.4 months for CRC and 21.4 months for RPS. CONCLUSION: EVRR for locally advanced CRC or RPS is safe and achieves favorable R0 resection rates. CRC patients with major vascular invasion can still be considered for curative intent surgery. Larger cohorts with longer follow up are needed to assess oncologic outcomes.
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Adenocarcinoma , Neoplasias Colorretais , Neoplasias Retroperitoneais , Sarcoma , Neoplasias de Tecidos Moles , Humanos , Estudos Retrospectivos , Margens de Excisão , Centros de Atenção Terciária , Resultado do Tratamento , Neoplasias Retroperitoneais/patologia , Sarcoma/patologia , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/patologia , Adenocarcinoma/cirurgia , Recidiva Local de Neoplasia/cirurgiaAssuntos
Neoplasias Retais , Humanos , Excisão de Linfonodo , Linfonodos , Pelve , Neoplasias Retais/cirurgiaRESUMO
Our article describes the anatomy, technical steps, common pitfalls, and our recommendations for performing a successful robotic lateral pelvic side wall dissection for rectal cancer. This is supplemented with videos and an image to clearly demonstrate our technique.
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Laparoscopia , Neoplasias Retais , Procedimentos Cirúrgicos Robóticos , Robótica , Dissecação , Humanos , Laparoscopia/métodos , Excisão de Linfonodo/métodos , Neoplasias Retais/cirurgia , Procedimentos Cirúrgicos Robóticos/métodosRESUMO
BACKGROUND: Robotic surgery is well established across multiple surgical specialities in the United Kingdom (UK) and Republic of Ireland (ROI). We aimed to elucidate current surgical trainee experience of and attitudes to robotic surgery in a surgical training programme across the UK and ROI to determine the future role of robotic surgery in international surgical training programmes. Methods: A pan-specialty trainee cross-sectional study was performed on behalf of the Association of Surgeons in Training (ASiT) using mixed-methodology. Round 1: a digital questionnaire was disseminated to all ASiT members. Round 2: 'live-polling' was performed prior to and following the Robotic Surgery plenary session convened at the ASiT 2020 International Conference (Birmingham). Data analysis was performed using a combination of quantitative and qualitative methods. RESULTS: Three hundred and four responses were analysed (n = 244 digital questionnaire, n = 60 live-polling). Overall, 73.8% (n = 180) of trainees would value greater access to robotic surgery training. 73.4% (n = 179) believed that robotic surgery was important for the future of their desired specialty and 77.2% (n = 156) believed it should be incorporated into formal surgical training. Qualitative analysis identified that trainees believe that robotic training should have a formal role in surgical training. Perceived disadvantages of robotic surgery experience in surgical training included expense and the current impact of consultant robotic learning curves on training. CONCLUSION: Current surgical trainees desire greater access to robotic surgery in surgical training. Robotic surgery is developing an increasing role in current surgical practice and it is important that it is introduced in a timely, evidence-based fashion to surgical trainees at an appropriate stage of training.
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Procedimentos Cirúrgicos Robóticos , Cirurgiões , Atitude , Competência Clínica , Estudos Transversais , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Cirurgiões/educação , Inquéritos e QuestionáriosRESUMO
PURPOSE: Post-operative urinary retention (POUR) is a well-recognised complication of inguinal hernia repair (IHR). The magnitude of the problem is unclear, and contradictory evidence surrounds postulated risk factors. POUR risks patient distress, catheter-complications and a financial and logistical burden to services. Separately, in the field of IHR, there has been a lack of research into patients' perceptions of surgical 'success'. Our aim is to perform a two-phase, multi-centre prospective study to:Assess the rate, risk factors and impact related to POUR post IH repair.Develop and validate a patient reported outcome measure (PROM) for inguinal hernia repair. METHODS: RETAINER I: We propose a 24-week prospective study with voluntary international participation in 4 week blocks. All patients undergoing elective IH repair (minimally-invasive/open) will be eligible. Standardised data collection will include patient and perioperative factors. Primary outcome will be development of POUR, defined as the need for insertion of a urinary catheter as determined by the treating clinician. Secondary outcomes will be identification of factors predisposing to POUR and the impact of POUR.RETAINER II: A patient reported outcome measure will be developed using representative patient focus groups for item generation, from which an initial questionnaire will be developed and piloted. Validity, reliability, sensitivity and reproducibility will be assessed using the QQ-10 and standard psychometric methodology. CONCLUSIONS: Using an international multicentre collaborative approach will produce the necessary volume of patients, whilst capturing inter-centre variability, to accurately reflect POUR rates and allow analysis of risk factors. This patient pool will provide an excellent opportunity to develop a PROM using appropriate qualitative methodology. HIGHLIGHTS RETAINER I & II PROTOCOLS: RETAINER (RETention of urine After INguinal hernia Elective Repair) I is a prospective, multicentre, international observational study.RETAINER I aims to explore the incidence of and risk factors for urinary retention following elective inguinal hernia repair.Urinary retention following inguinal hernia repair has a marked impact on patients and creates a significant financial and logistical burden for hospital services.RETAINER II is a prospective, qualitative study, recruiting patients to guide the creation of a patient-reported outcome measure (PROM) for elective inguinal hernia repair.