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1.
Ann Surg Oncol ; 31(6): 4005-4017, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38526832

RESUMO

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.


Assuntos
Fluordesoxiglucose F18 , Gastrectomia , Laparoscopia , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Compostos Radiofarmacêuticos , Neoplasias Gástricas , Neoplasias Gástricas/patologia , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/diagnóstico por imagem , Neoplasias Gástricas/economia , Humanos , Laparoscopia/economia , Laparoscopia/métodos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/economia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Estudos Prospectivos , Gastrectomia/economia , Fluordesoxiglucose F18/economia , Compostos Radiofarmacêuticos/economia , Análise Custo-Benefício , Seguimentos , Prognóstico , Custos e Análise de Custo , Masculino , Feminino
2.
Br J Surg ; 111(2)2024 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-38387083

RESUMO

BACKGROUND: This study evaluated the association of pathological tumour response (tumour regression grade, TRG) and a novel scoring system, combining both TRG and nodal status (TRG-ypN score; TRG1-ypN0, TRG>1-ypN0, TRG1-ypN+ and TRG>1-ypN+), with recurrence patterns and survival after multimodal treatment of oesophageal adenocarcinoma. METHODS: This Dutch nationwide cohort study included patients treated with neoadjuvant chemoradiotherapy followed by oesophagectomy for distal oesophageal or gastro-oesophageal junctional adenocarcinoma between 2007 and 2016. The primary endpoint was the association of Mandard score and TRG-ypN score with recurrence patterns (rate, location, and time to recurrence). The secondary endpoint was overall survival. RESULTS: Among 2746 inclusions, recurrence rates increased with higher Mandard scores (TRG1 30.6%, TRG2 44.9%, TRG3 52.9%, TRG4 61.4%, TRG5 58.2%; P < 0.001). Among patients with recurrent disease, the distribution (locoregional versus distant) was the same for the different TRG groups. Patients with TRG1 developed more brain recurrences (17.7 versus 9.8%; P = 0.001) and had a longer mean overall survival (44 versus 35 months; P < 0.001) than those with TRG>1. The TRG>1-ypN+ group had the highest recurrence rate (64.9%) and worst overall survival (mean 27 months). Compared with the TRG>1-ypN0 group, patients with TRG1-ypN+ had a higher risk of recurrence (51.9 versus 39.6%; P < 0.001) and worse mean overall survival (33 versus 41 months; P < 0.001). CONCLUSION: Improved tumour response to neoadjuvant therapy was associated with lower recurrence rates and higher overall survival rates. Among patients with recurrent disease, TRG1 was associated with a higher incidence of brain recurrence than TRG>1. Residual nodal disease influenced prognosis more negatively than residual disease at the primary tumour site.


Assuntos
Adenocarcinoma , Neoplasias Esofágicas , Humanos , Prognóstico , Estudos de Coortes , Intervalo Livre de Doença , Terapia Combinada
3.
Surg Innov ; : 15533506241244854, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38626174

RESUMO

INTRODUCTION: Determining limb length in gastric bypass procedures is a crucial step to ensure significant weight loss without risking malnutrition. This study investigated the effect of ex vivo training on the skills needed to determine limb lengths. MATERIALS AND METHODS: This was a single-center ex vivo training experiment in a teaching hospital in the Netherlands. We designed a training exercise with marked ropes in a laparoscopic trainer box. All ten surgical residents participated and practiced the skill of estimating limb length. Before and after the two-week period their results on a 150-centimeter limb length task were evaluated. RESULTS: Before training, 10 surgical residents estimated 150 centimeters of small bowel with an absolute deviation of 21% [range 9-30]. After the training experiment, the residents measured with 8% [2-20] deviation (P = .17). The 8 residents who trained sufficiently improved statistically significantly to an absolute deviation of 5% [2-17] (P = .012). Over 70% of the participants felt their skills had improved. CONCLUSIONS: With sufficient training, surgical residents' skills in measuring small bowel length improved when tested in an ex vivo model. Residents became more confident in their laparoscopic measurement skills. This ex vivo training model is a alternative and addition to on-site training.

4.
Ann Surg ; 277(4): 619-628, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35129488

RESUMO

OBJECTIVE: This study evaluated the nationwide trends in care and accompanied postoperative outcomes for patients with distal esophageal and gastro-esophageal junction cancer. SUMMARY OF BACKGROUND DATA: The introduction of transthoracic esophagectomy, minimally invasive surgery, and neo-adjuvant chemo(radio)therapy changed care for patients with esophageal cancer. METHODS: Patients after elective transthoracic and transhiatal esophagectomy for distal esophageal or gastroesophageal junction carcinoma in the Netherlands between 2007-2016 were included. The primary aim was to evaluate trends in both care and postoperative outcomes for the included patients. Additionally, postoperative outcomes after transthoracic and tran-shiatal esophagectomy were compared, stratified by time periods. RESULTS: Among 4712 patients included, 74% had distal esophageal tumors and 87% had adenocarcinomas. Between 2007 and 2016, the proportion of transthoracic esophagectomy increased from 41% to 81%, and neo-adjuvant treatment and minimally invasive esophagectomy increased from 31% to 96%, and from 7% to 80%, respectively. Over this 10-year period, postoperative outcomes improved: postoperative morbidity decreased from 66.6% to 61.8% ( P = 0.001), R0 resection rate increased from 90.0% to 96.5% (P <0.001), median lymph node harvest increased from 15 to 19 ( P <0.001), and median survival increased from 35 to 41 months ( P = 0.027). CONCLUSION: In this nationwide cohort, a transition towards more neo-adju-vant treatment, transthoracic esophagectomy and minimally invasive surgery was observed over a 10-year period, accompanied by decreased postoperative morbidity, improved surgical radicality and lymph node harvest, and improved survival.


Assuntos
Adenocarcinoma , Neoplasias Esofágicas , Neoplasias Gástricas , Humanos , Adenocarcinoma/cirurgia , Linfonodos/patologia , Junção Esofagogástrica/cirurgia , Junção Esofagogástrica/patologia , Excisão de Linfonodo , Neoplasias Esofágicas/cirurgia , Esofagectomia/efeitos adversos , Neoplasias Gástricas/cirurgia , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento
5.
Int J Colorectal Dis ; 38(1): 105, 2023 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-37074421

RESUMO

BACKGROUND: Laparoscopic surgery has become the golden standard for many procedures, requiring new skills and training methods. The aim of this review is to appraise literature on assessment methods for laparoscopic colorectal procedures and quantify these methods for implementation in surgical training. MATERIALS AND METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials databases were searched in October 2022 for studies reporting learning and assessment methods for laparoscopic colorectal surgery. Quality was scored using the Downs and Black checklist. Included articles were categorized in procedure-based assessment methods and non-procedure-based assessment methods. A second distinction was made between capability for formative and/or summative assessment. RESULTS: In this systematic review, nineteen studies were included. These studies showed large heterogeneity despite categorization. Median quality score was 15 (range 0-26). Fourteen studies were categorized as procedure-based assessment methods (PBA), and five as non-procedure-based assessment methods. Three studies were applicable for summative assessment. CONCLUSIONS: The results show a considerable diversity in assessment methods with varying quality and suitability. To prevent a sprawl of assessment methods, we argue for selection and development of available high-quality assessment methods. A procedure-based structure combined with an objective assessment scale and possibility for summative assessment should be cornerstones.


Assuntos
Cirurgia Colorretal , Procedimentos Cirúrgicos do Sistema Digestório , Laparoscopia , Humanos , Cirurgia Colorretal/métodos , Laparoscopia/métodos
6.
Surg Endosc ; 37(12): 9139-9146, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37814165

RESUMO

INTRODUCTION: Intraoperative perfusion imaging may help the surgeon in creating the intestinal anastomoses in optimally perfused tissue. Laser speckle contrast imaging (LSCI) is such a perfusion visualisation technique that is characterized by dye-free, real-time and continuous imaging. Our aim is to validate the use of a novel, dye-free visualization tool to detect perfusion deficits using laparoscopic LSCI. METHODS: In this multi-centre study, a total of 64 patients were imaged using the laparoscopic laser speckle contrast imager. Post-operatively, surgeons were questioned if the additional visual feedback would have led to a change in clinical decision-making. RESULTS: This study suggests that the laparoscopic laser speckle contrast imager PerfusiX-Imaging is able to image colonic perfusion. All images were clear and easy to interpret for the surgeon. The device is non-disruptive of the surgical procedure with an average added surgical time of 2.5 min and no change in surgical equipment. The potential added clinical value is accentuated by the 17% of operating surgeons indicating a change in anastomosis location. Further assessment and analysis of both white light and PerfusiX perfusion images by non-involved, non-operating surgeons showed an overall agreement of 80%. CONCLUSION: PerfusiX-Imaging is a suitable laparoscopic perfusion imaging system for colon surgery that can visualize perfusion in real-time with no change in surgical equipment. The additional visual feedback could help guide the surgeons in placing the anastomosis at the most optimal site.


Assuntos
Laparoscopia , Imagem de Contraste de Manchas a Laser , Humanos , Estudos Prospectivos , Intestinos/diagnóstico por imagem , Intestinos/cirurgia , Perfusão , Imagem de Perfusão/métodos , Fluxo Sanguíneo Regional
7.
BMC Med Educ ; 23(1): 154, 2023 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-36907871

RESUMO

OBJECTIVE: Repeated practice, or spacing, can improve various types of skill acquisition. Similarly, virtual reality (VR) simulators have demonstrated their effectiveness in fostering surgical skill acquisition and provide a promising, realistic environment for spaced training. To explore how spacing impacts VR simulator-based acquisition of surgical psychomotor skills, we performed a systematic literature review. METHODS: We systematically searched the databases PubMed, PsycINFO, Psychology and Behavioral Sciences Collection, ERIC and CINAHL for studies investigating the influence of spacing on the effectiveness of VR simulator training focused on psychomotor skill acquisition in healthcare professionals. We assessed the quality of all included studies using the Medical Education Research Study Quality Instrument (MERSQI) and the risk of bias using the Cochrane Collaboration's risk of bias assessment tool. We extracted and aggregated qualitative data regarding spacing interval, psychomotor task performance and several other performance metrics. RESULTS: The searches yielded 1662 unique publications. After screening the titles and abstracts, 53 publications were retained for full text screening and 7 met the inclusion criteria. Spaced training resulted in better performance scores and faster skill acquisition when compared to control groups with a single day (massed) training session. Spacing across consecutive days seemed more effective than shorter or longer spacing intervals. However, the included studies were too heterogeneous in terms of spacing interval, obtained performance metrics and psychomotor skills analysed to allow for a meta-analysis to substantiate our outcomes. CONCLUSION: Spacing in VR simulator-based surgical training improved skill acquisition when compared to massed training. The overall number and quality of available studies were only moderate, limiting the validity and generalizability of our findings.


Assuntos
Treinamento por Simulação , Realidade Virtual , Humanos , Competência Clínica , Destreza Motora , Desempenho Psicomotor , Treinamento por Simulação/métodos , Interface Usuário-Computador
8.
Ann Surg ; 275(5): 911-918, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33605581

RESUMO

OBJECTIVE: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors. BACKGROUND: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning. METHODS: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision. RESULTS: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision. CONCLUSIONS: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning.


Assuntos
Neoplasias Esofágicas , Laparoscopia , Cirurgiões , Estudos de Coortes , Neoplasias Esofágicas/complicações , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Hospitais , Humanos , Laparoscopia/métodos , Curva de Aprendizado , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Resultado do Tratamento
9.
Ann Surg ; 276(5): 806-813, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-35880759

RESUMO

OBJECTIVE: This study investigated the patterns, predictors, and survival of recurrent disease following esophageal cancer surgery. BACKGROUND: Survival of recurrent esophageal cancer is usually poor, with limited prospects of remission. METHODS: This nationwide cohort study included patients with distal esophageal and gastroesophageal junction adenocarcinoma and squamous cell carcinoma after curatively intended esophagectomy in 2007 to 2016 (follow-up until January 2020). Patients with distant metastases detected during surgery were excluded. Univariable and multivariable logistic regression were used to identify predictors of recurrent disease. Multivariable Cox regression was used to determine the association of recurrence site and treatment intent with postrecurrence survival. RESULTS: Among 4626 patients, 45.1% developed recurrent disease a median of 11 months postoperative, of whom most had solely distant metastases (59.8%). Disease recurrences were most frequently hepatic (26.2%) or pulmonary (25.1%). Factors significantly associated with disease recurrence included young age (≤65 y), male sex, adenocarcinoma, open surgery, transthoracic esophagectomy, nonradical resection, higher T-stage, and tumor positive lymph nodes. Overall, median postrecurrence survival was 4 months [95% confidence interval (95% CI): 3.6-4.4]. After curatively intended recurrence treatment, median survival was 20 months (95% CI: 16.4-23.7). Survival was more favorable after locoregional compared with distant recurrence (hazard ratio: 0.74, 95% CI: 0.65-0.84). CONCLUSIONS: This study provides important prognostic information assisting in the surveillance and counseling of patients after curatively intended esophageal cancer surgery. Nearly half the patients developed recurrent disease, with limited prospects of survival. The risk of recurrence was higher in patients with a higher tumor stage, nonradical resection and positive lymph node harvest.


Assuntos
Adenocarcinoma , Neoplasias Esofágicas , Adenocarcinoma/patologia , Estudos de Coortes , Esofagectomia , Humanos , Metástase Linfática , Masculino , Recidiva Local de Neoplasia/patologia , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida
10.
Surg Endosc ; 36(1): 446-460, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33608767

RESUMO

BACKGROUND: Minimally invasive esophagectomy (MIE) is a complex and technically demanding procedure with a long learning curve, which is associated with increased morbidity and mortality. To master MIE, training in essential steps is crucial. Yet, no consensus on essential steps of MIE is available. The aim of this study was to achieve expert consensus on essential steps in Ivor Lewis and McKeown MIE through Delphi methodology. METHODS: Based on expert opinion and peer-reviewed literature, essential steps were defined for Ivor Lewis (IL) and McKeown (McK) MIE. In a round table discussion, experts finalized the lists of steps and an online Delphi questionnaire was sent to an international expert panel (7 European countries) of minimally invasive upper GI surgeons. Based on replies and comments, steps were adjusted and rephrased and sent in iterative fashion until consensus was achieved. RESULTS: Two Delphi rounds were conducted and response rates were 74% (23 out of 31 experts) for the first and 81% (27 out of 33 experts) for the second round. Consensus was achieved on 106 essential steps for both the IL and McK approach. Cronbach's alpha in the first round was 0.78 (IL) and 0.78 (McK) and in the second round 0.92 (IL) and 0.88 (McK). CONCLUSIONS: Consensus among European experts was achieved on essential surgical steps for both Ivor Lewis and McKeown minimally invasive esophagectomy.


Assuntos
Neoplasias Esofágicas , Esofagectomia , Consenso , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Humanos , Curva de Aprendizado , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos
11.
Minim Invasive Ther Allied Technol ; 31(6): 865-871, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34699305

RESUMO

INTRODUCTION: Global rating scales (GRSs) such as the Objective Structured Assessment of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Surgery (GOALS) are assessment methods for surgical procedures. The aim of this study was to establish construct validity of Procedure-Based Assessment (PBA) and to compare PBA with GRSs for laparoscopic cholecystectomy. MATERIAL AND METHODS: OSATS and GOALS GRSs were compared with PBA in their ability to discriminate between levels of performance between trainees who can perform the procedure independently and those who cannot. Three groups were formed based on the number of procedures performed by the trainee: novice (1-10), intermediate (11-20) and experienced (>20). Differences between groups were assessed using the Kruskal-Wallis and Mann-Whitney U tests. RESULTS: Increasing experience correlated significantly with higher GRSs and PBA scores (all p < .001). Scores of novice and intermediate groups overlapped substantially on the OSATS (p = .1) and GOALS (p = .1), while the PBA discriminated between these groups (p = .03). The median score in the experienced group was higher with less dispersion for PBA (97.2[85.3-100]) compared to OSATS (82.1[60.7-100]) and GOALS (80[60-100]). CONCLUSION: For assessing skill level or the capability of performing a laparoscopic cholecystectomy independently, PBA has a higher discriminative ability compared to the GRSs.


Assuntos
Colecistectomia Laparoscópica , Laparoscopia , Competência Clínica
12.
Dig Surg ; 36(1): 27-32, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-29414813

RESUMO

BACKGROUND: There is ongoing debate whether laparoscopic right colectomy is superior to open surgery. The purpose of this study was to address this issue and arrive at a consensus using data from a national database. METHODS: Patients who underwent elective open or laparoscopic right colectomy for colorectal cancer during the period 2009-2013 were identified from the Dutch Surgical Colorectal Audit. Complications that occurred within 30 days after surgery and 30-day mortality rates were calculated and compared between open and laparoscopic resection. RESULTS: In total, 12,006 patients underwent elective open or laparoscopic surgery for right-sided colorectal cancer. Of these, 6,683 (55.7%) underwent open resection and 5,323 (44.3%) underwent laparoscopic resection. Complications occurred within 30 days after surgery in the laparoscopic group in 26.1% of patients and in 32.1% of patients in the open group (p < 0.001). Thirty-day mortality was also significantly lower in the laparoscopic group (2.2 vs. 3.6% p < 0.001). CONCLUSION: In this non-randomized, descriptive study conducted in the Netherlands, open right colectomy seems to have a higher risk for complications and mortality as compared to laparoscopic right colectomy, even after correction for confounding factors.


Assuntos
Colectomia/métodos , Neoplasias do Colo/cirurgia , Laparoscopia , Idoso , Idoso de 80 Anos ou mais , Colectomia/efeitos adversos , Colectomia/mortalidade , Colo Ascendente/cirurgia , Colo Transverso/cirurgia , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Complicações Pós-Operatórias/etiologia , Reoperação , Estudos Retrospectivos
13.
BMC Cancer ; 18(1): 142, 2018 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-29409469

RESUMO

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. METHODS: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy. DISCUSSION: If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care.


Assuntos
Ensaios Clínicos Fase III como Assunto/métodos , Neoplasias Esofágicas/terapia , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Quimiorradioterapia/métodos , Análise Custo-Benefício , Intervalo Livre de Doença , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Neoplasias Esofágicas/diagnóstico por imagem , Esofagectomia/métodos , Humanos , Terapia Neoadjuvante , Avaliação de Resultados em Cuidados de Saúde/economia , Avaliação de Resultados em Cuidados de Saúde/métodos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos
14.
Surg Endosc ; 30(6): 2288-300, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-26416369

RESUMO

BACKGROUND: There is no widely used method to evaluate procedure-specific laparoscopic skills. The first aim of this study was to develop a procedure-based assessment method. The second aim was to compare its validity, reliability and feasibility with currently available global rating scales (GRSs). METHODS: An independence-scaled procedural assessment was created by linking the procedural key steps of the laparoscopic cholecystectomy to an independence scale. Subtitled and blinded videos of a novice, an intermediate and an almost competent trainee, were evaluated with GRSs (OSATS and GOALS) and the independence-scaled procedural assessment by seven surgeons, three senior trainees and six scrub nurses. Participants received a short introduction to the GRSs and independence-scaled procedural assessment before assessment. The validity was estimated with the Friedman and Wilcoxon test and the reliability with the intra-class correlation coefficient (ICC). A questionnaire was used to evaluate user opinion. RESULTS: Independence-scaled procedural assessment and GRS scores improved significantly with surgical experience (OSATS p = 0.001, GOALS p < 0.001, independence-scaled procedural assessment p < 0.001). The ICCs of the OSATS, GOALS and independence-scaled procedural assessment were 0.78, 0.74 and 0.84, respectively, among surgeons. The ICCs increased when the ratings of scrub nurses were added to those of the surgeons. The independence-scaled procedural assessment was not considered more of an administrative burden than the GRSs (p = 0.692). DISCUSSION/CONCLUSION: A procedural assessment created by combining procedural key steps to an independence scale is a valid, reliable and acceptable assessment instrument in surgery. In contrast to the GRSs, the reliability of the independence-scaled procedural assessment exceeded the threshold of 0.8, indicating that it can also be used for summative assessment. It furthermore seems that scrub nurses can assess the operative competence of surgical trainees.


Assuntos
Colecistectomia Laparoscópica/educação , Competência Clínica , Educação de Pós-Graduação em Medicina/métodos , Avaliação Educacional/métodos , Adulto , Colecistectomia Laparoscópica/normas , Técnica Delphi , Feminino , Humanos , Internato e Residência , Masculino , Reprodutibilidade dos Testes , Inquéritos e Questionários , Gravação de Videoteipe
15.
Med Educ ; 50(4): 409-27, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26995481

RESUMO

CONTEXT: Current methods of assessing candidates for medical specialties that involve laparoscopic skills suffer from a lack of instruments to assess the ability to work in a minimally invasive surgery environment. OBJECTIVES: A meta-analysis was conducted to investigate whether aptitude assessment can be used to predict variability in the acquisition and performance of laparoscopic skills. METHODS: PubMed, PsycINFO and Google Scholar were searched to November 2014 for published and unpublished studies reporting the measurement of a form of aptitude for laparoscopic skills. The quality of studies was assessed with QUADAS-2. Summary correlations were calculated using a random-effects model. RESULTS: Thirty-four studies were found to be eligible for inclusion; six of these studies used an operating room performance measurement. Laparoscopic skills correlated significantly with visual-spatial ability (r = 0.32, 95% confidence interval [CI] 0.25-0.39; p < 0.001), perceptual ability (r = 0.31, 95% CI 0.22-0.39; p < 0.001), psychomotor ability (r = 0.26, 95% CI 0.10-0.40; p = 0.003) and simulator-based assessment of aptitude (r = 0.64, 95% CI 0.52-0.73; p < 0.001). Three-dimensional dynamic visual-spatial ability showed a significantly higher correlation than intrinsic static visual-spatial ability (p = 0.024). CONCLUSIONS: In general, aptitude assessments are associated with laparoscopic skill level. Simulator-based assessment of aptitude appears to have the potential to represent a job sample and to enable the assessment of all forms of aptitude for laparoscopic surgery at once. A laparoscopy aptitude test can be a valuable additional tool in the assessment of candidates for medical specialties that require laparoscopic skills.


Assuntos
Aptidão , Educação Médica/métodos , Laparoscopia/educação , Testes de Aptidão , Competência Clínica/normas , Educação Médica/normas , Humanos , Laparoscopia/normas , Desempenho Psicomotor/fisiologia , Viés de Publicação , Treinamento por Simulação/métodos , Percepção Espacial/fisiologia , Percepção Visual/fisiologia
16.
Surg Endosc ; 29(9): 2620-7, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25480611

RESUMO

BACKGROUND: While several procedural training curricula in laparoscopic colorectal surgery have been validated and published, none have focused on dividing surgical procedures into well-identified segments, which can be trained and assessed separately. This enables the surgeon and resident to focus on a specific segment, or combination of segments, of a procedure. Furthermore, it will provide a consistent and uniform method of training for residents rotating through different teaching hospitals. The goal of this study was to determine consensus on the key steps of laparoscopic right hemicolectomy and laparoscopic sigmoid colectomy among experts in our University Medical Center and affiliated hospitals. This will form the basis for the INVEST video-assisted side-by-side training curriculum. METHODS: The Delphi method was used for determining consensus on key steps of both procedures. A list of 31 steps for laparoscopic right hemicolectomy and 37 steps for laparoscopic sigmoid colectomy was compiled from textbooks and national and international guidelines. In an online questionnaire, 22 experts in 12 hospitals within our teaching region were invited to rate all steps on a Likert scale on importance for the procedure. RESULTS: Consensus was reached in two rounds. Sixteen experts agreed to participate. Of these 16 experts, 14 (88%) completed the questionnaire for both procedures. Of the 14 who completed the first round, 13 (93%) completed the second round. Cronbach's alpha was 0.79 for the right hemicolectomy and 0.91 for the sigmoid colectomy, showing high internal consistency between the experts. For the right hemicolectomy, 25 key steps were established; for the sigmoid colectomy, 24 key steps were established. CONCLUSION: Expert consensus on the key steps for laparoscopic right hemicolectomy and laparoscopic sigmoid colectomy was reached. These key steps will form the basis for a video-assisted teaching curriculum.


Assuntos
Colectomia/métodos , Técnica Delphi , Laparoscopia/métodos , Colo Sigmoide/cirurgia , Humanos , Países Baixos
17.
Surg Endosc ; 28(5): 1571-8, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24380985

RESUMO

BACKGROUND: Cholecystectomy was one of the first surgical procedures to be performed with laparoscopy in the 1980s. Currently, two operation setups generally are used to perform a laparoscopic cholecystectomy: the French and the American position. In the French position, the patient lies in the lithotomy position, whereas in the American position, the patient lies supine with the left arm in abduction. To find an ergonomic difference between the two operation setups the movements of the surgeon's vertebral column were analyzed in a crossover study. METHODS: The posture of the surgeon's vertebral column was recorded intraoperatively using an electromagnetic motion-tracking system with three sensors attached to the head and to the trunk at the levels of Th1 and S1. A three-dimensional posture analysis of the cervical and thoracolumbar spine was performed to evaluate four surgeons removing a gallbladder in the French and American position. The body angles assessed were flexion/extension of the cervical and thoracolumbar spine, axial rotation of the cervical and thoracolumbar spine, lateroflexion of the cervical and thoracolumbar spine, and the orientation of the head in the sagittal plane. For each body angle, the mean, the percentage of operation time within an ergonomic acceptable range, and the relative frequencies were calculated and compared. RESULTS: No statistical difference was observed in the mean body angles or in the percentages of operation time within an acceptable range between the French and the American position. The relative frequencies of the body angles might indicate a trend toward slight thoracolumbar flexion in the French position. CONCLUSION: In a modern dedicated minimally invasive surgery suite, the body posture of the neck and trunk and the orientation of the head did not differ significantly between the French and American position.


Assuntos
Colecistectomia Laparoscópica/métodos , Ergonomia/métodos , Movimento (Física) , Orientação/fisiologia , Médicos , Postura , Coluna Vertebral/fisiologia , Humanos , Período Intraoperatório , Monitorização Fisiológica/métodos , Posicionamento do Paciente
18.
Cochrane Database Syst Rev ; (4): CD005200, 2014 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-24737031

RESUMO

BACKGROUND: Colorectal cancer including rectal cancer is the third most common cause of cancer deaths in the western world. For colon carcinoma, laparoscopic surgery is proven to result in faster postoperative recovery, fewer complications and better cosmetic results with equal oncologic results. These short-term benefits are expected to be similar for laparoscopic rectal cancer surgery. However, the oncological safety of laparoscopic surgery for rectal cancer remained controversial due to the lack of definitive long-term results. Thus, the expected short-term benefits can only be of interest when oncological results are at least equal. OBJECTIVES: To evaluate the differences in short- and long-term results after elective laparoscopic total mesorectal excision (LTME) for the resection of rectal cancer compared with open total mesorectal excision (OTME). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2013, Issue 2), MEDLINE (January 1990 to February 2013), EMBASE (January 1990 to February 2013), ClinicalTrials.gov (February 2013) and Current Controlled Trials (February 2013). We handsearched the reference lists of the included articles for missed studies. SELECTION CRITERIA: Only randomised controlled trials (RCTs) comparing LTME and OTME, reporting at least one of our outcome measures, was considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality according to the CONSORT statement, and resolved disagreements by discussion. We rated the quality of the evidence using GRADE methods. MAIN RESULTS: We identified 45 references out of 953 search results, of which 14 studies met the inclusion criteria involving 3528 rectal cancer patients. We did not consider the risk of bias of the included studies to have impacted on the quality of the evidence. Data were analysed according to an intention-to-treat principle with a mean conversion rate of 14.5% (range 0% to 35%) in the laparoscopic group.There was moderate quality evidence that laparoscopic and open TME had similar effects on five-year disease-free survival (OR 1.02; 95% CI 0.76 to1.38, 4 studies, N = 943). The estimated effects of laparoscopic and open TME on local recurrence and overall survival were similar, although confidence intervals were wide, both with moderate quality evidence (local recurrence: OR 0.89; 95% CI 0.57 to1.39 and overall survival rate: OR 1.15; 95% CI 0.87 to1.52). There was moderate to high quality evidence that the number of resected lymph nodes and surgical margins were similar between the two groups.For the short-term results, length of hospital stay was reduced by two days (95% CI -3.22 to -1.10), moderate quality evidence), and the time to first defecation was shorter in the LTME group (-0.86 days; 95% CI -1.17 to -0.54). There was moderate quality evidence that 30 days morbidity were similar in both groups (OR 0.94; 95% CI 0.8 to 1.1). There were fewer wound infections (OR 0.68; 95% CI 0.50 to 0.93) and fewer bleeding complications (OR 0.30; 95% CI 0.10 to 0.93) in the LTME group.There was no clear evidence of any differences in quality of life after LTME or OTME regarding functional recovery, bladder and sexual function. The costs were higher for LTME with differences up to GBP 2000 for direct costs only. AUTHORS' CONCLUSIONS: We have found moderate quality evidence that laparoscopic total mesorectal excision (TME) has similar effects to open TME on long term survival outcomes for the treatment of rectal cancer. The quality of the evidence was downgraded due to imprecision and further research could impact on our confidence in this result. There is moderate quality evidence that it leads to better short-term post-surgical outcomes in terms of recovery for non-locally advanced rectal cancer. Currently results are consistent in showing a similar disease-free survival and overall survival, and for recurrences after at least three years and up to 10 years, although due to imprecision we cannot rule out superiority of either approach. We await long-term data from a number of ongoing and recently completed studies to contribute to a more robust analysis of long-term disease free, overall survival and local recurrence.


Assuntos
Laparoscopia , Neoplasias Retais/cirurgia , Reto/cirurgia , Conversão para Cirurgia Aberta/estatística & dados numéricos , Procedimentos Cirúrgicos Eletivos , Humanos , Resultado do Tratamento
19.
Obes Surg ; 34(4): 1113-1121, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38400947

RESUMO

PURPOSE: Feedback on technical and procedural skills is essential during the training of residents and fellows. The aim of this study was to assess the performance of a newly created instrument for the assessment of operative skills using laparoscopic Roux-en-Y gastric bypass (LRYGB) video fragments. MATERIALS AND METHODS: A new procedure-based assessment (PBA) was created by combining LRYGB key steps with a 5-point independence scale. LRYGB performed by residents and surgeons with different levels of expertise were video recorded. Fragments of the pouch creation, gastro-jejunostomy and jejunojejunostomy, were review by 12 expert bariatric surgeons and the operative skills assessed with the PBA, Objective Structured Assessment of Technical Skill (OSATS), and the Bariatric OSATS (BOSATS). The PBA was compared to the OSATS and BOSATS. Mean scores for all items of the different assessments were summarized and compared using a T-test. RESULTS: The scores of the procedural steps were combined and compared for all levels. The mean scores for beginner, intermediate, and expert level were 2.71, 3.70, and 3.90 for the PBA; for the OSATS 1.84, 2.86, and 3.44; and for the BOSATS 2.78, 3.56, and 4.19. Each of these assessments differentiated between the three skill levels (all p < 0.05). CONCLUSION: The PBA discriminates well between different levels of operative skills. Similar patterns were found for the OSATS and BOSATS, showing that the randomly selected video fragments are representative samples for assessing skill level. Future research will demonstrate whether these results can be extrapolated to clinical training, and which scores allow for procedure certification.


Assuntos
Derivação Gástrica , Internato e Residência , Laparoscopia , Obesidade Mórbida , Cirurgiões , Humanos , Derivação Gástrica/educação , Obesidade Mórbida/cirurgia , Laparoscopia/educação , Competência Clínica
20.
Dig Surg ; 30(4-6): 265-9, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23970165

RESUMO

BACKGROUND: Laparoscopic subtotal colectomy (STC) is a complex procedure. It is possible that short-term benefits for segmental resections cannot be attributed to this complex procedure. This study aims to assess differences in short-term results for laparoscopic versus open STC during a 15-year single-institute experience. METHODS: We reviewed consecutive patients undergoing laparoscopic or open elective or subacute STC from January 1997 to December 2012. RESULTS: Fifty-six laparoscopic and 50 open STCs were performed. The operation time was significantly longer in the laparoscopic group, median 266 min (range 121-420 min), compared to 153 min (range 90-408 min) in the open group (p < 0.001). Median hospital stay showed no statistical difference, 14 days (range 1-129 days) in the laparoscopic and 13 days (range 1-85 days) in the open group. Between-group postoperative complications were not statistically different. CONCLUSIONS: Laparoscopic STC has short-term results similar to the open procedure, except for a longer operation time. The laparoscopic approach for STC is therefore only advisable in selected patients combined with extensive preoperative counseling.


Assuntos
Colectomia/estatística & dados numéricos , Doenças Inflamatórias Intestinais/cirurgia , Laparoscopia/estatística & dados numéricos , Fístula Anastomótica/etiologia , Colecistectomia/estatística & dados numéricos , Colecistite/etiologia , Colecistite/cirurgia , Colectomia/efeitos adversos , Feminino , Humanos , Laparoscopia/efeitos adversos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Reoperação , Resultado do Tratamento
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