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1.
Hernia ; 2024 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-38760626

RESUMEN

PURPOSE: The TransREctus sheath PrePeritoneal procedure (TREPP) was introduced as an alternative open and preperitoneal technique for inguinal hernia mesh repair, demonstrating safety and efficacy in retro- and prospective studies. However, little is known about the technique's inherent learning curve. In this study, we aimed to determine TREPP learning curve effects after its implementation in high-volume surgical practice. METHODS: All primary, unilateral TREPP procedures performed in the first three years after implementation (between January 2016 and December 2018) were included out of a large preconstructed regional inguinal hernia database. Data were analyzed on outcome (i.e., surgical complications, hernia recurrences, postoperative pain). Learning curve effects were analyzed by assessing outcome in relation to surgeon experience. RESULTS: In total, 422 primary, unilateral TREPP procedures were performed in 419 patients. In three patients a unilateral TREPP procedure was performed on both sides separated in time. A total of 99 surgical complications were registered in 83 procedures (19.6% of all procedures), most commonly inguinal postoperative pain (8%) and bleeding complications (7%). Hernia recurrences were observed in 17 patients (4%). No statistically significant differences on outcome were found between different surgeon experience (< 40 procedures, 40-80 procedures, > 80 procedures). CONCLUSION: Implementation of TREPP seems not to be associated with a notable increase of adverse events. We were not able to detect a clear learning curve limit, potentially suggesting a relatively short learning curve among already experienced hernia surgeons compared to other guideline techniques.

2.
Ann Surg ; 276(1): 38-45, 2022 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-34966064

RESUMEN

OBJECTIVE: To investigate the effects of PFR after LAR compared to usual care without PFR. SUMMARY OF BACKGROUND DATA: Functional complaints, including fecal incontinence, often occur after LAR for rectal cancer. Controversy exists about the effectiveness of PFR in improving such postoperative functional outcomes. METHODS: This was a multicenter, randomized controlled trial involving 17 Dutch centers. Patients after LAR for rectal cancer were randomly assigned (1:1) to usual care or PFR and stratified by sex and administration of neoadjuvant therapy. Selection was not based on severity of complaints at baseline. Baseline measurements were taken 3 months after surgery without temporary stoma construction or 6 weeks after stoma closure. The primary outcome measure was the change in Wexner incontinence scores 3 months after randomization. Secondary outcomes were fecal incontinence-related quality of life, colorectal-specific quality of life, and the LARS scores. RESULTS: Between October 2017 and March 2020, 128 patients were enrolled and 106 randomly assigned (PFR n = 51, control n = 55); 95 patients (PFR n = 44, control n = 51) were assessable for final analysis. PFR did not lead to larger changes in Wexner incontinence scores in nonselected patients after LAR compared to usual care [PFR: -2.3, 95% confidence interval (CI) -3.3 to -1.4, control: -1.3, 95% CI -2.2 to -0.4, P = 0.13]. However, PFR was associated with less urgency at follow-up (odds ratio 0.22, 95% CI 0.06-0.86). Patients without near-complete incontinence reported larger Wexner score improvements after PFR (PFR: -2.1, 95% CI -3.1 to -1.1, control: -0.7, 95% CI -1.6 to 0.2, P = 0.045). For patients with at least moderate incontinence PFR resulted in relevant improvements in all fecal incontinence-related quality of life domains, while the control group deteriorated. These improvements were even larger when patients with near-complete incontinence were excluded. No serious adverse PFR-related events occurred. CONCLUSION: No benefit was found of PFR in all patients but several subgroups were identified that did benefit from PFR, such as patients with urgency or with at least moderate incontinence and no near-complete incontinence. A selective referral policy (65%-85% of all patients) is suggested to improve postoperative functional outcomes for patients after LAR for rectal cancer. TRIAL REGISTRATION: Netherlands Trial Registration, NTR5469, registered on 3 September 2015.


Asunto(s)
Incontinencia Fecal , Neoplasias del Recto , Humanos , Países Bajos , Diafragma Pélvico/cirugía , Calidad de Vida , Neoplasias del Recto/cirugía , Resultado del Tratamiento
3.
Hernia ; 25(5): 1265-1270, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-33067735

RESUMEN

PURPOSE: Results of the most commonly used inguinal hernia repair techniques often originate from expert centers or from randomized controlled studies. In this study, we portray daily-practice results of a high-volume, regional surgical group in the Netherlands, comparing TREPP (open (posterior) transrectus sheath pre-peritoneal) with Lichtenstein (open anterior) and TEP (endoscopic (posterior) totally extraperitoneal). We hypothesize that the TREPP shows more favorable outcome compared to the current gold standard procedures: TEP and Lichtenstein. METHODS: Between January 2016 and December 2018, 3285 consecutive patients underwent surgical treatment and were included for analysis. The outcome measures were postoperative pain, recurrence rate and other surgical complications. Propensity-score matching was used to address potential selection bias. RESULTS: After propensity-score matching, there was no statistically significant difference in postoperative pain in the TREPP group compared to the Lichtenstein group (TREPP 7.3% versus Lichtenstein 6.3%; p = 0.67) nor in TREPP compared to TEP (TREPP 7.4% versus TEP 4.1%; p = 0.064). There was no statistically significant difference in recurrences in the TREPP group compared to Lichtenstein (3.8% vs 2.5%; p = 0.42), nor in the TREPP versus TEP comparison (3.9% vs 2.8%; p = 0.55) CONCLUSION: This study compares TREPP with Lichtenstein and TEP in the presence of postoperative pain, recurrences and other adverse outcomes. After propensity-score matching, no statistically significant difference in postoperative pain or recurrences remained between either TREPP compared to Lichtenstein, or TREPP compared to TEP. Based on these results, TREPP, Lichtenstein and TEP showed comparable results in postoperative pain, recurrences and other surgical site complications.


Asunto(s)
Hernia Inguinal , Laparoscopía , Hernia Inguinal/cirugía , Herniorrafia/efectos adversos , Hospitales de Alto Volumen , Humanos , Dolor Postoperatorio/epidemiología , Dolor Postoperatorio/etiología , Peritoneo/cirugía , Recurrencia , Mallas Quirúrgicas , Resultado del Tratamiento
4.
Surg J (N Y) ; 6(2): e62-e66, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32258411

RESUMEN

Background Patients with strangulated inguinal hernia (SIH) require emergency surgical treatment. International guidelines do not specify the surgical technique of preference. Frequently, an open anterior approach such as the Lichtenstein technique is used. The TransREctus sheath Pre-Peritoneal (TREPP) technique is an alternative, open posterior approach, which has shown promising results in the elective treatment of inguinal hernias. This study aims to evaluate the feasibility and safety of the TREPP technique in the emergency setting of SIHs. Materials and Methods After medical ethical approval was warranted, all consecutive patients, who underwent emergency TREPP (e-TREPP) at a high-volume hernia institute, were retrospectively included from 2006 up to and including 2016. Data retrieved from the electronic patient files were combined with the findings during a long-term outcome physical investigation at an outpatient department visit. e-TREPP was, prior to the start of the study, defined as TREPP performed immediately at the operation room. Results Thirty-three patients underwent e-TREPP for SIH. Ten patients were clinically evaluated, ten patients were deceased, nine patients could not be contacted, and four patients did not or could not consent. Of the ten deceased patients, one patient died perioperatively due to massive aspiration followed by cardiac arrest. Nine patients died due to other causes. Two patients developed a recurrence after (after 13 days and 16 months respectively). Two patients were surgically treated for a wound infection (mesh removal in one). No patient reported chronic postoperative inguinal pain. Conclusion e-TREPP in experienced hands seems feasible and safe (Level of Evidence 4) for the treatment of patients with strangulated inguinal hernia, with percentages of postoperative complications comparable to other techniques.

5.
Trials ; 21(1): 112, 2020 Jan 28.
Artículo en Inglés | MEDLINE | ID: mdl-31992358

RESUMEN

BACKGROUND: After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment. METHODS: The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes. DISCUSSION: The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial. TRIAL REGISTRATION: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.


Asunto(s)
Incontinencia Fecal/rehabilitación , Diafragma Pélvico , Modalidades de Fisioterapia , Complicaciones Posoperatorias/rehabilitación , Proctectomía , Neoplasias del Recto/cirugía , Análisis Costo-Beneficio , Incontinencia Fecal/economía , Incontinencia Fecal/fisiopatología , Incontinencia Fecal/psicología , Costos de la Atención en Salud , Humanos , Países Bajos , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/psicología , Calidad de Vida
6.
BMC Cancer ; 18(1): 450, 2018 04 20.
Artículo en Inglés | MEDLINE | ID: mdl-29678145

RESUMEN

BACKGROUND: Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer. METHODS: This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4b, N0-3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study. DISCUSSION: In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of €916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems. TRIAL REGISTRATION: NCT03208621 . This trial was registered prospectively on June 30, 2017.


Asunto(s)
Laparoscopía , Estadificación de Neoplasias , Tomografía de Emisión de Positrones , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/patología , Adenocarcinoma/diagnóstico por imagen , Adenocarcinoma/patología , Femenino , Humanos , Laparoscopía/métodos , Masculino , Imagen Multimodal/métodos , Estadificación de Neoplasias/métodos , Tomografía de Emisión de Positrones/métodos , Estudios Prospectivos , Tomografía Computarizada por Rayos X , Flujo de Trabajo
7.
Ann Surg Oncol ; 24(7): 1828-1834, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28303427

RESUMEN

INTRODUCTION: In patients with potentially resectable esophageal cancer (EC), the value of endoscopic ultrasonography (EUS) after fluorine-18 labeled fluorodeoxyglucose positron emission tomography with computed tomography (18F-FDG-PET/CT) is questionable. Retrospectively, we assessed the impact of EUS after PET/CT on the given treatment in EC patients. METHODS: During the period 2009-2015, 318 EC patients were staged as T1-4aN0-3M0 with hybrid 18F-FDG-PET/CT or 18F-FDG-PET with CT and EUS if applicable in a nonspecific order. We determined the impact of EUS on the given treatment in 279 patients who also were staged with EUS. EUS had clinical consequences if it changed curability, extent of radiation fields or lymph node resection (AJCC stations 2-5), and when the performed fine-needle aspiration (FNA) provided conclusive information of suspicious lymph node. RESULTS: EUS had an impact in 80 (28.7%) patients; it changed the radiation field in 63 (22.6%), curability in 5 (1.8%), lymphadenectomy in 48 (17.2%), and FNA was additional in 21 (7.5%). In patients treated with nCRT (n = 194), EUS influenced treatment in 53 (27.3%) patients; in 38 (19.6%) the radiation field changed, in 3 (1.5%) the curability, in 35 (18.0%) the lymphadenectomy, and in 17 (8.8%) FNA was additional. EUS influenced both the extent of radiation field and nodal resection in 31 (16.0%) nCRT patients. CONCLUSIONS: EUS had an impact on the given treatment in approximately 29%. In most patients, the magnitude of EUS found expression in the extent of radiotherapy target volume delineation to upper/high mediastinal lymph nodes.


Asunto(s)
Adenocarcinoma/patología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Escamosas/patología , Endosonografía/métodos , Neoplasias Esofágicas/patología , Fluorodesoxiglucosa F18 , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Adenocarcinoma/diagnóstico por imagen , Adenocarcinoma/terapia , Anciano , Biopsia con Aguja Fina , Carcinoma de Células Escamosas/diagnóstico por imagen , Carcinoma de Células Escamosas/terapia , Terapia Combinada , Neoplasias Esofágicas/diagnóstico por imagen , Neoplasias Esofágicas/terapia , Femenino , Estudios de Seguimiento , Humanos , Escisión del Ganglio Linfático , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia
8.
Hernia ; 20(3): 349-56, 2016 06.
Artículo en Inglés | MEDLINE | ID: mdl-27048266

RESUMEN

OBJECTIVE: The aim of this study was to evaluate whether a relation exists between surgical expertise and incidence of chronic postoperative inguinal pain (CPIP) after inguinal hernia repair using the Lichtenstein procedure . BACKGROUND: CPIP after inguinal hernia repair remains a major clinical problem despite many efforts to address this problem. Recently, case volume and specialisation have been found correlated to significant improvement of outcomes in other fields of surgery; to date these important factors have not been reviewed extensively enough in the context of inguinal hernia surgery. METHODS: A systematic literature review was performed to identify randomised controlled trials reporting on the incidence of CPIP after the Lichtenstein procedure and including the expertise of the surgeon. Surgical expertise was subdivided into expert and non-expert. RESULTS: In a total of 16 studies 3086 Lichtenstein procedures were included. In the expert group the incidence of CPIP varied between 6.9 and 11.7 % versus an incidence of 18.1 and 39.4 % in the non-expert group. Due to the heterogeneity between groups no statistical significance could be demonstrated. CONCLUSION: The results of this evaluation suggest that an association between surgical expertise and CPIP is highly likely warranting further analysis in a prospectively designed study.


Asunto(s)
Hernia Inguinal/cirugía , Herniorrafia/efectos adversos , Herniorrafia/normas , Dolor Postoperatorio/etiología , Dolor Crónico/etiología , Competencia Clínica , Herniorrafia/métodos , Herniorrafia/estadística & datos numéricos , Humanos , Incidencia , Mallas Quirúrgicas/efectos adversos
9.
Hernia ; 19(1): 33-43, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25138620

RESUMEN

PURPOSE: Tension-free mesh repair of inguinal hernia has led to uniformly low recurrence rates. Morbidity associated with this operation is mainly related to chronic pain. No consensus guidelines exist for the management of this condition. The goal of this study is to design an expert-based algorithm for diagnostic and therapeutic management of chronic inguinal postoperative pain (CPIP). METHODS: A group of surgeons considered experts on inguinal hernia surgery was solicited to develop the algorithm. Consensus regarding each step of an algorithm proposed by the authors was sought by means of the Delphi method leading to a revised expert-based algorithm. RESULTS: With the input of 28 international experts, an algorithm for a stepwise approach for management of CPIP was created. 26 participants accepted the final algorithm as a consensus model. One participant could not agree with the final concept. One expert did not respond during the final phase. CONCLUSION: There is a need for guidelines with regard to management of CPIP. This algorithm can serve as a guide with regard to the diagnosis, management, and treatment of these patients and improve clinical outcomes. If an expectative phase of a few months has passed without any amelioration of CPIP, a multidisciplinary approach is indicated and a pain management team should be consulted. Pharmacologic, behavioral, and interventional modalities including nerve blocks are essential. If conservative measures fail and surgery is considered, triple neurectomy, correction for recurrence with or without neurectomy, and meshoma removal if indicated should be performed. Surgeons less experienced with remedial operations for CPIP should not hesitate to refer their patients to dedicated hernia surgeons.


Asunto(s)
Algoritmos , Hernia Inguinal/cirugía , Herniorrafia/efectos adversos , Dolor Postoperatorio/etiología , Dolor Crónico/etiología , Consenso , Ingle , Humanos , Internacionalidad , Mallas Quirúrgicas/efectos adversos
10.
Surg Endosc ; 29(8): 2284-90, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-25361658

RESUMEN

BACKGROUND: It has previously been shown that short, pre-operative practice with a simulator, box trainer, or certain video games can temporarily improve one's basic laparoscopic skills; the so-called warm-up effect. In this experiment, we tested the hypothesis that Underground video game made for training basic laparoscopic skills, can also be used for a pre-operative warm-up. MATERIALS AND METHODS: 29 laparoscopic experts were randomized into two different groups, which were tested on two different days. Group 1 (n = 16) did a laparoscopic skill baseline measurement using the FLS peg transfer test and the Top Gun cobra rope drill on day 1, and did the same tests on day 2 after a 15 min session with the Underground game. Group 2 (n = 13) did the same, but started with the video game, followed by baseline measurement on day 2. This way, each participant served as its own control. Video recordings of both tasks were later analyzed by two blinded reviewers. RESULTS: On day 1, group 2 was 14.33 % (P = 0.037) faster in completing the peg transfer test. A trend toward better cobra rope scores is also seen. When comparing the average improvement between both days, group 1--which used the game as a warm-up on day 2--showed a 19.61 % improvement in cobra rope score, compared to a 0.77 % score decrease in group 2 (P = 0.002). CONCLUSIONS: This study shows that the Underground video game can be used as a pre-operative warm-up in an experimental setting.


Asunto(s)
Competencia Clínica , Laparoscopía/educación , Periodo Preoperatorio , Juegos de Video , Adulto , Femenino , Humanos , Masculino , Distribución Aleatoria , Cirujanos
11.
World J Surg ; 38(8): 1922-8, 2014 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-24510248

RESUMEN

INTRODUCTION: After the introduction of mesh in inguinal hernia repair, the focus to improve surgical technique has changed from recurrence to chronic postoperative inguinal pain. At present, the most common surgical techniques are the Lichtenstein hernioplasty and total extraperitoneal procedure. Both techniques have their own specific disadvantages, with regard to potential nerve damage and the necessity of general anesthesia, respectively. OBJECTIVE: The goal of this study was to evaluate the results of a new technique in which the inguinal nerves are not at risk, and in which general anesthesia is not needed: trans rectus sheath extraperitoneal procedure (TREPP). MATERIAL AND METHODS: Between 2006 and 2010, a total of 1,000 patients were treated for inguinal hernia with TREPP. A questionnaire concerning pain, sensibility changes, patient satisfaction, and recurrence was sent to all patients. RESULTS: The questionnaire was completed by 932 patients. Almost 90% of patients had not experienced any pain since the surgical procedure; 8% of patients reported experiencing some pain, but less than preoperatively; and 2% of patients reported an increase in pain postoperatively. Recurrence occurred in 1 and 3% were unsure about this. Reduced sensibility of the scar, scrotum, and upper leg was reported by 12.4, 1.4, and 1.5%, respectively. Overall, 97.4% of patients were satisfied with the results of the surgical procedure. The time period in which TREPP was performed was not associated with any of the outcome measures. CONCLUSION: TREPP has proven to be a feasible new technique for inguinal hernia repair, with excellent results, justifying a randomized controlled trial in which TREPP should be compared with standard techniques.


Asunto(s)
Dolor Crónico/prevención & control , Hernia Inguinal/cirugía , Herniorrafia/métodos , Dolor Postoperatorio/prevención & control , Peritoneo/cirugía , Recto/cirugía , Pared Abdominal/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Dolor Crónico/etiología , Femenino , Herniorrafia/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Recurrencia , Estudios Retrospectivos , Mallas Quirúrgicas , Encuestas y Cuestionarios
12.
Surg Endosc ; 28(2): 537-42, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24061627

RESUMEN

BACKGROUND: Virtual reality (VR) laparoscopic simulators have been around for more than 10 years and have proven to be cost- and time-effective in laparoscopic skills training. However, most simulators are, in our experience, considered less interesting by residents and are often poorly accessible. Consequently, these devices are rarely used in actual training. In an effort to make a low-cost and more attractive simulator, a custom-made Nintendo Wii game was developed. This game could ultimately be used to train the same basic skills as VR laparoscopic simulators ought to. Before such a video game can be implemented into a surgical training program, it has to be validated according to international standards. METHODS: The main goal of this study was to test construct and concurrent validity of the controls of a prototype of the game. In this study, the basic laparoscopic skills of experts (surgeons, urologists, and gynecologists, n = 15) were compared to those of complete novices (internists, n = 15) using the Wii Laparoscopy (construct validity). Scores were also compared to the Fundamentals of Laparoscopy (FLS) Peg Transfer test, an already established assessment method for measuring basic laparoscopic skills (concurrent validity). RESULTS: Results showed that experts were 111 % faster (P = 0.001) on the Wii Laparoscopy task than novices. Also, scores of the FLS Peg Transfer test and the Wii Laparoscopy showed a significant, high correlation (r = 0.812, P < 0.001). CONCLUSIONS: The prototype setup of the Wii Laparoscopy possesses solid construct and concurrent validity.


Asunto(s)
Competencia Clínica , Simulación por Computador , Educación Médica Continua/métodos , Laparoscopía/educación , Interfaz Usuario-Computador , Juegos de Video/normas , Humanos , Médicos/normas
13.
Surg Endosc ; 27(8): 2947-54, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23436098

RESUMEN

BACKGROUND: INtraoperative Video Enhanced Surgical procedure Training (INVEST) is a new training method designed to improve the transition from basic skills training in a skills lab to procedural training in the operating theater. Traditionally, the master-apprentice model (MAM) is used for procedural training in the operating theater, but this model lacks uniformity and efficiency at the beginning of the learning curve. This study was designed to investigate the effectiveness and efficiency of INVEST compared to MAM. METHODS: Ten surgical residents with no laparoscopic experience were recruited for a laparoscopic cholecystectomy training curriculum either by the MAM or with INVEST. After a uniform course in basic laparoscopic skills, each trainee performed six cholecystectomies that were digitally recorded. For 14 steps of the procedure, an observer who was blinded for the type of training determined whether the step was performed entirely by the trainee (2 points), partially by the trainee (1 point), or by the supervisor (0 points). Time measurements revealed the total procedure time and the amount of effective procedure time during which the trainee acted as the operating surgeon. Results were compared between both groups. RESULTS: Trainees in the INVEST group were awarded statistically significant more points (115.8 vs. 70.2; p < 0.001) and performed more steps without the interference of the supervisor (46.6 vs. 18.8; p < 0.001). Total procedure time was not lengthened by INVEST, and the part performed by trainees was significantly larger (69.9 vs. 54.1 %; p = 0.004). CONCLUSIONS: INVEST enhances effectiveness and training efficiency for procedural training inside the operating theater without compromising operating theater time efficiency.


Asunto(s)
Colecistectomía Laparoscópica/educación , Competencia Clínica , Simulación por Computador , Internado y Residencia/métodos , Grabación en Video , Curriculum , Evaluación Educacional , Humanos , Periodo Intraoperatorio , Curva de Aprendizaje , Quirófanos , Reproducibilidad de los Resultados
14.
Ann Oncol ; 23(10): 2619-2626, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22431703

RESUMEN

BACKGROUND: This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. METHODS: This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. RESULTS: The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively. CONCLUSIONS: This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.


Asunto(s)
Neoplasias Colorrectales/patología , Neoplasias Hepáticas/secundario , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Femenino , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/radioterapia , Masculino , Persona de Mediana Edad , Tasa de Supervivencia
15.
Eur J Surg Oncol ; 38(3): 214-21, 2012 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-22244907

RESUMEN

The aim of this study was to determine the incidence and survival of Extramammary Paget's disease (EMPD) and to describe the possible increased risk of tumours after EMPD. All invasive cases diagnosed between 1990 and 2002 were selected from the RARECARE database. Incidence was expressed in European standardized rates. Relative survival was calculated for the period 1995-1999, with a follow-up until 31st December 2003. Standardized incidence ratios of second primary tumours were calculated to reveal possible increased risk after EMPD. European age standardized Incidence of EMPD within Europe is 0.6 per 1000,000 person years. Five-year relative survival for invasive EMPD was 91.2% (95%CI; 83.5-95.4), 8.6 percent of the EMPD patients developed other malignancies. The highest increased risk of developing a second primary tumour was found in the first year of follow-up (SIR:2.0 95%CI; 1.3-2.9), living in the South European region (SIR:2.3 95%CI; 1.5-3.5) or being female (SIR:1.5 95%CI; 1.1-1.9). Female genital organs displayed greatest increased risk of developing a second primary tumour after EMPD (SIR:15,1 95%CI; 0.38-84.23). Due to the increased risk of a second primary tumour after EMPD a thorough search for other tumours during their follow-up is recommended.


Asunto(s)
Neoplasias Primarias Secundarias/epidemiología , Neoplasias Primarias Secundarias/patología , Enfermedad de Paget Extramamaria/epidemiología , Enfermedad de Paget Extramamaria/patología , Adulto , Anciano , Anciano de 80 o más Años , Europa (Continente)/epidemiología , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Pronóstico , Riesgo , Tasa de Supervivencia
16.
Dig Surg ; 28(5-6): 360-6, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-22086121

RESUMEN

OBJECTIVE: Despite improvements in anesthesiology and intensive care medicine, mortality for perforated gastroduodenal ulcer disease remains high. This study was designed to evaluate the results of surgery for perforated ulcer disease and to identify prognostic factors for mortality in order to optimize treatment. PATIENTS AND METHODS: The medical records of 272 patients undergoing emergency surgery for perforated ulcer disease from 2000 to 2005 in two large teaching hospitals and one university hospital in the Netherlands were retrospectively analyzed. Information on 89 pre-, peri- and postoperative data were recorded. Statistical analysis was performed using multiple logistic regression analysis. The primary endpoint was 30-day mortality. RESULTS: The 30-day mortality rate was 16%. Variables associated with 30-day mortality were age, shock, tachycardia, anemia and ASA class. CONCLUSIONS: A relatively low 30-day mortality rate was achieved. Age, shock, tachycardia and anemia were significantly associated with 30-day mortality. Finding that shock, tachycardia and anemia are independently associated with 30-day mortality could indicate that patients are septic upon admission. Improvements in survival might be achieved by early sepsis treatment.


Asunto(s)
Úlcera Duodenal/cirugía , Úlcera Péptica Perforada/mortalidad , Úlcera Péptica Perforada/cirugía , Úlcera Gástrica/cirugía , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Úlcera Duodenal/complicaciones , Urgencias Médicas , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Países Bajos , Úlcera Péptica Perforada/etiología , Estudios Retrospectivos , Choque/complicaciones , Úlcera Gástrica/complicaciones , Taquicardia/complicaciones , Adulto Joven
17.
Surg Endosc ; 25(7): 2261-7, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21359903

RESUMEN

BACKGROUND: The transition from basic skills training in a skills lab to procedure training in the operating theater using the traditional master-apprentice model (MAM) lacks uniformity and efficiency. When the supervising surgeon performs parts of a procedure, training opportunities are lost. To minimize this intervention by the supervisor and maximize the actual operating time for the trainee, we created a new training method called INtraoperative Video-Enhanced Surgical Training (INVEST). METHODS: Ten surgical residents were trained in laparoscopic cholecystectomy either by the MAM or with INVEST. Each trainee performed six cholecystectomies that were objectively evaluated on an Objective Structured Assessment of Technical Skills (OSATS) global rating scale. Absolute and relative improvements during the training curriculum were compared between the groups. A questionnaire evaluated the trainee's opinion on this new training method. RESULTS: Skill improvement on the OSATS global rating scale was significantly greater for the trainees in the INVEST curriculum compared to the MAM, with mean absolute improvement 32.6 versus 14.0 points and mean relative improvement 59.1 versus 34.6% (P=0.02). CONCLUSION: INVEST significantly enhances technical and procedural skill development during the early learning curve for laparoscopic cholecystectomy. Trainees were positive about the content and the idea of the curriculum.


Asunto(s)
Colecistectomía Laparoscópica/educación , Competencia Clínica , Educación de Postgrado en Medicina/métodos , Cirugía Torácica Asistida por Video/educación , Curriculum , Evaluación Educacional , Humanos , Internado y Residencia , Curva de Aprendizaje , Países Bajos , Selección de Paciente , Reproducibilidad de los Resultados , Encuestas y Cuestionarios
18.
Surg Endosc ; 23(10): 2332-7, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19263159

RESUMEN

BACKGROUND: Performing minimally invasive surgery (MIS) in a conventional operating room (OR) requires additional specialized equipment otherwise stored outside the OR. Before the procedure, the OR team must collect, prepare, and connect the equipment, then take it away afterward. These extra tasks pose a thread to OR efficiency and may lengthen turnover times. The dedicated MIS suite has permanently installed laparoscopic equipment that is operational on demand. This study presents two experiments that quantify the superior efficiency of the MIS suite in the interoperative period. METHODS: Preoperative setup and postoperative breakdown times in the conventional OR and the MIS suite in an experimental setting and in daily practice were analyzed. In the experimental setting, randomly chosen OR teams simulated the setup and breakdown for a standard laparoscopic cholecystectomy (LC) and a complex laparoscopic sigmoid resection (LS). In the clinical setting, the interoperative period for 66 LCs randomly assigned to the conventional OR or the MIS suite were analyzed. RESULTS: In the experimental setting, the setup and breakdown times were significantly shorter in the MIS suite. The difference between the two types of OR increased for the complex procedure: 2:41 min for the LC (p < 0.001) and 10:47 min for the LS (p < 0.001). In the clinical setting, the setup and breakdown times as a whole were not reduced in the MIS suite. Laparoscopic setup and breakdown times were significantly shorter in the MIS suite (mean difference, 5:39 min; p < 0.001). CONCLUSION: Efficiency during the interoperative period is significantly improved in the MIS suite. The OR nurses' tasks are relieved, which may reduce mental and physical workload and improve job satisfaction and patient safety. Due to simultaneous tasks of other disciplines, an overall turnover time reduction could not be achieved.


Asunto(s)
Eficiencia Organizacional , Procedimientos Quirúrgicos Mínimamente Invasivos , Quirófanos/organización & administración , Colecistectomía Laparoscópica , Colon Sigmoide/cirugía , Estudios Cruzados , Ergonomía , Humanos
19.
Surg Endosc ; 23(6): 1279-85, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-18830751

RESUMEN

BACKGROUND: With minimally invasive surgery (MIS), a man-machine environment was brought into the operating room, which created mental and physical challenges for the operating team. The science of ergonomics analyzes these challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained. This review aimed to formulate the ergonomic challenges related to monitor positioning in MIS. Background and guidelines are formulated for optimal ergonomic monitor positioning within the possibilities of the modern MIS suite, using multiple monitors suspended from the ceiling. METHODS: All evidence-based experimental ergonomic studies conducted in the fields of laparoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches and selected for quality and applicability. Data from ergonomic studies were evaluated in terms of effectiveness and efficiency as well as comfort and safety aspects. Recommendations for individual monitor positioning are formulated to create a personal balance between these two ergonomic aspects. RESULTS: Misalignment in the eye-hand-target axis because of limited freedom in monitor positioning is recognized as an important ergonomic drawback during MIS. Realignment of the eye-hand-target axis improves personal values of comfort and safety as well as procedural values of effectiveness and efficiency. CONCLUSIONS: Monitor position is an important ergonomic factor during MIS. In the horizontal plain, the monitor should be straight in front of each person and aligned with the forearm-instrument motor axis to avoid axial rotation of the spine. In the sagittal plain, the monitor should be positioned lower than eye level to avoid neck extension.


Asunto(s)
Ergonomía/métodos , Laparoscopía/métodos , Laparoscopía/normas , Quirófanos/normas , Postura/fisiología , Guías de Práctica Clínica como Asunto , Diseño de Equipo , Humanos , Monitoreo Intraoperatorio/instrumentación , Monitoreo Intraoperatorio/normas , Seguridad/normas
20.
Int J Colorectal Dis ; 23(12): 1199-205, 2008 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18704461

RESUMEN

BACKGROUND AND AIMS: The aim of this study was to investigate sexual function and the presence of lower urinary tract symptoms (LUTS) in male patients with rectal cancer following short-term radiotherapy and laparoscopic total mesorectal excision (LTME) by physical and psychological measurements. MATERIALS AND METHODS: Sexual function and LUTS were assessed by the use of questionnaires [International Index of Erectile Function (IIEF), International Prostate Symptom Score]. Sexual function was further assessed by the use of pharmaco duplex ultrasonography of the cavernous arterial blood flow and nocturnal penile tumescence and rigidity monitoring (NPTR). All investigations were performed prior to the start of preoperative radiotherapy and 15 months after surgery. RESULTS: Nine patients (mean age 60 years) participated. Erectile function was maintained in 71% and ejaculation function in 89%. Compared with pre-operative scores on the IIEF, a significant deterioration in intercourse satisfaction was seen following radiotherapy and LTME (7.9 vs 10.3, p = 0.042), but overall satisfaction remained unchanged (8.0 vs 7.0, p = 0.246). NPTR parameters (duration of erectile episodes, duration of tip rigidity > or =60%) decreased following radiotherapy and LTME. Patients reported a deterioration in micturition frequency (2.0 vs 1.0, p = 0.034) and quality of life due to urinary symptoms (8.0 vs 1.8, p = 0.018). CONCLUSION: Based on these first preliminary findings, data suggest that 15 months after short-term radiotherapy and LTME in men with rectal cancer, objectively assessed sexual dysfunction was considerable, but overall sexual satisfaction had not changed.


Asunto(s)
Laparoscopía , Erección Peniana/fisiología , Recto/cirugía , Fenómenos Fisiológicos del Sistema Urinario , Disfunción Eréctil/etiología , Humanos , Masculino , Persona de Mediana Edad , Pene/diagnóstico por imagen , Complicaciones Posoperatorias , Neoplasias del Recto/cirugía , Encuestas y Cuestionarios , Ultrasonografía Doppler Dúplex , Trastornos Urinarios/etiología
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