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2.
Ann Surg Oncol ; 30(13): 8244-8250, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37782412

RESUMEN

BACKGROUND: Studies have shown minimally invasive esophagectomy (MIE) to be a feasible surgical technique in treating esophageal carcinoma. Postoperative complications have been extensively reviewed, but literature focusing on intraoperative complications is limited. The main objective of this study was to report major intraoperative complications and 90-day mortality during MIE for cancer. METHODS: Data were collected retrospectively from 10 European esophageal surgery centers. All intention-to-treat, minimally invasive laparoscopic/thoracoscopic esophagectomies with gastric conduit reconstruction for esophageal and GE junction cancers operated on between 2003 and 2019 were reviewed. Major intraoperative complications were defined as loss of conduit, erroneous transection of vascular structures, significant injury to other organs including bowel, heart, liver or lung, splenectomy, or other major complications including intubation injuries, arrhythmia, pulmonary embolism, and myocardial infarction. RESULTS: Amongst 2862 MIE cases we identified 98 patients with 101 intraoperative complications. Vascular injuries were the most prevalent, 41 during laparoscopy and 19 during thoracoscopy, with injuries to 18 different vessels. There were 24 splenic vascular or capsular injuries, 11 requiring splenectomies. Four losses of conduit due to gastroepiploic artery injury and six bowel injuries were reported. Eight tracheobronchial lesions needed repair, and 11 patients had significant lung parenchyma injuries. There were 2 on-table deaths. Ninety-day mortality was 9.2%. CONCLUSIONS: This study offers an overview of the range of different intraoperative complications during minimally invasive esophagectomy. Mortality, especially from intrathoracic vascular injuries, appears significant.


Asunto(s)
Neoplasias Esofágicas , Laparoscopía , Lesiones del Sistema Vascular , Humanos , Esofagectomía/efectos adversos , Estudios Retrospectivos , Lesiones del Sistema Vascular/complicaciones , Lesiones del Sistema Vascular/cirugía , Neoplasias Esofágicas/cirugía , Complicaciones Intraoperatorias/etiología , Complicaciones Posoperatorias/etiología , Toracoscopía/métodos , Laparoscopía/métodos , Resultado del Tratamiento , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos
3.
Surg Endosc ; 37(6): 4574-4584, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36849564

RESUMEN

AIM: To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy. METHODS: This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to 'Critical View of Safety' (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points. RESULTS: A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG. CONCLUSION: Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.


Asunto(s)
Sistema Biliar , Colecistectomía Laparoscópica , Humanos , Colecistectomía Laparoscópica/métodos , Verde de Indocianina , Colangiografía/métodos , Conducto Cístico/cirugía
5.
Trials ; 23(1): 809, 2022 Sep 24.
Artículo en Inglés | MEDLINE | ID: mdl-36153559

RESUMEN

BACKGROUND: Prophylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, Surgery 52:205-22, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure. The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C. METHODS/DESIGN: Binational multicenter randomized controlled non-inferiority trial, stratifying patients to high and low risk for POPF grade B/C and incorporating a standardized strategy for pancreatic transection. Two groups of 141 patients (282 in total) undergoing elective DP (either open or minimally invasive, with or without splenectomy). Primary outcome is postoperative rate of morbidity (Clavien-Dindo score ≥ 3), and the most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, postpancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS) (Wente et al., Surgery 142:20-5, 2007), length of stay (LOS), readmission within 90 days, in-hospital mortality, and 90-day mortality. DISCUSSION: PANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications (Wente etal., Surgery 142:20-5, 2007; Bassi et al., Surgery 161:584-91, 2017). Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation (McMillan et al., Surgery 159:1013-22, 2016; Pratt et al., J Gastrointest Surg 10:1264-78, 2006). The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling device (de Pastena et al., Ann Surg 2022; Asbun and Stauffer, Surg Endosc 25:2643-9, 2011).


Asunto(s)
Pancreatectomía , Fístula Pancreática , Abdomen/cirugía , Drenaje/métodos , Humanos , Páncreas/cirugía , Pancreatectomía/efectos adversos , Pancreatectomía/métodos , Fístula Pancreática/etiología , Fístula Pancreática/prevención & control , Fístula Pancreática/cirugía , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/cirugía , Estudios Retrospectivos
6.
Br J Surg ; 108(1): 80-87, 2021 01 27.
Artículo en Inglés | MEDLINE | ID: mdl-33640946

RESUMEN

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) is increasingly being performed because of perceived patient benefits. Whether conversion of MIPD to open pancreatoduodenectomy worsens outcome, and which risk factors are associated with conversion, is unclear. METHODS: This was a post hoc analysis of a European multicentre retrospective cohort study of patients undergoing MIPD (2012-2017) in ten medium-volume (10-19 MIPDs annually) and four high-volume (at least 20 MIPDs annually) centres. Propensity score matching (1 : 1) was used to compare outcomes of converted and non-converted MIPD procedures. Multivariable logistic regression analysis was performed to identify risk factors for conversion, with results presented as odds ratios (ORs) with 95 per cent confidence intervals (c.i). RESULTS: Overall, 65 of 709 MIPDs were converted (9.2 per cent) and the overall 30-day mortality rate was 3.8 per cent. Risk factors for conversion were tumour size larger than 40 mm (OR 2.7, 95 per cent c.i.1.0 to 6.8; P = 0.041), pancreatobiliary tumours (OR 2.2, 1.0 to 4.8; P = 0.039), age at least 75 years (OR 2.0, 1.0 to 4.1; P = 0.043), and laparoscopic pancreatoduodenectomy (OR 5.2, 2.5 to 10.7; P < 0.001). Medium-volume centres had a higher risk of conversion than high-volume centres (15.2 versus 4.1 per cent, P < 0.001; OR 4.1, 2.3 to 7.4, P < 0.001). After propensity score matching (56 converted MIPDs and 56 completed MIPDs) including risk factors, rates of complications with a Clavien-Dindo grade of III or higher (32 versus 34 per cent; P = 0.841) and 30-day mortality (12 versus 6 per cent; P = 0.274) did not differ between converted and non-converted MIPDs. CONCLUSION: Risk factors for conversion during MIPD include age, large tumour size, tumour location, laparoscopic approach, and surgery in medium-volume centres. Although conversion during MIPD itself was not associated with worse outcomes, the outcome in these patients was poor in general which should be taken into account during patient selection for MIPD.


Asunto(s)
Conversión a Cirugía Abierta/estadística & datos numéricos , Laparoscopía/estadística & datos numéricos , Pancreaticoduodenectomía/estadística & datos numéricos , Factores de Edad , Anciano , Conversión a Cirugía Abierta/efectos adversos , Femenino , Humanos , Laparoscopía/efectos adversos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Neoplasias Pancreáticas/patología , Neoplasias Pancreáticas/cirugía , Pancreaticoduodenectomía/efectos adversos , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
7.
Dis Esophagus ; 34(6)2021 Jun 14.
Artículo en Inglés | MEDLINE | ID: mdl-32960264

RESUMEN

There are no internationally recognized criteria available to determine preparedness for hospital discharge after esophagectomy. This study aims to achieve international consensus using Delphi methodology. The expert panel consisted of 40 esophageal surgeons spanning 16 countries and 4 continents. During a 3-round, web-based Delphi process, experts voted for discharge criteria using 5-point Likert scales. Data were analyzed using descriptive statistics. Consensus was reached if agreement was ≥75% in round 3. Consensus was achieved for the following basic criteria: nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube. The patient should have passed flatus and does not require oxygen during mobilization or at rest. Central venous catheters should be removed. Adequate analgesia at rest and during mobilization is achieved using both oral opioid and non-opioid analgesics. All vital signs should be normal unless abnormal preoperatively. Inflammatory parameters should be trending down and close to normal (leucocyte count ≤12G/l and C-reactive protein ≤80 mg/dl). This multinational Delphi survey represents the first expert-led process for consensus criteria to determine 'fit-for-discharge' status after esophagectomy. Results of this Delphi survey may be applied to clinical outcomes research as an objective measure of short-term recovery. Furthermore, standardized endpoints identified through this process may be used in clinical practice to guide decisions regarding patient discharge and may help to reduce the risk of premature discharge or prolonged admission.


Asunto(s)
Esofagectomía , Alta del Paciente , Consenso , Técnica Delphi , Humanos , Encuestas y Cuestionarios
8.
BMC Cancer ; 20(1): 142, 2020 Feb 22.
Artículo en Inglés | MEDLINE | ID: mdl-32087686

RESUMEN

BACKGROUND: Thoracic epidural analgesia is the standard postoperative pain management strategy in esophageal cancer surgery. However, paravertebral block analgesia may achieve comparable pain control while inducing less side effects, which may be beneficial for postoperative recovery. This study primarily aims to compare the postoperative quality of recovery between paravertebral catheter versus thoracic epidural analgesia in patients undergoing minimally invasive esophagectomy. METHODS: This study represents a randomized controlled superiority trial. A total of 192 patients will be randomized in 4 Dutch high-volume centers for esophageal cancer surgery. Patients are eligible for inclusion if they are at least 18 years old, able to provide written informed consent and complete questionnaires in Dutch, scheduled to undergo minimally invasive esophagectomy with two-field lymphadenectomy and an intrathoracic anastomosis, and have no contra-indications to either epidural or paravertebral analgesia. The primary outcome is the quality of postoperative recovery, as measured by the Quality of Recovery-40 (QoR-40) questionnaire on the morning of postoperative day 3. Secondary outcomes include the QoR-40 questionnaire score Area Under the Curve on postoperative days 1-3, the integrated pain and systemic opioid score and patient satisfaction and pain experience according to the International Pain Outcomes (IPO) questionnaire, and cost-effectiveness. Furthermore, the groups will be compared regarding the need for additional rescue medication on postoperative days 0-3, technical failure of the pain treatment, duration of anesthesia, duration of surgery, total postoperative fluid administration day 0-3, postoperative vasopressor and inotrope use, length of urinary catheter use, length of hospital stay, postoperative complications, chronic pain at six months after surgery, and other adverse effects. DISCUSSION: In this study, it is hypothesized that paravertebral analgesia achieves comparable pain control while causing less side-effects such as hypotension when compared to epidural analgesia, leading to shorter postoperative length of stay on a monitored ward and superior quality of recovery. If this hypothesis is confirmed, the results of this study can be used to update the relevant guidelines on postoperative pain management for patients undergoing minimally invasive esophagectomy. TRIAL REGISTRATION: Netherlands Trial Registry, NL8037. Registered 19 September 2019.


Asunto(s)
Analgesia Epidural/métodos , Cateterismo/métodos , Neoplasias Esofágicas/cirugía , Esofagectomía/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Manejo del Dolor/métodos , Dolor Postoperatorio/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Neoplasias Esofágicas/patología , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Bloqueo Nervioso/métodos , Países Bajos , Dimensión del Dolor/métodos , Dolor Postoperatorio/etiología , Dolor Postoperatorio/patología , Periodo Posoperatorio , Resultado del Tratamiento , Adulto Joven
9.
Expert Rev Pharmacoecon Outcomes Res ; 20(2): 193-198, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31190575

RESUMEN

Objective: To assess the quality of life and societal costs of patients prior to colorectal surgery in the Netherlands.Methods: This study is embedded in a previous randomized controlled trial (SANICS II). The quality of life was measured using EQ-5D-5L questionnaires. The iMTA medical consumption questionnaire (iMCQ) and the iMTA productivity costs questionnaire (iPCQ) were used to identify and measure healthcare and productivity costs. Subgroup analyses were performed based on age and gender.Results: A total of 178 patients were included in the cost analysis and a total of 161 patients in the quality of life analysis. The three-month mean societal cost per patient amounted to €3,211 of which €1,459 was due to productivity losses. The mean utility was 0.88 per patient. Gender was an important predictor in quality of life with men scoring significantly higher than women (0.92 versus 0.82) at p < 0.0001.Conclusion: Colorectal cancer represents a high economic burden in the Netherlands. Further research with repeated cost and quality of life measurements would be needed to explore the change over time and the effects of surgery.


Asunto(s)
Neoplasias Colorrectales/economía , Costo de Enfermedad , Costos de la Atención en Salud/estadística & datos numéricos , Calidad de Vida , Anciano , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/terapia , Eficiencia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Factores Sexuales , Encuestas y Cuestionarios
10.
Dis Esophagus ; 33(4)2020 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-31608938

RESUMEN

Delayed gastric conduit emptying (DGCE) after esophagectomy for cancer is associated with adverse outcomes and troubling symptoms. Widely accepted diagnostic criteria and a symptom grading tool for DGCE are missing. This hampers the interpretation and comparison of studies. A modified Delphi process, using repeated web-based questionnaires, combined with live interim group discussions was conducted by 33 experts within the field, from Europe, North America, and Asia. DGCE was divided into early DGCE if present within 14 days of surgery and late if present later than 14 days after surgery. The final criteria for early DGCE, accepted by 25 of 27 (93%) experts, were as follows: >500 mL diurnal nasogastric tube output measured on the morning of postoperative day 5 or later or >100% increased gastric tube width on frontal chest x-ray projection together with the presence of an air-fluid level. The final criteria for late DGCE accepted by 89% of the experts were as follows: the patient should have 'quite a bit' or 'very much' of at least two of the following symptoms; early satiety/fullness, vomiting, nausea, regurgitation or inability to meet caloric need by oral intake and delayed contrast passage on upper gastrointestinal water-soluble contrast radiogram or on timed barium swallow. A symptom grading tool for late DGCE was constructed grading each symptom as: 'not at all', 'a little', 'quite a bit', or 'very much', generating 0, 1, 2, or 3 points, respectively. For the five symptoms retained in the diagnostic criteria for late DGCE, the minimum score would be 0, and the maximum score would be 15. The final symptom grading tool for late DGCE was accepted by 27 of 31 (87%) experts. For the first time, diagnostic criteria for early and late DGCE and a symptom grading tool for late DGCE are available, based on an international expert consensus process.


Asunto(s)
Trastornos de la Motilidad Esofágica/diagnóstico , Neoplasias Esofágicas/cirugía , Esofagectomía/efectos adversos , Complicaciones Posoperatorias/diagnóstico , Evaluación de Síntomas/normas , Adulto , Técnica Delphi , Trastornos de la Motilidad Esofágica/etiología , Femenino , Vaciamiento Gástrico , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento
11.
BMC Cancer ; 19(1): 420, 2019 May 06.
Artículo en Inglés | MEDLINE | ID: mdl-31060544

RESUMEN

BACKGROUND: At present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients. The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy. METHODS: In this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4 cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index < 7) and/or tumour positive peritoneal cytology are confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy was given (prior to inclusion) without disease progression. DISCUSSION: The PERISCOPE II study will determine whether gastric cancer patients with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with systemic chemotherapy, gastrectomy, CRS and HIPEC have a survival benefit over patients treated with palliative systemic chemotherapy only. TRIAL REGISTRATION: clinicaltrials.gov NCT03348150 ; registration date November 2017; first enrolment November 2017; expected end date December 2022; trial status: Ongoing.


Asunto(s)
Procedimientos Quirúrgicos de Citorreducción/métodos , Hipertermia Inducida/métodos , Cuidados Paliativos/métodos , Neoplasias Peritoneales/terapia , Neoplasias Gástricas/terapia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Quimioterapia Adyuvante/economía , Quimioterapia Adyuvante/métodos , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Procedimientos Quirúrgicos de Citorreducción/economía , Supervivencia sin Enfermedad , Femenino , Gastrectomía/economía , Gastrectomía/métodos , Humanos , Hipertermia Inducida/economía , Estimación de Kaplan-Meier , Masculino , Estudios Multicéntricos como Asunto , Países Bajos/epidemiología , Cuidados Paliativos/economía , Neoplasias Peritoneales/economía , Neoplasias Peritoneales/secundario , Peritoneo/patología , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias Gástricas/economía , Neoplasias Gástricas/patología
12.
Br J Surg ; 106(7): 910-921, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-31012498

RESUMEN

BACKGROUND: Minimally invasive distal pancreatectomy decreases time to functional recovery compared with open distal pancreatectomy, but the cost-effectiveness and impact on disease-specific quality of life have yet to be established. METHODS: The LEOPARD trial randomized patients to minimally invasive (robot-assisted or laparoscopic) or open distal pancreatectomy in 14 Dutch centres between April 2015 and March 2017. Use of hospital healthcare resources, complications and disease-specific quality of life were recorded up to 1 year after surgery. Unit costs of hospital healthcare resources were determined, and cost-effectiveness and cost-utility analyses were performed. Primary outcomes were the costs per day earlier functional recovery and per quality-adjusted life-year. RESULTS: All 104 patients who had a distal pancreatectomy (48 minimally invasive and 56 open) in the trial were included in this study. Patients who underwent a robot-assisted procedure were excluded from the cost analysis. Total medical costs were comparable after laparoscopic and open distal pancreatectomy (mean difference €-427 (95 per cent bias-corrected and accelerated confidence interval €-4700 to 3613; P = 0·839). Laparoscopic distal pancreatectomy was shown to have a probability of at least 0·566 of being more cost-effective than the open approach at a willingness-to-pay threshold of €0 per day of earlier recovery, and a probability of 0·676 per additional quality-adjusted life-year at a willingness-to-pay threshold of €80 000. There were no significant differences in cosmetic satisfaction scores (median 9 (i.q.r. 5·75-10) versus 7 (4-8·75); P = 0·056) and disease-specific quality of life after minimally invasive (laparoscopic and robot-assisted procedures) versus open distal pancreatectomy. CONCLUSION: Laparoscopic distal pancreatectomy was at least as cost-effective as open distal pancreatectomy in terms of time to functional recovery and quality-adjusted life-years. Cosmesis and quality of life were similar in the two groups 1 year after surgery.


Asunto(s)
Análisis Costo-Beneficio , Costos de Hospital/estadística & datos numéricos , Laparoscopía/economía , Pancreatectomía/métodos , Calidad de Vida , Procedimientos Quirúrgicos Robotizados/economía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Evaluación de Resultado en la Atención de Salud , Pancreatectomía/economía , Satisfacción del Paciente , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/epidemiología , Años de Vida Ajustados por Calidad de Vida , Recuperación de la Función , Método Simple Ciego
13.
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
14.
Dis Esophagus ; 31(3)2018 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-29121243

RESUMEN

Evidence suggests that structured training programs for laparoscopic procedures can ensure a safe standard of skill acquisition prior to independent practice. Although minimally invasive esophagectomy (MIO) is technically demanding, no consensus on requirements for training for the MIO procedure exists. The aim of this study is to determine essential steps required for a structured training program in MIO using the Delphi consensus methodology. Eighteen MIO experts from 13 European hospitals were asked to participate in this study. The consensus process consisted of two structured meetings with the expert panel, and two Delphi questionnaire rounds. A list of items required for training MIO were constructed for three key domains of MIO, including (1) requisite criteria for units wishing to be trained and (2) to proctor MIO, and (3) a framework of a MIO training program. Items were rated by the experts on a scale 1-5, where 1 signified 'not important' and 5 represented 'very important.' Consensus for each domain was defined as achieving Cronbach alpha ≥0.70. Items were considered as fundamental when ≥75% of experts rated it important (4) or very important (5). Both Delphi rounds were completed by 16 (89%) of the 18 invited experts, with a median experience of 18 years with minimally invasive surgery. Consensus was achieved for all three key domains. Following two rounds of a 107-item questionnaire, 50 items were rated as essential for training MIO. A consensus among European MIO experts on essential items required for training MIO is presented. The identified items can serve as directive principles and core standards for creating a comprehensive training program for MIO.


Asunto(s)
Neoplasias Esofágicas/cirugía , Esofagectomía/educación , Laparoscopía/educación , Enseñanza/normas , Competencia Clínica , Consenso , Técnica Delphi , Esofagectomía/normas , Europa (Continente) , Humanos , Laparoscopía/normas
15.
Dis Esophagus ; 31(1): 1-8, 2018 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-29025081

RESUMEN

A nil-by-mouth regime with enteral nutrition via an artificial route is frequently applied following esophagectomy. However, early initiation of oral feeding could potentially improve recovery and has shown to be beneficial in many types of abdominal surgery. Although short-term nutritional safety of oral intake after an esophagectomy has been documented, long-term effects of this feeding regimen are unknown. In this cohort study, data from patients undergoing minimal invasive Ivor-Lewis esophagectomy between 04-2012 and 09-2015 in three centers in Netherlands were collected. Patients in the oral feeding group were retrieved from a previous prospective study and compared with a cohort of patients with early enteral jejunostomy feeding but delayed oral intake. Body mass index (BMI) measurements, complications, and nutritional re-interventions (re- or start of artificial feeding, start of total parenteral nutrition) were gathered over the course of one year after surgery. One year after surgery the median BMI was 22.8 kg/m2 and weight loss was 7.0 kg (9.5%) in 114 patients. Patients in the early oral feeding group lost more weight during the first postoperative month (P = 0.004). However, in the months thereafter this difference was not observed anymore. In the early oral feeding group, 28 patients (56%) required a nutritional re-intervention, compared to 46 patients (72%) in the delayed oral feeding group (P = 0.078). During admission, more re-interventions were performed in the delayed oral feeding group (17 vs. 46 patients P < 0.001). Esophagectomy reduces BMI in the first year after surgery regardless of the feeding regimen. Direct start of oral intake following esophagectomy has no impact on early nutritional re-interventions and long-term weight loss.


Asunto(s)
Ingestión de Alimentos , Nutrición Enteral/métodos , Neoplasias Esofágicas/cirugía , Esofagectomía , Anciano , Índice de Masa Corporal , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Prospectivos , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Pérdida de Peso
16.
17.
Int J Radiat Oncol Biol Phys ; 97(4): 813-821, 2017 03 15.
Artículo en Inglés | MEDLINE | ID: mdl-28244418

RESUMEN

PURPOSE: To determine, in a large series, the influence of the extent and dose of radiation to the fundus of the stomach and mediastinum on the development and severity of anastomotic complications in patients with esophageal cancer treated with neoadjuvant chemoradiation followed by esophagectomy with cervical anastomosis. METHODS AND MATERIALS: Between 2005 and 2012, 364 consecutive patients with esophageal cancer treated with neoadjuvant chemoradiation (41.4 Gy combined with chemotherapy) followed by esophagectomy were included. The future anastomotic region in the fundus was determined, and the mean dose, V20-V40, and upper planning target volume border in relation to mediastinal length, expressed as the mediastinal ratio, were calculated. RESULTS: Anastomotic leakage occurred in 22% and anastomotic stenosis in 41%. Logistic regression analysis revealed no influence of age, comorbidity, mean fundus dose, V20-V40, or the mediastinal ratio on the incidence of anastomotic leakage or anastomotic stenosis. In 28% of the patients severe complications (Clavien-Dindo score of ≥IIIB) occurred. The presence of multiple comorbidities (hazard ratio 2.4 [95% confidence interval 1.3-4.5], P=.006) and a mediastinal ratio of 0.5 to 1.0 (hazard ratio 1.9 [95% confidence interval 1.0-3.5], P=.036) were both independent predictors of severe complications. CONCLUSION: With a mean radiation dose of 24.2 Gy to the future anastomotic region of the gastric fundus, the radiation dose was not associated with the incidence of anastomotic leakage or anastomotic stenosis. The incidence of severe complications was associated with a high superior mediastinal planning target volume border.


Asunto(s)
Anastomosis Quirúrgica/mortalidad , Quimioradioterapia Adyuvante/mortalidad , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/terapia , Estenosis Esofágica/mortalidad , Esofagectomía/mortalidad , Traumatismos por Radiación/mortalidad , Comorbilidad , Esofagoplastia/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Intubación Gastrointestinal/mortalidad , Masculino , Persona de Mediana Edad , Cuello/cirugía , Terapia Neoadyuvante , Países Bajos/epidemiología , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento
18.
Colorectal Dis ; 19(7): 667-674, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27943617

RESUMEN

AIM: Anastomotic leakage (AL) following abdominal surgery is a critical determinant of postoperative recovery, of which the aetiology is largely unknown. Interestingly, interventions aimed at reducing the inflammatory response and postoperative ileus (POI) have an unexpected effect on AL. The aim of this study was to investigate the relation of POI with inflammation and AL after colorectal resection. METHOD: A post hoc analysis of a prospective randomized controlled trial in which patients underwent a colorectal resection was performed. Patients undergoing a colorectal resection were stratified into having or not having POI. The incidence of AL and other clinical parameters was registered prospectively. Intestinal fatty acid binding protein (I-FABP, a marker for tissue damage) and the inflammatory response in plasma and colon tissue were determined. RESULTS: AL was present in nine of 43 patients in the POI group, and in one of 65 in the group without POI (P < 0.001). There was a significant association between POI and AL (OR 12.57, 95% CI: 2.73-120.65; P = 0.0005). Patients with POI had significantly higher plasma levels of soluble tumour necrosis factor receptor 1 (TNFRSF1A) at 4 h postoperatively (0.89 ng/l, interquartile range 0.56) than patients without POI (0.80 ng/l, interquartile range 0.37; P = 0.04) and higher plasma levels of C-reactive protein on the second day postoperatively (234 ± 77 vs 163 ± 86 mg/l; P = 0.001). Patients who developed AL had significantly higher plasma levels of I-FABP compared with patients without AL at 24 h after onset of surgery. CONCLUSION: POI is associated with a higher prevalence of AL and an increased inflammatory response.


Asunto(s)
Fuga Anastomótica/etiología , Colectomía/efectos adversos , Enfermedades del Colon/etiología , Ileus/etiología , Complicaciones Posoperatorias , Anciano , Fuga Anastomótica/sangre , Fuga Anastomótica/epidemiología , Proteína C-Reactiva/análisis , Enfermedades del Colon/sangre , Enfermedades del Colon/epidemiología , Neoplasias Colorrectales/cirugía , Proteínas de Unión a Ácidos Grasos/análisis , Femenino , Humanos , Ileus/sangre , Ileus/epidemiología , Incidencia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo
19.
Eur J Surg Oncol ; 42(8): 1183-90, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27134188

RESUMEN

BACKGROUND: Patients with resectable oesophageal cancer are treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery within 3-8 weeks. In practice, surgery is often delayed for various reasons. The aim of this study was to evaluate whether delaying surgery beyond 8 weeks has an effect on postoperative morbidity, long-term survival, and pathologic response in patients treated for oesophageal ADC. METHODS: Patients who underwent nCRT followed by surgery, for cT1-3, N0-3, M0 ADC between 2001 and 2014 were retrospectively included from a prospectively obtained database. Patients with a time from the end of nCRT to surgery (TTS) ≤8 weeks were compared with patients with a TTS >8 weeks. RESULTS: Of 190 patients, 65 had a TTS ≤8 weeks, and 125 had a TTS >8 weeks. Patient characteristics were comparable for both groups, but patients with TTS >8 weeks exhibited higher ASA scores (p = 0.013) and more comorbidities (p = 0.007). Multivariate analysis revealed that TTS did not significantly influence postoperative morbidity, pathologic complete response rates, and five-year survival rates (42% in patients with TTS ≤8 weeks and 37% in patients with TTS >8 weeks). CONCLUSIONS: Delaying surgery beyond 8 weeks after nCRT did not significantly influence postoperative morbidity, pathologic response, and survival in patients with non-metastatic ADC. Therefore, it appears reasonable to postpone surgery beyond 8 weeks in patients who have not yet recovered from nCRT. However, if the patient is fit for surgery, postponing surgery does not have any additional advantages.


Asunto(s)
Adenocarcinoma/terapia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia , Neoplasias Esofágicas/terapia , Esofagectomía/métodos , Terapia Neoadyuvante , Complicaciones Posoperatorias/epidemiología , Adenocarcinoma/patología , Anciano , Carboplatino/administración & dosificación , Neoplasias Esofágicas/patología , Femenino , Fluorouracilo/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Paclitaxel/administración & dosificación , Radioterapia Conformacional , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
20.
Hernia ; 20(4): 497-504, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-27193004

RESUMEN

PURPOSE: Umbilical pilonidal sinus (UPS) has an atypical clinical presentation and is therefore not well recognized. The aim of this case series and review of the literature, is to provide more insight in the underlying pathology and a guidance for the treatment of this condition. METHODS: Three recent clinical cases are described that made us perform a multi-database research was to reveal relevant literature. RESULTS: Three relevant clinical cases from our clinic are described. Thirth three studies, describing 463 patients were included. Most studies were case reports or series; few were case series or cohort studies. UPS develops by loose hairs getting caught in the umbilical pit and subsequently penetrate the umbilical cicatrix by friction. In this way an inflammatory response is triggered, resulting in oedema that further narrows the umbilical orifice, hence forming a sinus. Several risk factors are identified. There is no particular consensus on the treatment of this disease. Although older literature advocates immediate umbilical excision without exception, recent studies provide evidence that supports multiple courses of conservative treatment. Several cases were described in which surgery consisted of excision of the sinus and hair tufts in contrast to excision of the entire umbilicus. CONCLUSIONS: Umbilical pilonidal disease has an atypical presentation and might mimic conditions such as incarcerated hernia, Anterior Cutaneous Nerve Entrapment Syndrome or urachal cyst. Risk factors that can bring physicians closer to a reliable diagnosis are identified. An example of a treatment algorithm is provided, suggesting surgery should only be considered when conservative treatment fails.


Asunto(s)
Seno Pilonidal/diagnóstico , Seno Pilonidal/cirugía , Ombligo/cirugía , Adulto , Anciano , Femenino , Cabello , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo
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