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1.
JAMA Netw Open ; 7(4): e246556, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38639938

RESUMO

Importance: Suboptimal surgical performance is hypothesized to be associated with less favorable patient outcomes in minimally invasive esophagectomy (MIE). Establishing this association may lead to programs that promote better surgical performance of MIE and improve patient outcomes. Objective: To investigate associations between surgical performance and postoperative outcomes after MIE. Design, Setting, and Participants: In this nationwide cohort study of 15 Dutch hospitals that perform more than 20 MIEs per year, 7 masked expert MIE surgeons assessed surgical performance using videos and a previously developed and validated competency assessment tool (CAT). Each hospital submitted 2 representative videos of MIEs performed between November 4, 2021, and September 13, 2022. Patients registered in the Dutch Upper Gastrointestinal Cancer Audit between January 1, 2020, and December 31, 2021, were included to examine patient outcomes. Exposure: Hospitals were divided into quartiles based on their MIE-CAT performance score. Outcomes were compared between highest (top 25%) and lowest (bottom 25%) performing quartiles. Transthoracic MIE with gastric tube reconstruction. Main Outcome and Measure: The primary outcome was severe postoperative complications (Clavien-Dindo ≥3) within 30 days after surgery. Multilevel logistic regression, with clustering of patients within hospitals, was used to analyze associations between performance and outcomes. Results: In total, 30 videos and 970 patients (mean [SD] age, 66.6 [9.1] years; 719 men [74.1%]) were included. The mean (SD) MIE-CAT score was 113.6 (5.5) in the highest performance quartile vs 94.1 (5.9) in the lowest. Severe postoperative complications occurred in 18.7% (41 of 219) of patients in the highest performance quartile vs 39.2% (40 of 102) in the lowest (risk ratio [RR], 0.50; 95% CI, 0.24-0.99). The highest vs the lowest performance quartile showed lower rates of conversions (1.8% vs 8.9%; RR, 0.21; 95% CI, 0.21-0.21), intraoperative complications (2.7% vs 7.8%; RR, 0.21; 95% CI, 0.04-0.94), and overall postoperative complications (46.1% vs 65.7%; RR, 0.54; 95% CI, 0.24-0.96). The R0 resection rate (96.8% vs 94.2%; RR, 1.03; 95% CI, 0.97-1.05) and lymph node yield (mean [SD], 38.9 [14.7] vs 26.2 [9.0]; RR, 3.20; 95% CI, 0.27-3.21) increased with oncologic-specific performance (eg, hiatus dissection, lymph node dissection). In addition, a high anastomotic phase score was associated with a lower anastomotic leakage rate (4.6% vs 17.7%; RR, 0.14; 95% CI, 0.06-0.31). Conclusions and Relevance: These findings suggest that better surgical performance is associated with fewer perioperative complications for patients with esophageal cancer on a national level. If surgical performance of MIE can be improved with MIE-CAT implementation, substantially better patient outcomes may be achievable.


Assuntos
Neoplasias Esofágicas , Esofagectomia , Masculino , Humanos , Idoso , Estudos de Coortes , Resultado do Tratamento , Esofagectomia/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos , Complicações Pós-Operatórias/etiologia , Neoplasias Esofágicas/cirurgia , Neoplasias Esofágicas/complicações
2.
Br J Cancer ; 130(2): 251-259, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38087040

RESUMO

BACKGROUND: In treatment of colon cancer, strict waiting-time targets are enforced, leaving professionals no room to lengthen treatment intervals when advisable, for instance to optimise a patient's health status by means of prehabilitation. Good quality studies supporting these targets are lacking. With this study we aim to establish whether a prolonged treatment interval is associated with a clinically relevant deterioration in overall and cancer free survival. METHODS: This retrospective multicenter non-inferiority study includes all consecutive patients who underwent elective oncological resection of a biopsy-proven primary non-metastatic colon carcinoma between 2010 and 2016 in six hospitals in the Southern Netherlands. Treatment interval was defined as time between diagnosis and surgical treatment. Cut-off points for treatment interval were ≤35 days and ≤49 days. FINDINGS: 3376 patients were included. Cancer recurred in 505 patients (15.0%) For cancer free survival, a treatment interval >35 days and >49 days was non-inferior to a treatment interval ≤35 days. Results for overall survival were inconclusive, but no association was found. CONCLUSION: For cancer free survival, a prolonged treatment interval, even over 49 days, is non-inferior to the currently set waiting-time target of ≤35 days. Therefore, the waiting-time targets set as fundamental objective in current treatment guidelines should become directional instead of strict targets.


Assuntos
Neoplasias do Colo , Recidiva Local de Neoplasia , Humanos , Neoplasias do Colo/cirurgia , Países Baixos/epidemiologia , Estudos Retrospectivos
3.
Br J Surg ; 111(1)2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38103184

RESUMO

BACKGROUND: Substantial variation exists when performing a minimally invasive right hemicolectomy (MIRH) due to disparities in training, expertise and differences in implementation of innovations. This study aimed to achieve national consensus on an optimal and standardized MIRH technique for colon cancer and to develop and validate a video-based competency assessment tool (CAT) for MIRH. METHOD: Statements covering all elements of MIRH were formulated. Subsequently, the Delphi technique was used to reach consensus on a standardized MIRH among 76 colorectal surgeons from 43 different centres. A CAT was developed based on the Delphi results. Nine surgeons assessed the same 12 unedited full-length videos using the CAT, allowing evaluation of the intraclass correlation coefficient (ICC). RESULTS: After three Delphi rounds, consensus (≥80% agreement) was achieved on 23 of the 24 statements. Consensus statements included the use of low intra-abdominal pressure, detailed anatomical outline how to perform complete mesocolic excision with central vascular ligation, the creation of an intracorporeal anastomosis, and specimen extraction through a Pfannenstiel incision using a wound protector. The CAT included seven consecutive steps to measure competency of the MIRH and showed high consistency among surgeons with an overall ICC of 0.923. CONCLUSION: Nationwide consensus on a standardized and optimized technique of MIRH was reached. The CAT developed showed excellent interrater reliability. These achievements are crucial steps to an ongoing nationwide quality improvement project (the Right study).


Assuntos
Neoplasias do Colo , Laparoscopia , Cirurgiões , Humanos , Reprodutibilidade dos Testes , Neoplasias do Colo/cirurgia , Colectomia/métodos , Padrões de Referência , Laparoscopia/métodos , Técnica Delphi
4.
BMJ Open ; 13(7): e067981, 2023 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-37407040

RESUMO

INTRODUCTION: Oesophageal cancer (EC) and gastric cancer (GC) are among the top 10 cancers worldwide. Both diseases impact the nutritional status of patients and their Quality of Life (QoL). Preoperative malnutrition is reported in 42%-80%. However, studies investigating postoperative nutritional status are limited, and postoperative identification and treatment of micronutrient and macronutrient deficiencies are currently lacking in (inter-)national guidelines. The aim of this study is to identify and target micronutrient deficiencies after surgery for oesophagogastric neoplasms. METHODS: This is a single-centre prospective intervention trial performed in Zuyderland Medical Centre. 248 patients who underwent oesophagectomy (n=124) or (sub)total gastrectomy (n=124) from 2011 until 2022 will be included. Both groups will receive Calcium Soft Chew D3 and a multivitamin supplement (MVS) specifically developed according to the type of operation patients underwent; the oesophagectomy group will receive Multi-E and the gastrectomy group will receive Multi-G. The MVSs will be taken once daily and Calcium Soft Chew D3 two times per day. Supplementation will start after baseline measurements. At baseline (T0), blood withdrawal for micronutrient analysis and faecal elastase-1 analysis for exocrine pancreatic insufficiency (EPI) will be performed. Additionally, patients will receive questionnaires regarding QoL and dietary behaviour. After 180 days of supplementation (T1), baseline measurements will be repeated, and the supplement tolerance questionnaire will be completed. Measurements will also be conducted after 360 days (T2) and after 720 days (T3) of supplementation. The main study parameter is micronutrient deficiency (yes/no) for all measurements. Secondary parameters include occurrence of EPI (n, %), diarrhoea (n, %), steatorrhoea (n, %) or bloating (n, %), time between surgery and start of supplementation (mean in months), and QoL at all time points. ETHICS AND DISSEMINATION: The study was approved by the Zuyderland Medical Centre Ethics Committee, Heerlen, the Netherlands. The findings will be disseminated through scientific congresses and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05281380.


Assuntos
Neoplasias Esofágicas , Vitaminas , Humanos , Vitaminas/uso terapêutico , Qualidade de Vida , Estudos Prospectivos , Cálcio , Cálcio da Dieta , Neoplasias Esofágicas/cirurgia
5.
Acta Chir Belg ; 123(4): 369-374, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35020548

RESUMO

BACKGROUND: Spontaneous esophageal perforation or Boerhaave syndrome is a life-threatening emergency, associated with significant morbidity and mortality. In this retrospective series we describe our single-center experience with a hybrid minimally invasive treatment approach for the treatment of Boerhaave syndrome. METHODS: Clinical data of all patients who presented with spontaneous esophageal rupture between January 2009 and December 2019 were analyzed. All patients underwent esophageal endoscopic stenting to seal the perforation and debridement of the contaminated mediastinal and pleural cavity through video-assisted thoracoscopic surgery (VATS). Primary outcome measure was defined as in-hospital death and 30-day mortality. RESULTS: Twelve patients were included with a median age of 63 years (interquartile range [IQR] 51-74 years) of whom 58% (n = 7) were male. The median Pittsburg perforation severity score was 6.5 (IQR 6-9). Endoscopic reintervention was required in 8 patients (67%), primarily due to stent dislocation. In addition, 5 patients (42%) required re-VATS due to empyema formation. Thirty-day mortality and in-hospital mortality were respectively 17% (n = 2) and 25% (n = 3). CONCLUSION: Endoscopic stenting in combination with thoracoscopic debridement is an effective and safe minimally invasive hybrid approach for the treatment of Boerhaave syndrome. This is depicted by the relatively low mortality rates, even among patients with high perforation severity scores. The relatively low mortality rates may be attributed to the combined approach of rapidly sealing the defect and decontamination of the thorax. Future studies should aim to corroborate this evidence which is limited by its sample size and retrospective nature.


Assuntos
Perfuração Esofágica , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Perfuração Esofágica/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Mortalidade Hospitalar , Stents
6.
BMC Cancer ; 22(1): 109, 2022 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-35078438

RESUMO

BACKGROUND: Older cancer patients may search for health information online to prepare for their consultations. However, seeking information online can have negative effects, for instance increased anxiety due to finding incorrect or unclear information. In addition, existing online cancer information is not necessarily adapted to the needs of older patients, even though cancer is a disease often found in older individuals. OBJECTIVE: The aim of this study was to systematically develop, implement and evaluate an online health information tool for older cancer patients, the Patient Navigator, providing information that complements the consultation with healthcare providers. METHOD: For the development and evaluation of the Patient Navigator, the four phases of the MRC framework were used. In the first and second phase the Patient Navigator was developed and pilot tested based on previous research and sub-studies. During the third phase the Patient Navigator was implemented in four Dutch hospitals. In the last phase, a pilot RCT was conducted to evaluate the Patient Navigator in terms of usage (observational tracking data), user experience (self-reported satisfaction, involvement, cognitive load, active control, perceived relevance of the tool), patient participation (observational data during consultation), and patient outcomes related to the consultation (questionnaire data regarding anxiety, satisfaction, and information recall). Recently diagnosed colorectal cancer patients (N = 45) were randomly assigned to the control condition (usual care) or the experimental condition (usual care + Patient Navigator). RESULTS: The Patient Navigator was well used and evaluated positively. Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition. CONCLUSION: Since the Patient Navigator was evaluated positively and decreased anxiety after the consultation, this tool is potentially a valuable addition to the consultation for patients. Usage of the Patient Navigator resulted in patients using less words during consultations, without impairing patients' satisfaction, possibly because information needs might be fulfilled by usage of the Patient Navigator. This could create the possibility to personalize communication during consultations and respond to other patient needs.


Assuntos
Neoplasias Colorretais , Informação de Saúde ao Consumidor/métodos , Sistemas On-Line , Navegação de Pacientes/métodos , Participação do Paciente/estatística & dados numéricos , Idoso , Feminino , Humanos , Masculino , Participação do Paciente/psicologia , Satisfação do Paciente/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos
7.
J Med Internet Res ; 23(7): e23670, 2021 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-34255657

RESUMO

BACKGROUND: Today, many cancer patients engage in online health information seeking (OHIS). However, little is known about how patients differ in their OHIS levels. In addition, OHIS might influence patient participation during a consultation with a physician, which might mediate the effects on patient outcomes. OBJECTIVE: The aim of this study is twofold: first, to provide insight into which personal characteristics and psychosocial factors affect patients' OHIS levels and, second, to test the hypothesis that the effects of OHIS on patient outcomes are mediated by patient participation during the consultation. METHODS: Patient participation was operationalized in terms of patients' absolute word count; the relative contribution of the patient, compared with the health care provider; and the number of questions and assertions expressed during the consultation. The patient outcomes measured were anxiety after the consultation, satisfaction with the consultation, and information recall. Participants in this study were patients recently diagnosed with colorectal cancer recruited from 6 hospitals in the Netherlands (n=90). Data were collected using questionnaires and audio-recorded consultations of patients with health care providers before their surgery. RESULTS: The results showed that younger patients, higher educated patients, patients with a monitoring coping style, and patients who experienced more cancer-related stress engaged more in OHIS. In turn, OHIS was related to patient participation in terms of the patient's absolute word count but not to the relative contribution to the consultation or expressing questions and assertions. We did not find a relation between OHIS and anxiety and OHIS and recall mediated by patient participation. However, we found that patients' absolute word count significantly mediated the positive association between OHIS and patients' satisfaction with the consultation. CONCLUSIONS: Results indicate positive implications of OHIS for patients' care experience and, therefore, the importance of helping patients engage in OHIS. However, the results also suggest that OHIS is only successful in increasing a single aspect of patient participation, which might explain the absence of relations with anxiety and recall. The results suggest that more beneficial effects on patient outcomes may be achieved when health care providers support patients in OHIS.


Assuntos
Comportamento de Busca de Informação , Satisfação Pessoal , Ansiedade , Comunicação , Humanos , Participação do Paciente , Satisfação do Paciente , Relações Médico-Paciente , Encaminhamento e Consulta
9.
Lancet Gastroenterol Hepatol ; 2(1): 13-22, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-28404008

RESUMO

BACKGROUND: Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomised trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. METHODS: We did an open-label, multicentre, randomised controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18-75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomisation system, stratified by type of disease and centre, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was health-related quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomisation group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. FINDINGS: Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n=53) or conservative management (n=56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months' follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114·4 [SD 22·3]) than conservative management (100·4 [22·7]; mean difference 14·2, 95% CI 7·2-21·1, p<0·0001). 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs 23 [40%] of 57 patients in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. INTERPRETATION: Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.


Assuntos
Colo Sigmoide/cirurgia , Tratamento Conservador , Doença Diverticular do Colo/terapia , Adolescente , Adulto , Idoso , Fístula Anastomótica , Doença Diverticular do Colo/cirurgia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Laparoscopia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Recidiva , Fatores de Risco , Resultado do Tratamento , Adulto Jovem
10.
J Natl Cancer Inst ; 108(12)2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27509881

RESUMO

BACKGROUND: The aim of this study was to establish the oncological and functional results of organ preservation with a watch-and-wait approach (W&W) and selective transanal endoscopic microsurgery (TEM) in patients with a clinical complete or near-complete response (cCR) after neoadjuvant chemoradiation for rectal cancer. METHODS: Between 2004 and 2014, organ preservation was offered if response assessment with digital rectal examination, endoscopy, and MRI showed (near) cCR. Watch-and-wait was offered for cCR, and two options were offered for near cCR: TEM or reassessment after three months. Follow-up included endoscopy and MRIs every three months during the first year, and every six months thereafter. Long-term outcome was assessed with Kaplan-Meier curves. Functional outcome was assessed with colostomy-free survival and Vaizey incontinence score (0 = perfect continence, 24 = totally incontinent). RESULTS: One hundred patients were included, with median follow-up of 41.1 months. Sixty-one had cCR at initial response assessment. Thirty-nine had near cCR, of whom 24 developed cCR at the second assessment and 15 patients underwent TEM (9 ypT0, 1 ypT1, 5 ypT2). Fifteen patients developed a local regrowth (12 luminal, 3 nodal), all salvageable and within 25 months. Five patients developed metastases, and five patients died. Three-year overall survival was 96.6% (95% confidence interval [CI] = 89.9% to 98.9%), distant metastasis-free survival was 96.8% (95% CI = 90.4% to 99.0%), local regrowth-free survival was 84.6% (95% CI = 75.8% to 90.5%), and disease-free survival was 80.6% (95% CI = 70.9% to 87.4%). Colostomy-free survival was 94.8% (95% CI = 88.0% to 97.8%), with a good continence after watch-and-wait (Vaizey = 3.4, SD = 3.9) and moderate after TEM (Vaizey = 9.7, SD = 5.1). CONCLUSIONS: Organ preservation appears oncologically safe for selected rectal cancer patients with a cCR or near cCR after neoadjuvant chemoradiation when applying strict selection criteria and frequent follow-up, including endoscopy and MRI. The low colostomy rate and the good long-term functional outcome warrant discussing this option with the patient as an alternative to major surgery.


Assuntos
Quimiorradioterapia Adjuvante , Terapia Neoadjuvante , Recidiva Local de Neoplasia/diagnóstico por imagem , Tratamentos com Preservação do Órgão , Neoplasias Retais/terapia , Idoso , Colostomia , Exame Retal Digital , Intervalo Livre de Doença , Endoscopia Gastrointestinal , Feminino , Seguimentos , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Neoplasias Retais/diagnóstico por imagem , Neoplasias Retais/patologia , Taxa de Sobrevida , Fatores de Tempo , Microcirurgia Endoscópica Transanal , Resultado do Tratamento , Conduta Expectante
11.
Radiother Oncol ; 116(2): 214-20, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26253949

RESUMO

PURPOSE: This phase I/II study sought to determine the safety and maximum tolerated dose (MTD) of the combination of rapamycin, an mTOR inhibitor, with short-course radiotherapy in rectal cancer patients. Antitumor activity, changes in metabolic activity and perfusion on imaging, and changes in phosphorylation status of the mTOR pathway were also assessed. MATERIALS AND METHODS: Patients with primary resectable rectal cancer were treated with short-course hypofractionated radiotherapy (5×5 Gy) combined with oral rapamycin 1 week before and during radiotherapy, followed by surgical resection. RESULTS: Thirteen patients were entered in phase I. One patient developed a dose-limiting toxicity, consisting of a grade 4 leak and grade 4 bleeding. Because of an unexpected high rate of grade 3 postoperative toxicity, it was decided to treat patients with delayed surgery in phase II. Primary endpoint for phase II was tumor blood flow (K(trans)) assessed by perfusion CT. Thirty-one patients were treated with the MTD of 6 mg rapamycin daily. One patient (3%) developed a pathological complete response (pCR) and 3 patients (10%) had a ypT1N0 tumor at the time of resection. No change in tumor perfusion was observed on perfusion CT, but a significant decrease of metabolic activity was found on PET-scan. CONCLUSIONS: The combination of short-course radiotherapy and rapamycin turned out to be feasible, provided that the interval between neo-adjuvant treatment and surgical resection is at least 6 weeks. Although from this cohort no clear increase in pCR could be observed, a clear metabolic response after rapamycin run-in was observed, indicating a biological activity of this drug in rectal cancer.


Assuntos
Antibióticos Antineoplásicos/administração & dosagem , Quimiorradioterapia/métodos , Neoplasias Retais/terapia , Sirolimo/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibióticos Antineoplásicos/efeitos adversos , Feminino , Humanos , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Sirolimo/efeitos adversos , Resultado do Tratamento
12.
Lancet ; 386(10000): 1269-1277, 2015 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-26209030

RESUMO

BACKGROUND: Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. METHODS: We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). INTERPRETATION: Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.


Assuntos
Colo Sigmoide/cirurgia , Doença Diverticular do Colo/cirurgia , Perfuração Intestinal/cirurgia , Lavagem Peritoneal , Peritonite/cirurgia , Doença Diverticular do Colo/complicações , Doença Diverticular do Colo/terapia , Feminino , Humanos , Perfuração Intestinal/etiologia , Laparoscopia , Masculino , Pessoa de Meia-Idade , Peritonite/etiologia , Resultado do Tratamento
13.
Eur J Nucl Med Mol Imaging ; 40(10): 1500-6, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23764889

RESUMO

PURPOSE: Neoadjuvant chemoradiotherapy is increasingly used in oesophageal cancer patients. In general, small tumours are associated with a survival benefit compared to large tumours. Little is known, however, about the relationship between initial tumour volume and response to chemoradiotherapy. Therefore, the aim of this study was to determine whether the pretherapy metabolic tumour volume (MTV) on diagnostic PET/CT in oesophageal cancer patients is correlated with response to chemoradiotherapy in the resection specimen. METHODS: A consecutive series of patients underwent diagnostic PET/CT scanning prior to chemoradiotherapy and oesophagectomy. MTVs were determined on PET/CT and an automated tumour contour was generated using specified standard uptake value thresholds. Response to chemoradiotherapy was determined in the resection specimen according to the scoring system developed by Mandard et al. Patients were divided into different groups according to response to chemoradiotherapy. RESULTS: Between January 2008 and May 2011 a total of 115 patients underwent an oesophagectomy. The MTV determined on diagnostic PET/CT scans was available in 79 patients. Of these 79 patients, 30 (38 %) showed no residual tumour cells at the location of the primary tumour. Three of these patients presented with residual tumour cells in the lymph nodes; 27 patients (34 %) had a complete pathological response. There was a trend towards a better response in patients with a smaller MTV (p = 0.084). CONCLUSION: This study demonstrated a trend towards a correlation between response to chemoradiotherapy in oesophageal cancer patients and smaller MTVs as determined on diagnostic PET/CT prior to neoadjuvant chemoradiotherapy. However, tumour volumes overlapped between groups, indicating the need for multifactorial parameters as predictors. In addition, a complete local tumour response may be accompanied by residual disease in the regional lymph nodes.


Assuntos
Carcinoma/diagnóstico por imagem , Quimiorradioterapia , Neoplasias Esofágicas/diagnóstico por imagem , Terapia Neoadjuvante , Tomografia por Emissão de Pósitrons , Tomografia Computadorizada por Raios X , Adulto , Idoso , Carcinoma/patologia , Carcinoma/terapia , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Imagem Multimodal , Valor Preditivo dos Testes , Resultado do Tratamento
14.
Eur J Cardiothorac Surg ; 39(4): 575-8, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-20833554

RESUMO

OBJECTIVE: Chest tubes induce morbidity such as pain, decrease mobility, increase the risk of infection, and prolong the length of hospital stays. This study evaluates a chest-tube protocol containing a high-drainage threshold and a short time period of drainage. METHODS: A retrospective study was performed with data collected from all elective complete video-assisted thoracoscopic (c-VATS) (bi-)lobectomies between March 2006 and December 2009. All patients had one chest-tube, postoperatively. The chest tube was removed if there was no air leakage and there was a drainage volume of 400 ml (24 h)(-1) or less. We aimed to remove the chest tube on postoperative day 1. RESULTS: This series consists of 110 lobectomies and six bilobectomies. The median duration of chest-tube placement was 1.0 day. In 58.8% of patients (confidence interval (CI) 95%: 49.5-68.0), the drain was removed within 24 h of operation and in 82.5% (CI 95%: 74.2-88.7) within 48 h. In six (6.2%) patients, subcutaneous emphysema developed while the drain was still in place, and was treated with removal of the drain. Persistent air leakage was seen in four (3.4%) patients. One (0.9%) persisting pneumothorax was diagnosed. A pneumothorax after removal of the drain was not diagnosed. No major complications developed in 98 patients (84.5%). The median day of discharge was postoperative day 4. CONCLUSIONS: This study shows it is safe, after c-VATS (bi-)lobectomy, to remove the chest tube within 24 h in 58.8%, and within 48 h in 82.5% of patients. As was also shown in other studies, this leads to shorter length of hospital stays, lower costs, and most importantly, reduces patient morbidity without the added risk of complications.


Assuntos
Tubos Torácicos , Remoção de Dispositivo , Neoplasias Pulmonares/cirurgia , Complicações Pós-Operatórias/etiologia , Cirurgia Torácica Vídeoassistida/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
15.
BMC Surg ; 10: 25, 2010 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-20691040

RESUMO

BACKGROUND: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. METHODS/DESIGN: The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. DISCUSSION: Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. TRIAL REGISTRATION: (Trial register number: NTR1478).


Assuntos
Doença Diverticular do Colo/cirurgia , Doença Diverticular do Colo/terapia , Adolescente , Adulto , Idoso , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Recidiva , Resultado do Tratamento , Conduta Expectante , Adulto Jovem
16.
Interact Cardiovasc Thorac Surg ; 11(4): 512-4, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20656799

RESUMO

The surgical resection of sulcus superior tumors, also referred to as Pancoast tumors, remains a challenging surgical procedure. A patient presented with a superior sulcus tumor situated anterior in the thoracic inlet. The tumor was resected through a transmanubrial approach of Grunenwald combined with a video-assisted thoracic surgery (VATS) lobectomy. VATS can be very helpful in determining the exact location of the resection and at the same time performing a lobectomy avoiding extra morbidity due to a classical thoracotomy.


Assuntos
Neoplasias Pulmonares/cirurgia , Pneumonectomia , Cirurgia Torácica Vídeoassistida , Terapia Combinada , Feminino , Humanos , Neoplasias Pulmonares/terapia , Manúbrio/cirurgia , Pessoa de Meia-Idade
17.
Interact Cardiovasc Thorac Surg ; 10(2): 176-80, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19850598

RESUMO

Data regarding the benefits for the complete video-assisted thoracic surgery (c-VATS) lobectomy over the open lobectomy are numerous. This article describes the experience of introducing this technique in a training hospital, the first reported cohort in The Netherlands. From March 2006 to November 2008, all patients operated on for proven or suspected lung cancer were analyzed. Prospective data from these patients were evaluated. A subgroup analysis for the c-VATS lobectomy is presented. A total of 184 operations were performed on 172 patients. In 122 (66.3%) of the operations the resection ended in a lobectomy of which 70 were done by complete thoracoscopic procedure. For the c-VATS lobectomy the mean operating time was 179 min, with a mean blood loss of 444 ml. The median hospital stay was four days. Complications were present in 10% of c-VATS lobectomies. No mortality was seen in the c-VATS group. After thorough evaluation and training, c-VATS lobectomy is a safe procedure that can be performed in a relatively low volume hospital. It has exceptional short-term benefits. For training purposes all operations must start thoracoscopically. All patients must be operated according the intention to treat method.


Assuntos
Competência Clínica , Educação de Pós-Graduação em Medicina , Neoplasias Pulmonares/cirurgia , Pneumonectomia/métodos , Cirurgia Torácica Vídeoassistida , Adulto , Idoso , Idoso de 80 Anos ou mais , Perda Sanguínea Cirúrgica , Feminino , Humanos , Aprendizagem , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Países Baixos , Seleção de Pacientes , Pneumonectomia/efeitos adversos , Pneumonectomia/educação , Pneumonectomia/mortalidade , Hemorragia Pós-Operatória/etiologia , Estudos Prospectivos , Cirurgia Torácica Vídeoassistida/efeitos adversos , Cirurgia Torácica Vídeoassistida/educação , Cirurgia Torácica Vídeoassistida/mortalidade , Fatores de Tempo , Resultado do Tratamento
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