Dataset Information

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

ABSTRACT:

Introduction

In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact.

Methods and analysis

The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients.

Ethics and dissemination

The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals.

Trial registration number

NCT02502318.

SUBMITTER: Pages PB

PROVIDER: S-EPMC5541439 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

Pagès Pierre-Benoit PB Abou Hanna Halim H Bertaux Anne-Claire AC Serge Aho Ludwig Serge LS Magdaleinat Pierre P Baste Jean-Marc JM Filaire Marc M de Latour Richard R Assouad Jalal J Tronc François F Jayle Christophe C Mouroux Jérome J Thomas Pascal-Alexandre PA Falcoz Pierre-Emmanuel PE Marty-Ané Charles-Henri CH Bernard Alain A

BMJ open 20170615 6

<h4>Introduction</h4>In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoecon ...[more]

PMID: 28619764

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Project description:IntroductionLung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.Methods and analysisThe VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5?weeks after randomisation (approximately 1?month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1?year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.Ethics and disseminationThis trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.Trial registration numberISRCTN13472721.

Project description:BackgroundOperative safety and oncologic adequacy of thoracoscopic sleeve lobectomy remain controversial. As such, the purpose of this meta-analysis was to evaluate evidence comparing thoracoscopy and thoracotomy in sleeve lobectomy for centrally located non-small cell lung cancer (NSCLC).MethodsElectronic searches of PubMed and Web of Science databases were undertaken from inception to March 2020. Comparative studies about thoracoscopic and thoracotomy sleeve lobectomy, with evaluation for perioperative outcomes and oncological results were identified. The following outcomes were measured in this meta-analysis: operating time, blood loss, numbers of lymph node, postoperative hospital stay, chest drainage time, postoperative complication rate, mortality, overall survival (OS). The standardized difference (SMD), relative risk (RR) and hazard ratio (HR) with 95% confidence intervals (CI) were pooled using Stata software.ResultsSix studies generating 281 thoracoscopy and 369 thoracotomy cases were finally included. There was no significant difference in intraoperative blood loss, number of resected lymph nodes, chest drainage time, postoperative complication rate and mortality between two groups. However, thoracoscopic sleeve lobectomy was associated with longer operation time (SMD 0.59, 95% CI: 0.14 to 1.03, P=0.010). And shorter postoperative hospital stays (SMD -0.24, 95% CI: -0.51 to 0.03, P=0.078) were observed in the thoracoscopy group with marginal significance. Furthermore, sleeve lobectomy via thoracoscopy could achieve comparable OS compared to that via thoracotomy (HR 0.69, 95% CI: 0.38 to 1.00; P<0.001). In addition, there were no evident publication bias in all observational outcomes.ConclusionsCurrent evidence suggests that thoracoscopic sleeve lobectomy is a safe and efficient surgical procedure for centrally located NSCLC, with comparable perioperative outcomes and equivalent oncological results compared to thoracotomy sleeve lobectomy.

Project description:INTRODUCTION:Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring. Antenatal admissions cause a burden to patients as well as hospital resources and costs. A telemonitoring platform connected to wireless cardiotocography (CTG) and automated blood pressure (BP) devices can be used for telemonitoring in pregnancy. Home telemonitoring might improve autonomy and reduce admissions and thus costs. The aim of this study is to compare the effects on patient safety, satisfaction and cost-effectiveness of hospital care versus telemonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring. METHODS AND ANALYSIS:The HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements or an intrauterine fetal death in a previous pregnancy.Randomisation takes place between traditional hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery. Telemonitoring at home is facilitated with Sense4Baby CTG devices, Microlife BP monitor and daily telephone calls with an obstetric healthcare professional as well as weekly hospital visits.Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7?or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate. Patient satisfaction and preference of care will be assessed using validated questionnaires. We will perform an economic analysis. Outcomes will be analysed according to the intention to treat principle. ETHICS AND DISSEMINATION:The study protocol was approved by the Ethics Committee of the Utrecht University Medical Center and the boards of all six participating centres. Trial results will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER:NTR6076.

Project description:IntroductionNumbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice.Methods and analysisUK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery.Ethics and disseminationA favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication.Trial registration numberISRCTN13930454.

Project description:IntroductionDistal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.Methods and analysisTo test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).Ethics and disseminationThe protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.Trial registration numberDutch Trial Registry (NTR), NL6140, protocol V.2.

Dataset Information

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

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