Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

Abstract Background The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5–30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely. Methods The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants’ health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed. Discussion This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia. Trial registration ClinicalTrials.govNCT03623893. Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018

Download Full-text

Analgesic sparing effect of dexamethasone with levobupivacaine in quadratus lumborum block in patients undergoing unilateral inguinal hernia repair: A prospective randomised controlled trial

Indian Journal of Anaesthesia ◽

10.4103/ija.ija_159_20 ◽

2020 ◽

Vol 64 (8) ◽

pp. 668

Author(s):

Geeta Singariya ◽

Sangeeta Choudhary ◽

Manoj Kamal ◽

SatyaNarayan Seervi ◽

Pooja Bihani ◽

...

Keyword(s):

Inguinal Hernia ◽

Randomised Controlled Trial ◽

Hernia Repair ◽

Inguinal Hernia Repair ◽

Controlled Trial ◽

Unilateral Inguinal Hernia ◽

Quadratus Lumborum Block ◽

Quadratus Lumborum ◽

Sparing Effect ◽

Randomised Controlled

Download Full-text

Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial

BMJ Open ◽

10.1136/bmjopen-2016-014849 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014849 ◽

Cited By ~ 1

Author(s):

Zahidul Quayyum ◽

Andrew Briggs ◽

Jose Robles-Zurita ◽

Keith Oldroyd ◽

Uwe Zeymer ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Cardiogenic Shock ◽

Controlled Trial ◽

Culprit Lesion ◽

Link Type ◽

Trial Analysis ◽

Life Years ◽

Randomised Controlled

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

Download Full-text

Preventive Analgesic Efficacy of Intravenous Tramadol Versus Intravenous Nalbuphine for Elective Inguinal Hernia Repair Surgeries :Randomised Controlled Trial

Indian Journal of Anaesthesia and Analgesia ◽

10.21088/ijaa.2349.8471.4317.13 ◽

2017 ◽

Vol 4 (3 (part-1)) ◽

pp. 629-634

Author(s):

Bhavani Vaidiyanathan ◽

◽

Deepak Paulose Thattayathu ◽

Sangeeta Dhanger ◽

Irudhaya Joseph Raajesh ◽

...

Keyword(s):

Inguinal Hernia ◽

Randomised Controlled Trial ◽

Hernia Repair ◽

Inguinal Hernia Repair ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Randomised Controlled

Download Full-text

Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017511 ◽

2018 ◽

Vol 8 (8) ◽

pp. e017511 ◽

Cited By ~ 1

Author(s):

Nishma Patel ◽

Rebecca J Beeken ◽

Baptiste Leurent ◽

Rumana Z Omar ◽

Irwin Nazareth ◽

...

Keyword(s):

General Practice ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Health Service ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

The Mean ◽

Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

Download Full-text