Kirsty McCormack

Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: a systematic review

Background: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach, and questions remain about their relative merits and risks.Methods: Electronic databases were searched to identify reports of trials comparing laparoscopic TAPP with laparoscopic TEP. In addition, selected conference proceedings were hand-searched, websites consulted, reference lists of all included papers were scanned, and experts contacted for other potentially eligible reports. All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Large non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and serious adverse events. Two reviewers independently extracted data and assessed study quality. Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI).Results: The search identified one RCT which reported no statistically significant difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activities, and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified.Conclusions: There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately-powered randomised controlled trials (RCTs), which compare the different methods of laparoscopic repair.

The Knee Arthroplasty Trial (KAT) design features, baseline characteristics, and two-year functional outcomes after alternative approaches to knee replacement.

BACKGROUND The aim of continued development of total knee replacement systems has been the further improvement of the quality of life and increasing the duration of prosthetic survival. Our goal was to evaluate the effects of several design features, including metal backing of the tibial component, patellar resurfacing, and a mobile bearing between the tibial and femoral components, on the function and survival of the implant. METHODS A pragmatic, multicenter, randomized, controlled trial involving 116 surgeons in thirty-four centers in the United Kingdom was performed; 2352 participants were randomly allocated to be treated with or without a metal backing of the tibial component (409), with or without patellar resurfacing (1715), and/or with or without a mobile bearing (539). Randomization to more than one comparison was allowed. The primary outcome measures were the Oxford Knee Score (OKS), Short Form-12, EuroQol-5D, and the need for additional surgery. The results up to two years postoperatively are reported. RESULTS Functional status and quality-of-life scores were low at baseline but improved markedly across all trial groups following knee replacement (mean overall OKS, 17.98 points at baseline and 34.82 points at two years). Most of the change was observed at three months after the surgery. Six percent of the patients had additional knee surgery within two years. There was no evidence of differences in clinical, functional, or quality-of-life measures between the randomized groups at two years. CONCLUSIONS Patients have substantial improvement following total knee replacement. This is the first adequately powered randomized controlled trial, of which we are aware, in which the effects of metal backing, patellar resurfacing, and a mobile bearing were investigated. We found no evidence of an effect of these variants on the rate of early complications or on functional recovery up to two years after total knee replacement.

Systematic Review of the Agreement of Tonometers with Goldmann Applanation Tonometry

OBJECTIVE To assess the agreement of tonometers available for clinical practice with the Goldmann applanation tonometer (GAT), the most commonly accepted reference device. DESIGN A systematic review and meta-analysis of directly comparative studies assessing the agreement of 1 or more tonometers with the reference tonometer (GAT). PARTICIPANTS A total of 11 582 participants (15 525 eyes) were included. METHODS Summary 95% limits of agreement (LoA) were produced for each comparison. MAIN OUTCOME MEASURES Agreement, recordability, and reliability. RESULTS A total of 102 studies, including 130 paired comparisons, were included, representing 8 tonometers: dynamic contour tonometer, noncontact tonometer (NCT), ocular response analyzer, Ocuton S, handheld applanation tonometer (HAT), rebound tonometer, transpalpebral tonometer, and Tono-Pen. The agreement (95% limits) seemed to vary across tonometers: 0.2 mmHg (-3.8 to 4.3 mmHg) for the NCT to 2.7 mmHg (-4.1 to 9.6 mmHg) for the Ocuton S. The estimated proportion within 2 mmHg of the GAT ranged from 33% (Ocuton S) to 66% and 59% (NCT and HAT, respectively). Substantial inter- and intraobserver variability were observed for all tonometers. CONCLUSIONS The NCT and HAT seem to achieve a measurement closest to the GAT. However, there was substantial variability in measurements both within and between studies.

Cost effectiveness of tension-free vaginal tape for the surgical management of female stress incontinence

OBJECTIVES Stress urinary incontinence affects between 10 percent and 50 percent of women. Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management. Tension-free vaginal tape (TVT) is a newer, minimal access surgical sling procedure, which is being increasingly adopted worldwide. The cost-effectiveness of TVT in comparison with other surgical procedures, particularly open colposuspension, is assessed. METHODS Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures (open and laparoscopic colposuspension, traditional slings, and injectables). Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective. Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT, cure rates for retreatment open colposuspension, and proportions of women who choose retreatment. RESULTS Reliable estimates of relative effectiveness were difficult to derive because the few randomized controlled comparisons had not been optimally analyzed or fully reported. Results of the economic model suggested that TVT dominates open colposuspension (lower cost and same quality of life years [QALYs]) within 5 years after surgery. Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs. TVTs dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension. CONCLUSIONS Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years. There is a need for longer-term follow-up data from methodologically rigorous randomized trials to provide a sounder basis for estimating the relative benefits and cost implications.

The effectiveness of metal on metal hip resurfacing: a systematic review of the available evidence published before 2002

BackgroundConventional total hip replacement (THR) may be felt to carry too high a risk of failure over a patients lifetime, especially in young people. There is increasing interest in metal on metal hip resurfacing arthroplasty (MoM) as this offers a bone-conserving option for treating those patients who are not considered eligible for THR. We aim to evaluate the effectiveness of MoM for treatment of hip disease, and compare it with alternative treatments for hip disease offered within the UK.MethodsA systematic review was carried out to identify the relevant literature on MoM published before 2002. As watchful waiting and total hip replacement are alternative methods commonly used to alleviate the symptoms of degenerative joint disease of the hip, we compared MoM with these.ResultsThe data on the effectiveness of MoM are scarce, as it is a relatively new technique and at present only short-term results are available.ConclusionIt is not possible to make any firm conclusions about the effectiveness of MoM based on these early results. While the short-term results are promising, it is unclear if such results would be replicated in more rigorous studies, and what the long-term performance might be. Further research is needed which ideally should involve long-term randomised comparisons of MoM with alternative approaches to the clinical management of hip disease.

Cost-effectiveness of alternative methods of surgical repair of inguinal hernia

OBJECTIVES To assess the relative cost-effectiveness of laparoscopic methods of inguinal hernia repair compared with open flat mesh and open non-mesh repair. METHODS Data on the effectiveness of these alternatives came from three systematic reviews comparing: (i) laparoscopic methods with open flat mesh or non-mesh methods; (ii) open flat mesh with open non-mesh repair; and (iii) methods that used synthetic mesh to repair the hernia defect with those that did not. Data on costs were obtained from the authors of economic evaluations previously conducted alongside trials included in the reviews. A Markov model was used to model cost-effectiveness for a five-year period after the initial operation. The outcomes of the model were presented using a balance sheet approach and as cost per hernia recurrence avoided and cost per extra day at usual activities. RESULTS Open flat mesh was the most cost-effective method of preventing recurrences. Laparoscopic repair provided a shorter period of convalescence and less long-term pain compared with open flat mesh but was more costly. The mean incremental cost per additional day back at usual activities compared with open flat mesh was Euro 38 and Euro 80 for totally extraperitoneal and transabdominal preperitoneal repair, respectively. CONCLUSIONS Laparoscopic repair is not cost-effective compared with open flat mesh repair in terms of cost per recurrence avoided. Decisions about the use of laparoscopic repair depend on whether the benefits (reduced pain and earlier return to usual activities) outweigh the extra costs and intraoperative risks. On the evidence presented here, these extra costs are unlikely to be offset by the short-term benefits of laparoscopic repair.

Metal on metal hip resurfacing arthroplasty

This paper explores the cost utility of metalon-metal hip resurfacing arthroplasty (MOM) as an alternative intervention to total hip replacement or ‘watchful waiting’ for patients with advanced hip disease. Early implant failure among younger and more active elderly patients can mean that the use of total hip replacement (THR) is delayed, with patients managed through ‘watchful waiting’, a combination of pain control and other non-surgical interventions. Information on costs is combined with evidence on effectiveness from a systematic review in a Markov model in order to estimate the incremental cost per quality adjusted life year (QALY) of MOM relative to THR and ‘watchful waiting’.

Value of updating a systematic review in surgery using individual patient data

Previous research has highlighted the advantages of individual patient data (IPD) meta‐analyses. However, they are resource intensive and take considerable time to complete. The aim of this study was to determine whether the extra investment is justified by greater accuracy or usefulness by means of a case study in surgery.

Use of low-dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

BackgroundChronic obstructive pulmonary disease (COPD) is associated with high morbidity, mortality, and health-care costs. An incomplete response to the anti-inflammatory effects of inhaled corticosteroids is present in COPD. Preclinical work indicates that ‘low dose’ theophylline improves steroid responsiveness. The Theophylline With Inhaled Corticosteroids (TWICS) trial investigates whether the addition of ‘low dose’ theophylline to inhaled corticosteroids has clinical and cost-effective benefits in COPD.Method/DesignTWICS is a randomised double-blind placebo-controlled trial conducted in primary and secondary care sites in the UK. The inclusion criteria are the following: an established predominant respiratory diagnosis of COPD (post-bronchodilator forced expiratory volume in first second/forced vital capacity [FEV1/FVC] of less than 0.7), age of at least 40 years, smoking history of at least 10 pack-years, current inhaled corticosteroid use, and history of at least two exacerbations requiring treatment with antibiotics or oral corticosteroids in the previous year. A computerised randomisation system will stratify 1424 participants by region and recruitment setting (primary and secondary) and then randomly assign with equal probability to intervention or control arms. Participants will receive either ‘low dose’ theophylline (Uniphyllin MR 200 mg tablets) or placebo for 52 weeks. Dosing is based on pharmacokinetic modelling to achieve a steady-state serum theophylline of 1–5 mg/l. A dose of theophylline MR 200 mg once daily (or placebo once daily) will be taken by participants who do not smoke or participants who smoke but have an ideal body weight (IBW) of not more than 60 kg. A dose of theophylline MR 200 mg twice daily (or placebo twice daily) will be taken by participants who smoke and have an IBW of more than 60 kg. Participants will be reviewed at recruitment and after 6 and 12 months. The primary outcome is the total number of participant-reported COPD exacerbations requiring oral corticosteroids or antibiotics during the 52-week treatment period.DiscussionThe demonstration that ‘low dose’ theophylline increases the efficacy of inhaled corticosteroids in COPD by reducing the incidence of exacerbations is relevant not only to patients and clinicians but also to health-care providers, both in the UK and globally.Trial registrationCurrent Controlled Trials ISRCTN27066620 was registered on Sept. 19, 2013, and the first subject was randomly assigned on Feb. 6, 2014.

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy - a randomised controlled trial

BackgroundLaparoscopic surgery has become the preferred approach for many procedures because of reduced post-operative pain, better recovery, shorter hospital stay and improved cosmesis. Single incision laparoscopic surgery is one of the many recent variants where either standard ports or a specially designed single multi-channel port is introduced through a single skin incision. While the cosmetic advantage of this is obvious, the evidence base for claims of reduced morbidity and better post-operative recovery is weak. This study aims to compare the effectiveness of single port/incision laparoscopic appendicectomy with standard three-port laparoscopic appendicectomy in adult patients at six weeks post-surgery. We also wish to assess the feasibility of a multicentre randomised controlled trial comparing single port/incision laparoscopic surgery with standard three-port laparoscopic surgery for other surgical techniques.Methods and designPatients diagnosed with suspected appendicitis and requiring surgical treatment will be randomised to receive either standard three-port or single incision laparoscopic surgery. Data will be collected from clinical notes, operation notes and patient reported questionnaires. The following outcomes will be considered:1. Effectiveness of the surgical procedure in terms of:•patient reported outcomes•clinical outcomes•resource use2. Feasibility of conducting a randomised controlled trial (RCT) in the emergency surgical setting by quantifying:•patient eligibility•randomisation acceptability•feasibility of blinding participants to the intervention received•completion rates of case report forms and patient reported questionnairesTrial registrationISRCTN66443895 (assigned 10 March 2011, first patient randomised 09 January 2011)