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Item The Knee Arthroplasty Trial (KAT) : design features, baseline characteristics and two-year functional outcomes after alternative approaches to knee replacement(Wiley, 2009-01-01) Campbell, Marion Kay; Fiddian, Nick; Fitzpatrick, Ray; Grant, Adrian Maxwell; Gray, Alastair; Morris, Richard; Murray, David; Rowley, David; Johnston, Linda; MacLennan, Graeme Stewart; McCormack, Kirsty; Ramsay, Craig R; Walker, Allan; KAT Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground: 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. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.Item Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease : UK collaborative randomised trial(BMJ, 2009-01-10) Grant, Adrian Maxwell; Wileman, Samantha M; Ramsay, Craig R; Mowat, N Ashley; Krukowski, Zygmunt H; Heading, Robert C; Thursz, Mark R; Campbell, Marion Kay; REFLUX Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesABSTRACT Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Multicentre, pragmatic randomised trial (with parallel preference groups). Setting 21 hospitals in the United Kingdom. Participants 357 randomised participants (178 surgical,179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months. Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care. Main outcome measures The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications. Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group. Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD. Trial registration ISRCTN15517081Item Bowel dysfunction after transposition of intestinal segments into the urinary tract : 8-year prospective cohort study(Elsevier, 2007) Somani, Bhaskar K.; Kumar, Vinod; Wong, Susan; Pickard, Robert; Ramsay, Craig R; Nabi, Ghulam; Grant, Adrian Maxwell; N'Dow, James Michael Olu; ABACUS Research GroupPurpose Bowel function may be disturbed after intestinal segments are transposed into the urinary tract to reconstruct or replace the bladder. In 1997, our group were the first to report major bowel dysfunction in a cohort of such patients: up to 42% of those who were asymptomatic preoperatively describing new bowel symptoms postoperatively including explosive diarrhoea, nocturnal diarrhoea, faecal urgency, faecal incontinence and flatus leakage . We now describe bowel symptoms in this same cohort eight years later (2005). Materials and Methods 116 patients were evaluable. Of the remaining 37 from the original report: 30 had died, five no longer wished to be involved, and two could not be traced. Patients were asked to complete postal questionnaires identical to those used in the first follow-up, assessing the severity of bowel symptoms and quality of life using two validated instruments. Responses were compared with those from the original study. The Nottingham Health Profile quality of life scores were also compared to age and sex matched norms. Results 96 (83%) completed eight-year follow-up questionnaires: 43 after ileal conduit diversion (Group 1), 17 after clam enterocystoplasty for overactive bladder (Group 2), 18 after reconstructed bladder for neurogenic bladder dysfunction (Group 3), and 18 with bladder replacement for non-neurogenic causes (Group 4). High prevalence rates of bowel symptoms persisted with no statistically significant differences between the two time points. Of those with symptoms in 2005, around 50% had reported similar symptoms in 1997. Clam enterocystoplasty patients (Group 2) still reported the highest prevalence (59%) of troublesome diarrhoea with one in two on regular anti-diarrhoeal medication. They also had high rates of faecal incontinence (47%), faecal urgency (41%) and nocturnal bowel movement (18%); with high proportions reporting a moderate or severe adverse effect on work (36%), social life (50%) and sex life (43%). High rates were also reported by neurogenic bladder dysfunction patients, including 50% with troublesome diarrhoea. This symptom was reported by 19% after ileal conduit and by 17% after bladder replacement for non-neurogenic causes. The impact of bowel symptoms on every-day activities and quality of life persisted, remaining most severe after clam enterocystoplasty, with 24% regretting undergoing the procedure because of subsequent bowel symptoms. Conclusions: After more than eight years, operations involving transposition of intestinal segments continue to be associated with high rates of bowel symptoms, which impact on everyday activities. These are particularly troublesome following enterocystoplasty for overactive bladder and bladder reconstruction for neurogenic bladder dysfunction. These risks should influence patient selection and potential patients should be warned prior to surgery.