Real world efficacy of 12 weeks sofosbuvir, daclastivir with ribavirin among cirrhotic pre and post-transplant genotype 3 (2017)

Type of publication:
Conference abstract

Author(s):
Schmidt-Martin D.; Bufton S.; Haydon G.H.; Mutimer D.; Elsharkawy A.M.; Roberts M.; *Rye K.; Singhal S.; Eldred S.; Perry I.; Corbett C.; Unitt E.; Wood V.; Dillon H.

Citation:
Journal of Hepatology; 2017; vol. 66 (no. 1)

Abstract:
Background and Aims: Current EASL guidelines recommend combined Sofosbuvir and Daclatasvir with Ribavirin (SOF + DCV + RBV) for 24 weeks in compensated/decompensated cirrhosis for genotype 3 patients. We investigated response to 12weeks treatment in a large cohort of pre and post-transplant predominantly compensated cirrhotic genotype 3 patients. Methods: All patients who received a single dose and treated in 8 treatment centres within our hospital network included. SVR12 rates for all patients who started treatment are reported on an intention to treat (ITT) basis and we include a modified intention to treat (mITT) analysis excluding non virological failures. Results: 156 patients ((M:F) 109:47) mean age 51.5 were commenced on treatment. The overall SVR12 rate was 88.5% (138/156) (ITT) and 95.8% (138/144) (mITT). 2 patients stopped treatment without side effects. Five patients did not attend for confirmation of SVR12, three patients died on treatment (2 due to cardiac arrest, 1 due to sepsis) and a further patient died following completion of treatment prior to SVR12 (hepatocellular carcinoma). mITT SVR12 for patients with compensated and decompensated cirrhosis (Child Pugh B/C) were 96.7% (116/120) and 82% (23/28)respectively. 96.4% (80/83) of patients with previous exposure to interferon and ribavirin achieved SVR12. All patients with HIV co infection achieved SVR (n = 8). 89% of liver transplant patients achieved SVR. 18%(5/28) of the decompensated cohort (Child Pugh B/C) had died within 2 years of commencing treatment. Conclusions: SOF + DCV + RBV for 12 weeks achieved real world SVR12 rates comparable with 24 weeks treatment in cirrhotic genotype 3 patients or 12 weeks sofosbuvir/velpastasvir. This is the largest reported cohort of posttransplant genotype 3 patients with advanced fibrosis. Our data suggests 12 weeks treatment for all cirrhotic patients may be considered regardless of previous interferon and ribavirin exposure (Table presented).

Coronary heart disease mortality in treated Familial Hypercholesterolaemia: Update of the UK Simon Broome FH Register (2017)

Type of publication:
Conference abstract

Author(s):
Humphries S.E.; Cooper J.A.; Seed M.; *Capps N.; Durrington P.N.; Jones B.; McDowell I.F.W.; Soran H.; Neil

Citation:
Atherosclerosis Supplements; 2017; vol. 28, Pages 41-46

Abstract:
Background: Guidelines for the management of patients with Familial Hypercholesterolaemia (FH) recommend the use of high intensity statin therapy to reduce subsequent risk of Coronary Heart Disease (CHD). Here we compare changes in CHD mortality in patients with heterozygous (FH) pre 1992 before lipid-lowering therapy with statins was used routinely, and in the periods 1992-2008 and 2008 till the present. Methods: Analysis used 1903 Definite (DFH) and 1650 Possible (PFH) patients (51% women) aged 20-79 years, recruited from 21 lipid clinics in the United Kingdom and followed prospectively between 1980-1991 (6627 personyears) 1992-2008 (43117 person-years) and 2009-2016 (17317 person-years). The excess CHD standardised mortality ratio (SMR) compared to the population in England and Wales was calculated (with 95% Confidence intervals). Results: There were 252 deaths from CHD. Overall, treated DFH patients had a higher CHD SMR than PFH patients (post 1991 35% higher 2.40 (2.00-2.86) vs 1.78 (1.44-2.19) p = 0.03). In treated DFH patients with previous CHD the CHD SMR was significantly elevated at all time periods but in men fell from a 4.83-fold excess (2.32-8.89) pre-1992 to 4.66 (3.46-6.14) in 1992-2008 and 2.51 (1.01-5.17) post 2008, while in women these values were 7.23 (2.65-15.73), 4.42 (2.70-6.82) and 6.34 (2.06-14.81)). In treated DFH men with no previous CHD the CHD SMR fell over the three time periods, and was not significantly elevated post 2008 (0.89 (0.29-2.08), but in women the SMR remained significantly elevated (post 2008 3.65 (1.75-6.72)). Conclusions: The data confirm the major benefit in CHD mortality associated with statin treatment, but suggest that FH patients with pre-existing disease, and women with FH may not be being treated adequately.

Impact of PCSK9 inhibitors Alirocumab and Evolocumab on total & LDL cholesterol in clinical practice (2017)

Type of publication:
Conference abstract

Author(s):
*Capps N.

Citation:
Atherosclerosis Supplements; 2017; vol. 28, e13

Abstract:
Background: The PCSK9 inhibitors Alirocumab (Al) and Evolocumab (Ev) were recently recommended for use in the NHS on the basis of NICE TA393 and 394 respectively. Clinical trials of both drugs show rapid, significant and continued reductions in total (TC) and LDL cholesterol (LDLC), however confirmation of their efficacy in UK clinical practice is required. Methods: The first patients in the hospital lipid clinic treated with Al 75 mg (14) or Ev 140 mg (13), with pre and post initiation (after 2-3 injections) fasting bloods, were evaluated. All results are in mmol/L. Results: 19 patients had Familial Hypercholesterolaemia, 9 classed by NICE as high or very high risk. Of the remaining 8 patients 5 were HR and 3 VHR. Overall mean TC and LDLC fell from 7.83 to 5.04 and 5.8 to 3.0, ie by 36 and 48%. For Alirocumab 75 mg mean TC and LDLC fell from 8.21 to 5.71 and 6.20 to 3.48, ie by 30 and 44%; individual reductions were 10 to 45% for TC and 13 to 62% for LDLC. For Evolocumab 140 mg mean TC and LDLC fell from 7.41 to 4.32 and 5.33 to 2.44, reductions of 42 and 54%; individual reductions were 32 to 55% for TC and 45 to 69% for LDLC. LDLC fell below 2.0 in 6 patients (Al 1, Ev 5), the lowest to 1.4 mmol/L. Conclusions: The data confirm the rapid and significant reductions in TC and LDLC with Al and Ev in previously difficult to treat patients, however many still had LDLC higher than ideal. This cohort did not contain patients treated with 150 mg Al, or by both drugs, so a direct comparison is not reported.

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: Study protocol for a randomised controlled trial (2018)

Type of publication:
Journal article

Author(s):
Al-Shahi Salman R.; Dennis M.S.; Innes K.; Drever J.; Dinsmore L.; Williams C.; Whiteley W.N.; Sandercock P.A.G.;  Sudlow C.L.M.; Murray G.D.; White P.M.; Newby D.E.; Sprigg N.; Werring D.J.; Dennis M.; Sudlow C.; Whiteley W.; Lerpiniere C.; McCormick K.; Perry J.; Parakramawansha R.; Hunter N.; Doubal F.; Paulton R.; O'Brien R.; Burgess S.; Mead G.; Taylor P.; MacLeod M.-J.; Maclennan B.; Clarke R.; Taylor V.; Klaasen K.; Crouch N.; Jagpal B.; Furnace J.; Irvine J.; Gow H.; Joyson A.; Nelson S.; Ross S.; Davies R.; Jose D.; Robinson N.; Codd L.; Dodd A.; Moroney H.; Weir P.; Little V.; Gott V.; Sangster G.; Owings P.; Cherian S.; Downham S.; Epstein D.; Webber A.; Qureshi S.; Nicholas P.; Krishnamurthy V.; Shukla A.; Jones I.; Ahmed A.; Cunningham M.; Zahoor T.; Johnson S.; Denniss C.; Albazzaz M.; Ramadan H.; Maguire S.; Patterson C.; Bellfield R.; Hairsine B.; Quinn O.; Hooley M.; Nair A.; Alam M.I.; Greig J.; Rana P.; Robinson M.; Sajid M.; Ball M.; Gascoyne R.; Ghaly G.; Raghunathan S.; Clarke J.; Wilkes G.; Law Z.; Appleton J.; Matias O.; Jackson B.; Keshvara R.; Whittamore K.; Jordan C.; Sheikh S.; Roffe J.; Gilzeane N.; Krishnan K.; Buck A.; Havard D.; Hedstrom A.; Shelton F.; Godfrey M.; Webster T.; Haider S.; Seagrave S.; Leason S.; Nallasivan A.; Chatterjee K.; Perkins C.; Mohd Nor A.; Persad N.; Eglinton C.; Brown C.; Weinling M.; Shah A.; Baker J.; Hyams B.; Kini M.; Fong R.; Chadha D.; Walstow D.; Proeschel H.; Sharpe S.; Horton S.; Jones S.; Byrne A.; McGhee C.; Smart A.; Copeland C.; Dutta D.; Bakawala R.; O'Connell S.; Hughes C.; Brown P.; Davis F.; Collins K.; Ward D.; Turfrey J.; Rudd T.; Marks K.; Kullane S.; Jonathan B.; Bhalla A.; Yip B.; Bell M.; MacInnes B.; Macliver L.; Esson D.; Yadava R.; Stafford S.; Reddan J.; Sangombe M.; Azhar K.; Jenkins C.; Price F.; Mercer L.; Vasileiadis E.; Mason C.; Aweid B.; Holden M.; Parry A.; Landers G.; Broughton D.; Chapman K.; Sigsworth A.; Tryambake D.; Young A.; Dixon L.; Bergin A.; Barber M.; Brodie F.; Anjum T.; Connor L.; Tucker S.; Thomas S.; Davies C.; Slade P.; Treadwell S.; Wani M.; Beaty T.; Krishnan M.; Dacey L.; Spencer J.; Quinn L.; Chenna S.; Storton S.; Jones T.; Jones H.T.; Hussain M.; Homan J.; Foster E.; Brotherton L.; Durman H.; Hunt N.; Foot J.; Whitcher A.; Pawley C.; Khan M.; Whiting R.; Harvey M.; Brown S.; Foote L.; Richard B.; Triscott C.; Edwards M.; Lawson H.; Wallace R.; Nott C.; Moseley S.; Buckle S.; Sarah P.; Whiteman J.; Fotherby K.; Butler D.; Willberry A.; Ahmad N.; Jennings-Preece K.; Baig F.; Morgan D.; Stevens A.; Metcalf K.; McDonald S.; Ravenhill G.; Anversha A.; Shinh N.; Perfitt R.; Greenwood R.; Saada J.; Waterfield K.; Sutton P.; Jagger J.; Wiltshire A.; Luder R.; Johnson V.V.; Bridger H.; Bhargava M.; Gallagher J.; Adesina T.; van Someren C.; Carpenter M.; Walker M.; Stanners A.; Ball J.; Jackson L.; Datta P.; Bateman G.; Fathima R.; Davey R.; Needle A.; Siddegowda P.; Ponnambath S.; Suttling A.; Harrington-Davies Y.; Butler R.; James M.C.; Valentine M.S.; Dobson T.; Howard P.; Tandy J.; Hyatt L.; Jarrett D.; Saulat A.; Sims D.; Willmot M.; Green C.; Jones R.; Cunningham J.; Maiden S.; Sutton C.; Hurley J.; Littleton E.; Shekhar R.; Crown R.; Ahmed I.; Fuller S.T.; Gilham E.; Andole S.; Gadapa N.; Dunne M.K.; Krommyda M.; Burssens E.; King S.; Goorah N.; Bell A.; Patel F.; Tomlinson B.; Duberley S.; Singh A.; Kelly C.; Walford J.; Harrington F.; Schofield C.; Lucas L.; Ellis S.; Bond K.; Mate A.; Adie K.; James A.; Maund B.; Courtauld G.; Mudd P.; Hemsley A.; Thorpe K.; Gupwell K.; Goff A.; Sword J.; Roughan C.; Strain D.; Cageao J.; Bowring A.; Keenan S.; James M.; Kingwell H.; Miller K.; Harkness K.; Doyle C.; Majis A.; Stocks K.; Maatouk A.; Barron L.; Dakin K.; Lindert R.; Kamara C.; Bayliss P.; Redgrave J.; Kibutu F.; Blank C.; Ali A.; Balitska O.; Birchall K.; Richards E.; Howe J.; Smyth N.; Giallombardo E.; Sykes L.; Wilson J.; Langhorne P.; McAlpine C.; Humphreys L.; Iqbal M.S.; Graham R.; Kerr G.; Wright F.; Kumar P.; Thomas P.; Culmsee C.; Huggett I.; Dunn M.L.; Barker J.; Manoj A.; Fitzsimmons P.; Lopez M.P.; Sharma N.; Cox P.; Fletcher G.; Wilkinson M.; Emsley H.; Raj S.; Doyle D.; Gregory B.; Punekar S.; Sultan S.; McLoughlin A.; Pasco K.; Balazikova M.O.; Nasim A.; Peixoto C.; Kane I.; Pitt- Ford A.; Hervey S.; Thompson P.; Latter M.L.; Barbon E.; Breeds J.; Rajkumar C.; Gainsborough N.; Gaylard J.; Choulerton J.; Shaw L.; Madigan B.; Howcroft D.; Lucas S.; Stone A.; Avis J.; Gbadamoshi L.; Button D.; Stephanie M.; Dow L.; Davis M.; Thompson T.; Hogg V.; Hays C.; Fawcett M.; Atkinson N.; Guy H.; Woodward S.; Parry-Jones A.; Marshall S.; Jarapa R.; Lee S.; Harrison L.; Johnes M.; Oloughlin V.; Wood E.; Perez J.; Naing Z.; Morell J.; Marsden T.; Ingham A.; Burger I.; Shaw K.M.; Hall A.; Punter M.; Weir N.; Evans S.; Walters A.; Gartrell M.I.; Smith M.F.; Cox M.C.; Smith C.N.S.; Egerton S.; Creeden R.; Marigold J.R.; Blades A.; Crawford P.; Battersby- Wood E.; Pressly V.; Allen C.; Howard G.; Muir K.; Kalladka D.; Smith W.; Day N.; Moreton F.; Cheripelli B.K.; Huang X.; Welch A.; El Tawil S.; Ramachandran S.; Crosbie C.; Elliot J.; Cluckie G.; Clarke B.; Dayal N.; Orefo C.; Adedoyin T.; Ghatala R.; Clarke N.; Jones V.; Blight A.; Lovelock C.; Chopra N.; Moynihan B.; Kennedy K.; Williams R.; Kerin M.L.; Jeyaraj M.N.; Choy L.; Watson F.; Trippier S.; O'Reill J.; Haque M.; Symonds S.; Maanoosi M.; Herman J.; Vassallo J.; Krishnamoorthy S.; Cochrane H.; Walter D.; O'Connell J.; Fox C.; Krishnamurthy R.; Osborne E.; Smith A.; Mokoena B.; Gulliver D.; Brew H.; Myint M.; Majmudar N.; Bunea G.; Sattar N.; *Srinivasan M.; *Mukherjee I.; *Motherwell N.; *Donaldson D.; *Campbell R.; *Hurford F.; Thavanesan K.; David O.; Tiwari D.; Hann G.; Longland B.; Bell J.; Rogers M.E.; Bagnall M.C.; Iqbal M.A.; Keltos M.; Jupp B.; Roberts J.; Cox C.; Ovington C.; Bhaskaran B.; Garfield-Smith J.; Buxton J.; Horan K.; Ayres G.; Bearne H.; Tomlin D.; Szabo S.; Kelly D.; Salih I.; Bhakri H.; Fitzell P.; Wilson D.; Wroath B.; Dynan K.; Power M.; Thompson S.; Ghosh S.; Henry M.; Gilmour D.; Barrie E.; Kenton A.; Nyabadza M.S.; Martin M.I.; Hunt B.; Hassan H.; Dallol B.; Muddegowda G.; Hiden M.J.; Maguire H.; Grocott J.; Finney K.; Barry A.; Roffe C.; Lyjko S.; Sanyal R.; Remegoso A.; Ferdinand P.; Butler A.; Abano N.; Causley M.C.; Denic H.; Carpio R.; Stevens S.; Moores A.; Varquez R.; Pai Y.; Bruce D.; Dima S.; Baliga V.; Naeem M.; Rogers G.; Brown E.; Hayman R.; Garside M.; Dhakal M.; Smith G.M.; Clayton S.; Orugun E.; Poultney U.; Glover R.; Crowther H.; Thornthwaite S.; Webb T.; Beranova E.; Walker S.; Cosier T.; Rudenko H.; Cowie L.; Verrion A.; Thomson A.; Gamble E.; Charles B.; Grue R.; Blane S.; Hague A.; Rashed K.; Vickers C.; Wood D.; Board J.; Buckley C.; Allison J.; Board S.; William-Yesson B.; Balian L.; Keeling E.; Kar A.; Halse O.; Nguyen V.; Harvey K.; Gardener L.; Mashate S.; Tilley V.; Wilding P.; Geraghty O.; Hazel B.; Harrison T.; Cuenoud L.; Auld G.; Erumere E.; Redjep O.; Grimwood G.; Howaniec L.; Hove D.; Salek-Haddadi A.; Saastamoinen K.; Argandona L.; Wiggam I.; Wallace A.; Cuddy S.; Tauro S.; Hunter A.; Kerr E.; Fulton A.; Putterill J.; Kakar P.; Jha R.; Gallifent R.; Pusalkar A.; Chan K.; Dangri P.; Crabtree K.; Beadle H.; Cook A.; Black T.; Cronin J.; Fennelly R.; Tribbeck M.; Clarke C.; Miriam S.; Anthony A.; Mead D.; Esisi B.; Bokhari M.; Cassidy T.; McClelland B.; Cooper M.; Wynter I.; Rajapakse A.; Nasar M.; Anwar I.; Ramshaw A.; Annamalai A.; Crawford S.; Nozedar T.; Skinner H.; Kumar B.; McArdle D.; Holmes C.; Dodd E.; Clarke S.; Caine S.; Baker P.; Murphy P.; Osborn M.; Guthrie L.B.; Steele A.; Devitt N.; Mangion D.; Fletcher J.; Hardwick A.; Constantin C.; Markova S.; Lawrence T.; Subramonian S.; Temple M.N.; Owusu-Agyei P.; Butterworth-Cowin N.; Werring D.; Hogan C.; brezitski M.; Elliott E.; Francia N.; Ashton A.; Hostettler I.; Oji N.; Banaras A.; Patel K.; Crook L.; Watchurst C.; Erande R.; Sekaran L.; Mohammed N.; Chauhan M.; Sethuraman S.; Simon R.; Bharaj K.; Tate M.; Justin F.; Phiri D.; Hewitt J.; Gray J.; Mardania R.; Procter M.S.; Elfandi K.; Khan U.; Ragab S.; Knops K.; Jinks E.; Dickson C.; Gleave L.; Leggett J.; Dube J.; Garcia T.; McIlmoyle J.; Anwar S.; Dhar S.; Jones K.; Jeffs C.; Dickinson C.; Howard J.; England T.; Donnelly R.; Maddula M.; Hassan A.; Veraque E.; Kambafwile M.; Makawa L.; Randall M.; Papavasileiou V.; Waugh D.; Ispoglou S.; Hayes A.; Ankolekar S.; Evans R.; Ni H.; Graham C.; Jose J.; Milligan J.; Rahman B.; Findlay P.; Macaden A.; Shread I.; Keegan B.; Blair C.; Kelly J.; Doherty M.; Dewar R.; White J.; Thomas K.; Cohen D.; David A.; Owoyele E.; Njoku K.; Poku P.; Sukdeo V.; Chandrakumar A.; Chamberlain A.; Abbdulsaheb M.; Guo F.; Oshodi M.A.; Licenik R.; Devine J.; Davies S.; Nisar N.; Niranchanan R.; Roganova T.; Mpelembue M.; Burgess L.; Bathula R.; Ngwako M.; Eveson D.; Mistri A.; Stephens C.; Musarrat K.; Lam M.Y.; Sattar S.; Khan S.; Moqsith M.; Manning L.; Patel C.; Schulz U.; Kennedy J.; Ford G.; Harston G.; Teal R.; Mathieson P.; Lenti G.; Reckless I.; Cullen C.; Stevenson S.; Harrison M.; Ewing J.; Shackcloth D.; Durairaj R.; Zoe M.; Ingram T.; Thant H.; Peters J.; Sutton V.; Ivatts S.; Amey I.; Clayton-Evans L.; Baird Y.; Sally M.; Newton S.; Guyler P.; Ng K.X.; Prabakaran R.O.; Ngo D.; Rashmi S.; Coward L.; Menon N.; Kelavkar S.; Kunhunny S.; Sinha D.; Siddiqui A.; Loganathan T.; Tysoe S.; Shah S.; Kalathil L.; Gautam N.; Meir J.; Bailey D.; Salehin M.; Miller R.; Kelly A.; Rayessa R.; Rodgers A.; Wilson L.; Naylor C.; Wilson S.; Clarkson E.; McCarron M.; McVerry F.; McKee S.J.; Cvoro V.; Ullah K.; Chapman N.; Couser M.; Mcauley S.; Pound S.; Nicolson A.; Imam J.; Wood L.; O'Brien E.; Hannon N.; Finlay S.; Hayhoe H.; Handley D.; Kelly S.; Mcgee J.; Mitchell J.; Amis E.; Sesay J.; Crisp S.; Francis J.

Citation:
Trials; Mar 2018; vol. 19 (no. 1)

Abstract:
Background: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs. Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigatorled, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study). Discussion: Final results of RESTART will be analysed and disseminated in 2019.

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Early and late pregnancy outcomes in women treated with cold-coagulation versus LLETZ cervical treatment for cervical intraepithelial neoplasia; a retrospective cohort study (2018)

Type of publication:
Journal article

Author(s):
*Papoutsis, Dimitrios; *Underwood, Martyn ; *Parry-Smith, William; *Panikkar, Jane

Citation:
Archives of Gynecology and Obstetrics; Apr 2018; Vol.297(4):1015-1025

Abstract:
PURPOSE To compare the pregnancy outcomes between women who were treated with cold-coagulation versus large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia. METHODS This was a retrospective cohort study of women who had a single cervical treatment between 2010 and 2011. We identified those women who had a singleton pregnancy subsequent to their cervical treatment until September 2017. Women with previous cervical treatment, previous miscarriage or preterm delivery were excluded. RESULTSWe identified 86 women with a pregnancy after LLETZ treatment and 75 women after cold coagulation. Those who had LLETZ when compared to cold coagulation miscarried more often in the first trimester (33.7 vs 17.3%; p = 0.01) than in the second trimester. In women with LLETZ this effect of increased early miscarriage was shown to be prolonged and to persist up to 17 months after excision. Women with LLETZ when compared to cold coagulation had higher spontaneous preterm birth rates (8.9 vs 6.7%) even though the difference was non significant, with the earliest spontaneous preterm birth occurring at 32 weeks and 34 weeks, respectively. CONCLUSION We found that women who received LLETZ treatment when compared to cold coagulation had higher spontaneous preterm birth rates in their subsequent pregnancy and miscarried more frequently in the first trimester, and demonstrated an increased early miscarriage risk that persisted for more than a year after excisional treatment.

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Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: Study protocol for a randomized controlled trial (2018)

Type of publication:
Randomised controlled trial

Author(s):
Ugo Grossi, Natasha Stevens, Eleanor McAlees, *Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S. Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H. Knowles, and On behalf of the NIHR CapaCiTY working group

Citation:
Trials; Feb 2018; vol. 19 (no. 1)

Abstract:
Background: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence. Methods: An individual level, stepped-wedge randomised trial has been designed to allow observer-blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate. They will be randomised to three arms with different delays before surgery (0, 12 and 24 weeks). Efficacy outcome data will be collected at equally stepped time points (12, 24, 36 and 48 weeks). The primary objective is to determine clinical efficacy of LVMR compared to controls with reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) at 24 weeks serving as the primary outcome. Secondary objectives are to determine: (1) the clinical effectiveness of LVMR to 48 weeks to a maximum of 72 weeks; (2) pre-operative determinants of outcome; (3) relevant health economics for LVMR; (4) qualitative evaluation of patient and health professional experience of LVMR and (5) 30-day morbidity and mortality rates. Discussion: An individual-level, stepped-wedge, randomised trial serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the waiting-listed participants an opportunity to obtain the intervention at a later date. In keeping with the basic ethical tenets of this design, the average waiting time for LVMR (12 weeks) will be shorter than that for routine services (24 weeks).

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Effectiveness of intragastric balloon as a bridge to definitive bariatric surgery in the super-obese endoscopic and percutaneous interventional procedures (2017)

Type of publication:
Conference abstract

Author(s):
*Ball W.; *Raza S.S.; *Loy J.; *Riera M.; *Pattar J.; *Adjepong S.; *Rink J.; *Lyons H.; *Price B.

Citation:
Obesity Surgery; Jul 2017; vol. 27 (Supplement 1); p. 335

Abstract:
Introduction: Super Obese patients with body mass index (BMI) > 60KG/M2 pose particular difficulties for primary laparoscopic bariatric surgery. Laparoscopic port access, stapling and suturing become increasingly difficult with higher BMI. Our unit's practice of placing an intragastric balloon for 6 months prior to definitive surgery in patients with BMI > 60KG/M2 aims to make definitive surgery less difficult by reducing weight. Objectives: To quantify weight loss after balloon placement and determine if these patients subsequently underwent definitive bariatric surgery. Methods: Retrospective review of 46 consecutive patients with intragastric balloon placement using SPSS statistical analysis on the results. Results: Median weight loss 14kg (0-42) P<0.0001, median % excess weight loss (%EWL) 15% (-3.3-64.66) P<0.001 and median BMI reduction 5KG/M2 (-1.3-13.9) P<0.001. 29/46 (63%) patients underwent definitive bariatric surgery. 10/46 (22%) patients had minor complications (nausea, vomiting and pain) requiring re-admission, of these 7/10 (70%) had early balloon removal and 6/10 (60%) did not have definitive bariatric surgery. 6/46 patients had second balloon placement median weight loss-6kg (-22-33), median %EWL-4.85% (-21.6-34.96), median BMI reduction-1.3KG/M2 (-8.5-2.5). Conclusion: Results from intragastric balloon placement are encouraging and comparable with a recent metaanalysis. Re-admissions and low %EWL with the first balloon are predictors for early balloon removal and failure to proceed to definitive surgery. Intragastric balloons as a bridge to definitive bariatric surgery are effective and safe. Sequential intragastric balloons are not recommended.

Prostatic abscess: A rare complication of staghorn calculi (2018)

Type of publication:
Journal article

Author(s):
*Quraishi M.K.; *Phan Y.C.; *Asaad W.; *Lynn N.

Citation:
BMJ Case Reports; 2018; vol. 2018

Abstract:
A staghorn calculus is a calculus accommodating the majority of a renal calyx extending into the renal pelvis. A conservative approach to its treatment may lead to high morbidity and mortality rates. Such morbidity usually manifests with renal failure, obstructed upper urinary tractand/or life-Threatening sepsis. Prostatic abscesses have never been associated with staghorn calculi in the literature. We report a case of a 70-year-old man who presented with sepsis, which was found to originate from a complex prostatic abscess. The patient had no history of urinary tract infections or risk factors. The authors believe that the incidentally identified staghorn calculi promoted the growth of Proteus mirabilis which led to the development of the prostatic abscess. The patient underwent a transurethral resection and drainage of the abscess following a failed course of antibiotic therapy. This case also highlights the paucity of guidelines available in treating prostatic abscesses.

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