[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456090":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":257,"collaborators":259,"id":288,"slug":289,"hasResults":290,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":290,"sex":296,"minAge":297,"maxAge":10,"enrollmentInfo":298,"targetDuration":10,"studyType":301,"phases":10,"briefSummary":302,"conditions":303,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},{"fullName":5,"class":6},"University Hospital Southampton NHS Foundation Trust","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing abdominoperineal excision",null,"Abdominoperineal excision alone consists of removing only the rectum and anus",[13,14,15],"Procedure: Biological mesh reconstruction","Procedure: Myocutaneous flap reconstruction","Procedure: Primary closure reconstruction",{"label":17,"type":10,"description":18,"interventionNames":19},"Patient undergoing infralevator pelvic exenteration","Anterior pelvic exenteration includes resection of the structures of the anterior pelvis, namely the bladder, urethra and inner reproductive organs.\n\nPosterior pelvic exenteration comprises resection of the structures of the posterior pelvic cavity with reproductive organs and rectum, with or without the anal canal.\n\nLateral compartment excision describes the resection of pelvic sidewall structures, such as the iliac vessels, piriformis and obturator internus muscles, and ischium, along with sacrotuberous and sacrospinous ligaments.\n\nTotal pelvic exenteration entails removal of the bladder, urethra, inner reproductive organs, rectum, and anus with their muscles and ligaments.\n\nAn infralevator pelvic exenteration includes the removal of the anus with their muscles and ligaments.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"PROCEDURE","Biological mesh reconstruction","Patients receiving biological mesh of any kind or position as part of their reconstruction during surgery.",[17,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Myocutaneous flap reconstruction","Patients receiving a myocutaneous flap of any kind as part of their reconstruction during surgery.",[17,9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Primary closure reconstruction","Patients receiving primary closure only using any suture material or technique as part of their reconstruction during surgery.",[17,9],[35],{"name":36,"affiliation":37,"role":38},"Kashuf Khan, MBBS MRCS","University Hospitals Southampton","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Charles West, MBBS BSc","CONTACT","+442381208632","charles.west4@nhs.net",{"name":46,"role":42,"phone":10,"phoneExt":10,"email":47},"Malcolm West, MD FRCS PhD","malcolm.west@uhs.nhs.uk",[49,71,84,95,107,118,129,140,151,162,173,181,192,203,214,225,236,246],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Southampton","Hampshire","SO16 6YD","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-1.40428,50.90395,{"lat":60,"lon":59},[63,67,69],{"name":36,"role":42,"phone":64,"phoneExt":65,"email":66},"+44 238120","8632","k.khan@soton.ac.uk",{"name":68,"role":38,"phone":10,"phoneExt":10,"email":10},"Alex Mirnezami, BM BSc PhD",{"name":70,"role":38,"phone":10,"phoneExt":10,"email":10},"Malcolm West, MD PhD",{"facility":72,"status":50,"city":73,"state":74,"zip":75,"country":54,"countryCode":55,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Salisbury NHS Foundation Trust","Salisbury","Wiltshire","SP2 8BJ",{"type":57,"coordinates":77},[78,79],-1.79569,51.06931,{"lat":79,"lon":78},[82],{"name":83,"role":42,"phone":10,"phoneExt":10,"email":10},"Graham Branagan, FRCS",{"facility":85,"status":50,"city":86,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hampshire Hospitals NHS Foundation Trust","Basingstoke",{"type":57,"coordinates":88},[89,90],-1.08708,51.26249,{"lat":90,"lon":89},[93],{"name":94,"role":42,"phone":10,"phoneExt":10,"email":10},"Francesco DiFabio, FRCS",{"facility":96,"status":97,"city":98,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"University Hospitals Sussex NHS Foundation Trust","NOT_YET_RECRUITING","Brighton",{"type":57,"coordinates":100},[101,102],-0.13947,50.82838,{"lat":102,"lon":101},[105],{"name":106,"role":42,"phone":10,"phoneExt":10,"email":10},"Pauline Whitehouse, FRCS",{"facility":108,"status":97,"city":109,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Royal Devon University Healthcare NHS Foundation Trust","Cornwell",{"type":57,"coordinates":111},[112,113],-1.60746,51.94141,{"lat":113,"lon":112},[116],{"name":117,"role":42,"phone":10,"phoneExt":10,"email":10},"Chris Battersby, FRCS",{"facility":119,"status":50,"city":120,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Dorset County Hospital NHS Foundation Trust","Dorchester",{"type":57,"coordinates":122},[123,124],-2.43333,50.71667,{"lat":124,"lon":123},[127],{"name":128,"role":42,"phone":10,"phoneExt":10,"email":10},"Nathan Curtis, FRCS",{"facility":130,"status":97,"city":131,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"NHS Greater Glasgow and Clyde","Glasgow",{"type":57,"coordinates":133},[134,135],-4.25763,55.86515,{"lat":135,"lon":134},[138],{"name":139,"role":42,"phone":10,"phoneExt":10,"email":10},"Colin Steele, FRCS",{"facility":141,"status":50,"city":142,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Leeds Teaching Hospitals NHS Trust","Leeds",{"type":57,"coordinates":144},[145,146],-1.54785,53.79648,{"lat":146,"lon":145},[149],{"name":150,"role":42,"phone":10,"phoneExt":10,"email":10},"Aaron Quyn, FRCS",{"facility":152,"status":97,"city":153,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"London North West University Healthcare NHS Trust","London",{"type":57,"coordinates":155},[156,157],-0.12574,51.50853,{"lat":157,"lon":156},[160],{"name":161,"role":42,"phone":10,"phoneExt":10,"email":10},"Elaine Burns, FRCS",{"facility":163,"status":97,"city":164,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Manchester University NHS Foundation Trus","Manchester",{"type":57,"coordinates":166},[167,168],-2.23743,53.48095,{"lat":168,"lon":167},[171],{"name":172,"role":42,"phone":10,"phoneExt":10,"email":10},"Deena Harji, FRCS",{"facility":174,"status":97,"city":164,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"The Christie NHS Foundation Trust",{"type":57,"coordinates":176},[167,168],{"lat":168,"lon":167},[179],{"name":180,"role":42,"phone":10,"phoneExt":10,"email":10},"Paul Sutton, FRCS",{"facility":182,"status":50,"city":183,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"The Newcastle upon Tyne Hospitals NHS Foundation Trust","Newcastle",{"type":57,"coordinates":185},[186,187],-5.88979,54.21804,{"lat":187,"lon":186},[190],{"name":191,"role":42,"phone":10,"phoneExt":10,"email":10},"Peter Coyne, FRCS",{"facility":193,"status":50,"city":194,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"University Hospitals Dorset NHS Foundation Trust","Poole",{"type":57,"coordinates":196},[197,198],-1.98458,50.71429,{"lat":198,"lon":197},[201],{"name":202,"role":42,"phone":10,"phoneExt":10,"email":10},"Jake Foster, FRCS",{"facility":204,"status":50,"city":205,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Portsmouth Hospitals University NHS Foundation Trust","Portsmouth",{"type":57,"coordinates":207},[208,209],-1.09125,50.79899,{"lat":209,"lon":208},[212],{"name":213,"role":42,"phone":10,"phoneExt":10,"email":10},"Jim Khan, FRCS",{"facility":215,"status":97,"city":216,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Swansea Bay University Health Board NHS Wales","Swansea",{"type":57,"coordinates":218},[219,220],-3.94323,51.62079,{"lat":220,"lon":219},[223],{"name":224,"role":42,"phone":10,"phoneExt":10,"email":10},"Martyn Evans, FRCS",{"facility":226,"status":50,"city":227,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Mid-Yorkshire Hospitals NHS Trust","Wakefield",{"type":57,"coordinates":229},[230,231],-1.49768,53.68331,{"lat":231,"lon":230},[234],{"name":235,"role":42,"phone":10,"phoneExt":10,"email":10},"Adeshina Fawole, FRCS",{"facility":85,"status":50,"city":237,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Winchester",{"type":57,"coordinates":239},[240,241],-1.3187,51.06513,{"lat":241,"lon":240},[244],{"name":245,"role":42,"phone":10,"phoneExt":10,"email":10},"Tim Moore, FRCS",{"facility":247,"status":50,"city":248,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Somerset NHS Foundation Trust","Yeovil",{"type":57,"coordinates":250},[251,252],-2.63211,50.94159,{"lat":252,"lon":251},[255],{"name":256,"role":42,"phone":10,"phoneExt":10,"email":10},"Nader Francis, FRCS",{"type":258,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[260,262,264,265,267,269,271,272,273,275,277,278,280,282,284,286,287],{"name":72,"class":261},"OTHER_GOV",{"name":263,"class":6},"University of Southampton",{"name":119,"class":261},{"name":266,"class":6},"The Leeds Teaching Hospitals NHS Trust",{"name":268,"class":6},"Mid Yorkshire Teaching NHS Trust",{"name":270,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":193,"class":261},{"name":247,"class":6},{"name":274,"class":6},"Swansea Bay University Health Board",{"name":276,"class":261},"Portsmouth Hospitals NHS Trust",{"name":85,"class":6},{"name":279,"class":6},"Royal Devon and Exeter NHS Foundation Trust",{"name":281,"class":6},"Sussex Partnership NHS Foundation Trust",{"name":283,"class":6},"London North West Healthcare NHS Trust",{"name":285,"class":261},"Manchester University NHS Foundation Trust",{"name":130,"class":6},{"name":174,"class":6},"100456090","reconstruction-in-extended-margin-cancer-surgery-100456090",false,"NCT05219058","Reconstruction in Extended MArgin Cancer Surgery","REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study","REMACS","Inclusion Criteria:\n\n* Male and female patients aged 18 or older\n* Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)\n* Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)\n* Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)\n\nExclusion Criteria:\n\n* Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery\n* Patients that undergo surgery by an intersphincteric abdominoperineal resection approach\n* Patients that are unable to complete the questionnaire over the telephone or online with a researcher\n* Patients unable or unwilling to provide informed consent\n* Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service","ALL","18 Years",{"count":299,"type":300},236,"ESTIMATED","OBSERVATIONAL","Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect.\n\nReconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes.\n\nREMACS has three work packages:\n\n1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures.\n2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity.\n3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries.\n\nThe last two work packages have now been funded by an NIHR Research for Patient Benefit Grant",[304,305,306,307],"Surgery--Complications","Pelvic Cancer","Abdominal Cancer","Quality of Life","2025-01-29",{"date":310,"type":311},"2025-01-31","ACTUAL",{"date":313,"type":311},"2022-05-17",{"date":315,"type":300},"2028-01-01",{"name":5,"class":6},18]