[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":31,"locations":37,"responsibleParty":217,"collaborators":219,"id":228,"slug":229,"hasResults":230,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":230,"sex":235,"minAge":236,"maxAge":19,"enrollmentInfo":237,"targetDuration":19,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":250,"whyStopped":19,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Elective Adhesiolysis","EXPERIMENTAL","Elective adhesiolysis is a surgical procedure in which all adhesions in the abdomen are released. Elective adhesiolysis is preferably performed laparoscopy, but the precise surgical approach is adjusted to the expected location and extent of the adhesions based on factors including: presence of a stoma, abdominal wall defects, as well as the surgical history and locations of previous scarring.",[13,14],"Procedure: Elective Adhesionlysis","Device: Adhesion barrier",{"label":16,"type":17,"description":18,"interventionNames":19},"Wait-and-see policy","NO_INTERVENTION","A Wait-and-see policy is the current standard of care after a non-operatively treated epsiode of ASBO. No specific intervention or follow-up is performed in the control group of wait-and-see policy.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"PROCEDURE","Elective Adhesionlysis","See descriptions in study arms",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"DEVICE","Adhesion barrier","At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},"Richard PG ten Broek, MD, PhD","CONTACT","+31243611111","richard.tenbroek@radboudumc.nl",[38,54,67,75,88,101,116,129,142,155,168,178,191,204],{"facility":39,"status":19,"city":40,"state":19,"zip":19,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UZ Antwerpen","Antwerp","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.40026,51.22047,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":52,"phoneExt":19,"email":53},"Michiel de Maat, MD, PhD","+32 3 821 30 00","michiel.demaat@uza.be",{"facility":55,"status":19,"city":56,"state":19,"zip":19,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Hôpital Erasme","Brussels",{"type":44,"coordinates":58},[59,60],4.34878,50.85045,{"lat":60,"lon":59},[63],{"name":64,"role":34,"phone":65,"phoneExt":19,"email":66},"Nalja Bachir, MD, PhD","+32 2 555 31 11","najla.bachir@hubruxelles.be",{"facility":68,"status":19,"city":69,"state":19,"zip":19,"country":41,"countryCode":42,"cosmosGeoPoint":19,"geoPoint":19,"contacts":70},"UZ Brussel","Brussles",[71],{"name":72,"role":34,"phone":73,"phoneExt":19,"email":74},"Jasper Stijns, MD, PhD","+32 2 477 41 11","jasper.stijns@uzbrussel.be",{"facility":76,"status":19,"city":77,"state":19,"zip":19,"country":41,"countryCode":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"UZ Leuven (National Coordinating Center)","Leuven",{"type":44,"coordinates":79},[80,81],4.70093,50.87959,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":86,"phoneExt":19,"email":87},"Albert Wolthuis, Prof, MD, PhD","+32 16 33 22 11","albert.wolthuis@uzleuven.be",{"facility":89,"status":19,"city":90,"state":19,"zip":19,"country":41,"countryCode":42,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Vitaz Sint-Niklaas","Sint-Niklaas",{"type":44,"coordinates":92},[93,94],4.1437,51.16509,{"lat":94,"lon":93},[97],{"name":98,"role":34,"phone":99,"phoneExt":19,"email":100},"Jean-Baptiste Cornille, MD, PhD","+323 760 60 60","cornillejb@gmail.com",{"facility":102,"status":19,"city":103,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"ZGT Almelo","Almelo","Netherlands","NL",{"type":44,"coordinates":107},[108,109],6.6625,52.35667,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":114,"phoneExt":19,"email":115},"Esther van den Ende, MD, PhD","+3188 708 7878","e.vdende@zgt.nl",{"facility":117,"status":19,"city":118,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"OLVG Amsterdam","Amsterdam",{"type":44,"coordinates":120},[121,122],4.88969,52.37403,{"lat":122,"lon":121},[125],{"name":126,"role":34,"phone":127,"phoneExt":19,"email":128},"Steve de Castro, MD, PhD","+3120 599 9111","s.m.m.decastro@olvg.nl",{"facility":130,"status":19,"city":131,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Maasziekenhuis Pantein Boxmeer","Boxmeer",{"type":44,"coordinates":133},[134,135],5.94722,51.64667,{"lat":135,"lon":134},[138],{"name":139,"role":34,"phone":140,"phoneExt":19,"email":141},"Klaas Govaert, MD, PhD","+31485 845 000","k.govaert@pantein.nl",{"facility":143,"status":19,"city":144,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"St. Jansdal Harderwijk","Harderwijk",{"type":44,"coordinates":146},[147,148],5.62083,52.34167,{"lat":148,"lon":147},[151],{"name":152,"role":34,"phone":153,"phoneExt":19,"email":154},"Caroline Andeweg, MD, PhD","+31 341 463 911","cs.andeweg@stjansdal.nl",{"facility":156,"status":19,"city":157,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"MaastrichtUMC+","Maastricht",{"type":44,"coordinates":159},[160,161],5.68889,50.84833,{"lat":161,"lon":160},[164],{"name":165,"role":34,"phone":166,"phoneExt":19,"email":167},"Tim Lubbers, MD, PhD","+3143 387 6543","tim.lubbers@mumc.nl",{"facility":169,"status":19,"city":170,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"RadboudUMC","Nijmegen",{"type":44,"coordinates":172},[173,174],5.85278,51.8425,{"lat":174,"lon":173},[177],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},{"facility":179,"status":19,"city":180,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Laurentius Ziekenhuis Roermond","Roermond",{"type":44,"coordinates":182},[183,184],5.9875,51.19417,{"lat":184,"lon":183},[187],{"name":188,"role":34,"phone":189,"phoneExt":19,"email":190},"Jeroen Heemskerk, MD, PhD","+31475 382 222","jeroen.heemskerk@LZR.nl",{"facility":192,"status":19,"city":193,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"St. Franciscus gasthuis Rotterdam","Rotterdam",{"type":44,"coordinates":195},[196,197],4.47917,51.9225,{"lat":197,"lon":196},[200],{"name":201,"role":34,"phone":202,"phoneExt":19,"email":203},"Eva Deerenberg, MD, PhD","+3110 461 6161","e.deerenberg@franciscus.nl",{"facility":205,"status":19,"city":206,"state":19,"zip":19,"country":104,"countryCode":105,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Vie Curie Venlo","Venlo",{"type":44,"coordinates":208},[209,210],6.16806,51.37,{"lat":210,"lon":209},[213],{"name":214,"role":34,"phone":215,"phoneExt":19,"email":216},"Frits Aarts, MD, PhD","+3177 320 5555","faarts@viecuri.nl",{"type":218,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[220,222,225],{"name":221,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":223,"class":224},"KCE Belgian Healthcare Knowledge Centre","UNKNOWN",{"name":226,"class":227},"Baxter Healthcare Corporation","INDUSTRY","100575835","elective-adhesiolysis-vs-a-wait-and-see-policy-to-prevent-recurrences-after-conservative-treatment-of-adhesive-small-bowel-obstruction-100575835",false,"NCT06777446","Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction","AWARE","Inclusion Criteria:\n\n* Adult patients aged 18 years and older who have recently recovered from aSBO by small bowel obstruction managed by conservative treatment.\n* Patients who have previously been operated (high a prior risk of adhesions) are required to have no signs of other causes of bowel obstruction on imaging studies (CT-scan).\n* Patients with no previous operation in history (low a prior risk of adhesions) are required to have typical signs for aSBO on imaging studies (abrupt change of bowel calibre, closed loop, or signs of torsion on vessels in the mesentery on CT-scan).\n\nExclusion Criteria:\n\n* Patient who are unfit for reoperation for surgical, anesthesiological or medical reasons as determined by multidisciplinary team assessment or pre-operative screening\n* Patients with active malignancy, reducing life expectancy\n* Pregnancy","ALL","18 Years",{"count":238,"type":239},380,"ESTIMATED","INTERVENTIONAL",[242],"NA","Rationale: Adhesive small bowel obstruction (aSBO) is a frequent surgical emergency, associated with 3-8% hospital mortality and a high risk of recurrence (20% at two years of follow-up). ASBO can be treated conservatively or by emergency surgery. In the absence of bowel ischemia or strangulation, conservative treatment is often preferred, to avoid the excess morbidity and mortality from emergency surgery. Recent epidemiological studies, however, demonstrate a considerable higher recurrence risk of aSBO after conservative treatment that is associated with hospital readmissions and lower survival. Elective adhesiolysis following successful conservative treatment might reduce these long-term risks whilst avoiding the high complication rate of emergency surgery.\n\nObjective: The investigators aim to assess the efficacy of elective adhesiolysis following conservative treatment for aSBO as compared to the current state of the art (wait-and-see policy) to prevent long-term recurrence of aSBO. Further the investigators will evaluate quality of life, healthcare and societal costs.\n\nStudy design: Multicenter open-label randomized controlled trial, including 380 patients.\n\nStudy population: Adult patients who recovered from aSBO by conservative treatment. Patients that are inoperable for medical, anaesthesiological or surgical reasons are excluded. Intervention (if applicable): The intervention of investigation is elective adhesiolysis. Adhesiolysis is an abdominal procedure in which all adhesions are cut, and adhesion prevention applied to reduce the risk of adhesion reformation. The intervention is compared to wait-and-see policy (the current standard treatment)\n\nMain study parameters\u002Fendpoints: Primary outcome is recurrence, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. The investigators hypothesize a 50% reduction in recurrence in the intervention arm. Secondary outcomes are morbidity from surgery, health-related quality of life (EQ5D), healthcare costs and societal costs (iMCQ and iPCQ)\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nPatients in the intervention group are exposed to abdominal surgery, which is associated with a moderate risk of minor complications such as wound infection and haemorrhage, and a small risk of severe complications such as iatrogenic bowel injury. According to our hypothesis, a potential benefit is the reduction in the risk of recurrences. Recurrence of aSBO is associated with a risk of readmissions, reinterventions, and also increased long-term mortality.",[245],"Adhesive Small Bowel Obstruction",[247,248,249],"Tissue adhesions","Adhesiolysis","Surgery","NOT_YET_RECRUITING","2025-01-10",{"date":253,"type":254},"2025-01-15","ACTUAL",{"date":256,"type":239},"2025-02",{"date":258,"type":239},"2034-02",{"name":5,"class":6},14]