[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642494":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":69,"collaborators":25,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":25,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Hitit University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Spinal Anesthesia","ACTIVE_COMPARATOR","Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.",[13],"Procedure: Spinal anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"General Anesthesia","Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.",[18],"Procedure: General anesthesia",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Spinal anesthesia","Spinal anesthesia will be performed at the L3-4 or L4-5 interspace under aseptic conditions using hyperbaric bupivacaine. Light sedation may be administered when clinically required.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"General anesthesia","General anesthesia will be induced and maintained according to the institutional standard protocol. Airway management, mechanical ventilation, anesthetic maintenance, antiemetic prophylaxis, and multimodal analgesia will be applied according to routine clinical practice.",[15],[31],{"name":32,"affiliation":5,"role":33},"Ozgur Yağan, Professor","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Mustafa Serdar Çağlayan","CONTACT","+905074311951","serdar.09.09@hotmail.com",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Sibel Onen Ozdemir","+905442892194","sibelonen89@gmail.com",[45,61],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":25,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hitit university","RECRUITING","Çorum","19030","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],34.95333,40.54889,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":39},"Ozgur Serdar Yagan, Professor","05074311951",{"facility":62,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":25,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"hitit Üniversity",{"type":52,"coordinates":64},[54,55],{"lat":55,"lon":54},[67],{"name":68,"role":37,"phone":60,"phoneExt":25,"email":39},"Mustafa Serdar Caglayan",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mustafa Serdar CAGLAYAN","Medical Doctor","100642494","spinal-versus-general-anesthesia-in-open-simple-prostatectomy-100642494",false,"NCT07643415","Spinal Versus General Anesthesia in Open Simple Prostatectomy","Effect of Spinal Versus General Anesthesia on Postoperative Bleeding in Patients Undergoing Open Simple Prostatectomy: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients aged 18 years or older.\n* Diagnosis of benign prostatic hyperplasia (BPH).\n* Scheduled to undergo open simple prostatectomy.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.\n* Patients scheduled for radical prostatectomy due to prostate cancer.\n* Emergency surgery.\n* Known coagulation disorders or clinically significant thrombocytopenia.\n* Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued according to institutional protocols.\n* Contraindication to spinal anesthesia.\n* Participation in another interventional clinical trial that may affect study outcomes.\n* Administration of tranexamic acid or any additional hemostatic agent during the perioperative period.","MALE","18 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure.\n\nThis prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention.\n\nThe study aims to determine whether spinal anesthesia is associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.",[90,91,92],"Urologic Neoplasms","Benign Prostatic Hyperplasia","Anesthesia",[94,22,95,96],"Open simple prostatectomy","general anesthesia","postoperative bleeding","2026-06-15",{"date":99,"type":100},"2026-06-16","ACTUAL",{"date":102,"type":100},"2026-04-29",{"date":104,"type":84},"2026-09-15",{"name":5,"class":6},2]