[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625039":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":41,"overallOfficials":24,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":24,"id":80,"slug":24,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":24,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":24,"studyType":92,"phases":24,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Hemoglobin Levels (Hemoglobin Drop)","The difference between preoperative hemoglobin levels and postoperative (first 24 hours) hemoglobin levels to assess surgical bleeding.","From the time of hospital admission (preoperative) up to 24 hours after surgery.",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Morcellation Efficiency Rate","The weight of the resected prostate tissue divided by the morcellation time.","During the surgical procedure (intraoperative).",{"measure":19,"description":20,"timeFrame":17},"Total Operative Duration","Total time from the start of the enucleation to the completion of morcellation.",{"measure":22,"description":23,"timeFrame":17},"Enucleation Efficiency","The weight of the resected tissue divided by the enucleation time.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","RETROSPECTIVE","This is a retrospective, single-center, analytical cohort study conducted at the Ankara Bilkent City Hospital, Department of Urology. The study focuses on evaluating the perioperative and postoperative outcomes of patients who underwent Holmium Laser Enucleation of the Prostate (HoLEP) for symptomatic Benign Prostatic Hyperplasia (BPH).\n\nData will be collected through the Hospital Information Management System (HBYS) and patient archive records for those operated on between January 2024 and 2026. The study population will be divided into two main cohorts:\n\nDutasteride Group: Patients who have been continuously using dutasteride (0.5 mg\u002Fday) for at least 6 months prior to the surgery.\n\nControl Group: Patients with no history of 5-alpha reductase inhibitor (5-ARI) use.\n\nAll surgical procedures were performed by experienced urologists using a standardized HoLEP technique. The following parameters will be analyzed and compared between the two groups:\n\nPrimary Perioperative Outcomes: Enucleation time (minutes), morcellation time (minutes), total operative time, and morcellation efficiency (grams\u002Fminute).\n\nHematological Parameters: Preoperative and postoperative hemoglobin (Hb) levels (first 24 hours) to determine the mean hemoglobin drop.\n\nTissue Analysis: Resected prostate tissue weight (grams) and its correlation with operative duration.\n\nStatistical analysis will be performed to assess whether chronic dutasteride use provides a surgical advantage or alters the tissue characteristics during laser enucleation. Patients with a history of prostate cancer, previous prostate surgery, or those on dutasteride for less than 6 months will be excluded to maintain the integrity of the long-term usage data.","The study population consists of male patients diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) who underwent Holmium Laser Enucleation of the Prostate (HoLEP) at the Ankara Bilkent City Hospital, Urology Clinic. The study includes patients operated on between January 2024 and March 2026. Data will be retrieved from the hospital's electronic health records (HBYS) and patient archives, focusing on those with documented long-term dutasteride use (6 months or more) and those with no history of 5-alpha reductase inhibitor use as a comparison group.",[31,37],{"label":32,"type":24,"description":33,"interventionNames":34},"Dutasteride Group","Patients who were treated with 0.5 mg\u002Fday dutasteride for at least 6 months prior to the HoLEP surgery.",[35,36],"Drug: Dutasteride","Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)",{"label":38,"type":24,"description":39,"interventionNames":40},"Control Group","Patients who underwent HoLEP surgery but had no history of using 5-alpha reductase inhibitors (5-ARIs) before the procedure.",[36],[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":24},"DRUG","Dutasteride","Patients in the study group received 0.5 mg\u002Fday of dutasteride for at least 6 months before surgery as part of their routine BPH treatment.",[32],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":24},"PROCEDURE","Holmium Laser Enucleation of the Prostate (HoLEP)","Standard HoLEP procedure performed for the surgical treatment of benign prostatic hyperplasia.",[38,32],[53],{"name":54,"role":55,"phone":56,"phoneExt":24,"email":57},"Yusuf Gökkurt, MD, Specialist","CONTACT","+905067910557","yusufgokkurt@gmail.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":24,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Ankara Bilkent City Hospital","RECRUITING","Ankara","Universiteler","06800","Turkey (Türkiye)",{"type":67,"coordinates":68},"Point",[69,70],32.85427,39.91987,{"lat":70,"lon":69},[73],{"name":74,"role":55,"phone":75,"phoneExt":24,"email":57},"Yusuf Gökkurt, MD","+90 506 791 0557",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Yusuf Gökkurt","Urology Specialist","100625039",false,"NCT07417449","Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP","The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)","Inclusion Criteria:\n\n* Male patients aged 40 to 80 years.\n* Diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH) and scheduled for elective Holmium Laser Enucleation of the Prostate (HoLEP).\n* For the study group: Documented continuous use of Dutasteride (0.5 mg\u002Fday) for a minimum of 6 months immediately prior to the surgical date.\n* For the control group: No history of 5-alpha reductase inhibitor (5-ARI) use within the last 12 months.\n* Patients with complete medical records available in the Hospital Information Management System (HBYS).\n\nExclusion Criteria:\n\n* Patients with a history of previous prostate surgery or pelvic radiotherapy.\n* Patients diagnosed with prostate adenocarcinoma in the pathology results or those scheduled for a biopsy due to suspicion of prostate cancer prior to the operation.\n* Cases with incomplete data in the hospital's electronic database, including missing operative notes, preoperative\u002Fpostoperative hemoglobin levels, or resected tissue weight.","MALE","40 Years","80 Years",{"count":90,"type":91},1000,"ESTIMATED","OBSERVATIONAL","This study aims to investigate the effects of long-term dutasteride use (a 5-alpha reductase inhibitor) on surgical outcomes in patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP) for benign prostatic hyperplasia (BPH).\n\nWhile some studies suggest that short-term use of these medications can reduce bleeding during surgery, there is limited data on the impact of chronic, long-term use (at least 6 months) specifically during the HoLEP procedure.\n\nThe researchers will retrospectively analyze patient records to compare two groups: those who used dutasteride for 6 months or longer before surgery, and those who did not use any 5-alpha reductase inhibitors. The primary focus is to determine whether long-term dutasteride treatment leads to a significant difference in surgical bleeding (measured by hemoglobin drop), operation time, and the efficiency of removing prostate tissue (morcellation). The findings will help surgeons better understand how preoperative medication history influences the technical aspects of HoLEP surgery.",[95],"Prostatic Hyperplasia, Benign",[97,44,98,99,100],"HoLEP","5-alpha Reductase Inhibitors","Prostate Surgery","Perioperative Bleeding","2026-03-31",{"date":103,"type":104},"2026-04-06","ACTUAL",{"date":106,"type":91},"2026-04-01",{"date":108,"type":91},"2027-04-01",{"name":5,"class":6},1]