[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Treviso Regional Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100594981","oral-aminaphtone-and-combined-lidocaine-100594981",false,"NCT07026513","ORal Aminaphtone and Combined LidocainE","Observational Study on the Effectiveness of a First-line Therapy With Aminaphtone and Lidocaine Cream in Patients With Hemorrhoidal Disease: a Prospective Monocentric Cohort Study","ORACLE","Inclusion Criteria:\n\n* Adults aged 18 to 85 years\n* Diagnosis of symptomatic internal hemorrhoidal disease (Grade I-IV, Goligher classification)\n* First outpatient consultation for current symptoms\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Active proctologic conditions (e.g., anal fissures, fistulas, condylomas, neoplasms)\n* Inflammatory bowel disease (IBD)\n* Known HIV infection\n* Previous surgical treatment for hemorrhoidal disease (except outpatient procedures performed \\>6 months prior)\n* Current use of psychotropic, antibiotic, antifungal, immunomodulatory, or corticosteroid drugs\n* Known hypersensitivity to Capillarema® or Octosedan® components","ALL","18 Years","85 Years",{"count":21,"type":22},50,"ESTIMATED","1 Month","OBSERVATIONAL","This observational study, called ORACLE (ORal Aminaphtone and Combined LidocainE), is being conducted at Treviso Regional Hospital (Italy) to evaluate the effectiveness of a first-line treatment for patients with internal hemorrhoidal disease (HD). The study focuses on a combination therapy using an oral drug, aminaphtone (Capillarema®), and a topical cream with lidocaine (Octosedan®), compared to standard conservative care.\n\nHemorrhoidal disease is a common condition that can cause bleeding, discomfort, itching, and swelling in the anal area. Many patients experience symptoms that affect their quality of life, even when using standard treatments like fiber supplements and emollient creams.\n\nThis study involves two groups of patients:\n\n* One group will receive oral aminaphtone (Capillarema®) plus lidocaine cream (Octosedan®).\n* The other group will receive standard advice on diet and hydration, along with optional use of lidocaine cream and emollients.\n\nPatients will be followed for 30 days. The main goal is to measure how much the combination treatment improves hemorrhoidal symptoms compared to the standard treatment. This will be assessed using a score called HDSS (Hemorrhoidal Disease Symptom Score). The study will also evaluate quality of life using a specific questionnaire (SHS-HD) and assess how well patients tolerate the treatment.\n\nAbout 50 adult patients will take part, divided into two consecutive groups of 25 each. The study does not involve random assignment or blinding. All participants will be informed about the study procedures and give written consent.\n\nThe results of this study may help doctors better understand the role of aminaphtone in managing hemorrhoidal disease and could improve future treatment recommendations.",[27],"Hemorrhoid","RECRUITING","2025-06-10",{"date":31,"type":32},"2025-06-18","ACTUAL",{"date":34,"type":32},"2025-05-08",{"date":36,"type":22},"2025-07-31",{"name":38,"class":39},"Treviso Regional Hospital","NETWORK",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":49,"studyType":24,"phases":4,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100565179","hemorrhoidal-disease-in-inflammatory-bowel-disease-a-multicenter-prospective-cohort-study-100565179","NCT06638814","HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study","HEAD-IBD-II","Inclusion Criteria:\n\n* age of 18 years and above;\n* established diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease;\n* planned surgery for hemorrhoidal disease during the study period, including hemorrhoidectomy (open, close or submucosal), transanal hemorrhoidal dearterialization, hemorrhoidal laser procedure, stapled hemorrhoidopexy).\n\nExclusion Criteria:\n\n* previous surgery for hemorrhoidal disease other than office-based treatments (e.g., sclerotherapy injection, rubber band ligation);\n* active perianal disease at the time of surgical intervention.",{"count":21,"type":22},"12 Months","Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe.\n\nPrimary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients.\n\nSecondary aim is to identify factors that may affect clinical and surgical outcomes.",[52,27,53,54,55],"IBD (Inflammatory Bowel Disease)","Safety","Sugery","Surgery Related Complications Rate",[46,57,58,59],"Hemorrhoidal disease","IBD","Surgery","NOT_YET_RECRUITING","2024-10-10",{"date":63,"type":32},"2024-10-15",{"date":65,"type":22},"2025-01-01",{"date":67,"type":22},"2027-01-31",{"name":38,"class":39},""]