[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659505":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":13,"centralContacts":33,"locations":13,"responsibleParty":43,"collaborators":13,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":13,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":13,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":13,"overallStatus":66,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Sustained treatment success at 12 months","A patient will be classified as having sustained treatment success if at 12 months all of the following are satisfied: clinically meaningful improvement from baseline; no clinically significant recurrent bleeding; no persistent clinically significant prolapse requiring regular manual reduction; no need for surgical hemorrhoidectomy; no need for another hemorrhoidal intervention beyond the protocolized maximum of two PFS sessions; and satisfactory patient-reported outcome.","12 months follow up",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Hemorrhoidal disease (HD) affects approximately 4% of the population . Its management is typically guided by the Goligher classification and the impact of symptoms on the patient's quality of life. While grade IV HD is usually treated with surgical excision, lower-grade cases can often be managed with less invasive techniques, including office-based procedures such as sclerotherapy and rubber band ligation (RBL), when conservative treatments fail. Sclerotherapy dates back to the nineteenth century as the first minimally invasive treatment described for HD .\n\nPolidocanol (hydroxy-polyethoxy-dodecane) is a synthetic long-chain fatty alcohol, was first used as a sclerosing agent in Germany in the 1960s. polidicanol can be used in treatment of spider veins, reticular veins, varicose veins and hemorrhoids .\n\nPolidocanol works as detergent that cause endothelial destruction and thrombosis, induce sterile inflammation so result in fibrosis and tissue atrophy with vascular obliteration shrinkage and fixation of hemorrhodal cushion so reduction of bleeding and prolapse.\n\nMore recently, polidocanol has emerged as a sclerosing agent, first gaining widespread use in the treatment of varicose veins, before being successfully applied to HD. Its improved safety profile progressively replaced phenol oil as the preferred sclerosing agent, and the introduction of polidocanol foam further enhanced its efficacy compared to the original liquid formulation .\n\nThe use of polidocanol in foam form has gained attention owing to its practical advantages, including cost-effectiveness, less pain, fewer required office-based sessions, rapid recovery as patient can return to normal activity next day and lower incidence of bleeding complications so suitable for patients with bleeding disorders.\n\nThese advancements have led to a shifting paradigm, with sclerotherapy increasingly being considered a first-line treatment for symptomatic grade II-III HD, potentially reserving RBL for recurrent cases .",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"3% polidocanol foam injection in internal hemorrhoids for sclerotherapy","ACTIVE_COMPARATOR","3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam \u002F symptomatic hemorrhoidal cushion, Maximum 3 cushions \u002F session, Maximum plained study dose 6 ml foam \u002F session , Assessment at 4 weeks",[27],"Procedure: Standardized 3% Polidocanol Foam Sclerotherapy",[29],{"type":30,"name":31,"description":25,"armGroupLabels":32,"otherNames":13},"PROCEDURE","Standardized 3% Polidocanol Foam Sclerotherapy",[23],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":13,"email":38},"Radwa Hussein Mohammed, Assistant lecturer at Assuit U","CONTACT","01008056779","radwahmohammed93@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":13,"email":42},"Mohammed Ahmad Medhat, Lecturer at Assuit university","01000493632","mohammed.medhat@aun.edu.eg",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","Radwa Hussein Mohammed Hasanen","Assistant Lecturer","100659505","phase-4-evaluation-of-polidocanol-foam-sclerotherapy-in-symptomatic-internal-hemorrhoids-a-prospective-study-100659505",false,"NCT07866248","Evaluation of Polidocanol Foam Sclerotherapy in Symptomatic Internal Hemorrhoids: A Prospective Study","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Symptomatic internal hemorrhoidal disease.\n3. Goligher grade II or III hemorrhoids.\n4. Predominant hemorrhoidal bleeding (\\>or equal 2 episodes of rectal bleeding\u002F week in last 4 weeks) and\u002For prolapse.\n5. Persistent symptoms despite 4 to 6 weeks of conservative treatment (high fibers diet 25\u002F30 g\u002Fday, increase water intake, avoid straining, stool softening and topical treatment as anesthetics and corticosteroids containing preparations) .\n6. Suitable for outpatient Polidocanol foam sclerotherapy treatment.\n7. Willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Goligher grade IV hemorrhoids.\n2. Predominantly external hemorrhoidal disease.\n3. Acute thrombosed hemorrhoids.\n4. Active anorectal infection.\n5. Anal fissure or fistula responsible for presenting symptoms.\n6. Known colorectal malignancy.\n7. Active inflammatory bowel disease involving the anorectal region.\n8. Uncorrected bleeding disorder.\n9. Known hypersensitivity to polidocanol.\n10. Previous hemorrhoidal surgery substantially altering anorectal anatomy.\n11. Severe uncontrolled systemic illness preventing the procedure.\n12. Pregnancy where treatment is considered inappropriate according to institutional policy.\n13. Inability to provide informed consent.\n14. Inability to complete follow-up.\n\n    \\-","ALL","18 Years","80 Years",{"count":57,"type":58},130,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","To evaluate the efficacy, durability, safety, and clinical\u002Fendoscopic outcomes of standardized 3% polidocanol foam sclerotherapy in patients with symptomatic grade II-III internal hemorrhoids over a 12-month follow-up period.",[64,65],"Internal Piles Sclerotherapy","Internal Hemorrhoids","NOT_YET_RECRUITING","2026-10-04",{"date":69,"type":70},"2026-10-08","ACTUAL",{"date":72,"type":58},"2026-10-01",{"date":74,"type":58},"2028-09-01",{"name":45,"class":6}]