Nctid:
NCT06617026
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005401", "term"=>"Fissure in Ano"}], "ancestors"=>[{"id"=>"D000001004", "term"=>"Anus Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M8531", "name"=>"Fissure in Ano", "asFound"=>"Anal Fissure", "relevance"=>"HIGH"}, {"id"=>"M4320", "name"=>"Anus Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "asFound"=>"Chronic", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000013392", "term"=>"Sucralfate"}], "ancestors"=>[{"id"=>"D000000897", "term"=>"Anti-Ulcer Agents"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}], "browseLeaves"=>[{"id"=>"M16179", "name"=>"Sucralfate", "asFound"=>"In vitro diagnostic", "relevance"=>"HIGH"}, {"id"=>"M4188", "name"=>"Antacids", "relevance"=>"LOW"}, {"id"=>"M4219", "name"=>"Anti-Ulcer Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>99}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-08-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"REALISE score", "timeFrame"=>"in each 3 follow up visits (visit 1,2, and 3 after 15, 30 , and 40 days respectively)", "description"=>"REALISE (scoRing systEm for AnaL fIsSurE), will be used to assess pain (score range 0-10), quality of life, duration of pain, intake of analgesics and bleeding. The latter four items were rated on a scale of 1-5"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Chronic anal fissure"], "conditions"=>["Anal Fissure Chronic"]}, "descriptionModule"=>{"briefSummary"=>"Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.", "detailedDescription"=>"Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.\n\nStudy Objective:\n\nPrimary Objectives:\n\n1. To evaluate the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.\n\nStudy Design:\n\nA prospective randomized controlled trial\n\nStudy sampling:\n\nA convenience sampling method will be used; all patients seeking medical advice for CAF at Suez Canal University hospitals, the Faculty of Medicine during the study period and fulfill the inclusion criteria will be recruited. One of the researchers who will make random allocation cards using an Excel formula algorithm will perform simple randomisation.\n\nMethodology:\n\nThis study will include at least 99 patients with CAFs of both genders who will visit the general surgery clinic in the faculty of medicine at Suez Canal University hospital and fulfil the inclusion and exclusion starting from September 2024. Patients of both genders with CAF for the first time, above 18 years old and ASA I/II will be included in the study. While patients with sepsis, previous pelvic radiation, recurrent CAF, with malignancy, on immunosuppressive drugs, with pregnancy or lactation will be excluded. Patients will be randomly allocated into 3 groups at a ratio of 1:1:1 starting with the Sucralfate group. Formal written consent will be obtained from the study participants prior to being involved in the study. All included patients will be followed up to 40 days."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* above 18 years old.\n* CAFs for the first time\n* ASA I, II\n\nExclusion Criteria:\n\n* Sepsis\n* Previous pelvic radiation.\n* recurrent chronic anal fissure\n* Pregnancy or lactation.\n* Immunosuppressive state\n* Malignancy\n* Refusal to participate"}, "identificationModule"=>{"nctId"=>"NCT06617026", "briefTitle"=>"Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure", "organization"=>{"class"=>"OTHER", "fullName"=>"Suez Canal University"}, "officialTitle"=>"Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure (A Randomized Controlled Trial)", "orgStudyIdInfo"=>{"id"=>"#5787"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Sucralfate Group", "description"=>"patients assigned to this group will start to use a topical rectal ointment containing Sucralfate. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.", "interventionNames"=>["Drug: Sucralfate"]}, {"type"=>"EXPERIMENTAL", "label"=>"HyperOil Group", "description"=>"patients assigned to this group will start to use topical oil containing the combination of azadirachtin and hyperforin. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.", "interventionNames"=>["Drug: Azadirachtin"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Surgery", "description"=>"patients assigned to this group will be operated for fissurectomy and lateral sphincterectomy. the follow-up visits are arranged at 15, 30 and 40 days.", "interventionNames"=>["Procedure: fissurectomy and lateral sphincterectomy"]}], "interventions"=>[{"name"=>"Sucralfate", "type"=>"DRUG", "description"=>"a topical rectal ointment. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days", "armGroupLabels"=>["Sucralfate Group"]}, {"name"=>"Azadirachtin", "type"=>"DRUG", "otherNames"=>["azadirachtin and Hyperforin"], "description"=>"a topical oil. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days", "armGroupLabels"=>["HyperOil Group"]}, {"name"=>"fissurectomy and lateral sphincterectomy", "type"=>"PROCEDURE", "description"=>"fissurectomy and lateral sphincterectomy", "armGroupLabels"=>["Surgery"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Ismailia", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Waleed M Ghareeb, MD, PhD", "role"=>"CONTACT", "email"=>"waleed.m.ghareeb@med.suez.edu.eg", "phone"=>"00201094562169"}], "facility"=>"Suez Canal University", "geoPoint"=>{"lat"=>30.60427, "lon"=>32.27225}}], "centralContacts"=>[{"name"=>"Waleed M Ghareeb", "role"=>"CONTACT", "email"=>"waleed.m.ghareeb@med.suez.edu.eg", "phone"=>"01094562169"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Suez Canal University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Senior consultant and lecturer of General surgery", "investigatorFullName"=>"Waleed Ghareeb", "investigatorAffiliation"=>"Suez Canal University"}}}}
