[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616170":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.",[13],"Drug: Bergmann enema",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Bergmann enema",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Jie Shi","CONTACT","+862085655905","shij36@mail.sysu.edu.cn",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The Sixth Affiliated Hospital, Sun Yat-sen University","Guangzhou","Guangdong","510655","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":24,"phoneExt":19,"email":43},"Lin Xiao Pang","pangxl48@mail.sysu.edu.cn",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100616170","phase-2-preventive-efficacy-of-bergmann-enema-for-acute-radiation-induced-rectal-injury-in-rectal-cancer-patients-undergoing-short-course-radiotherapy-100616170",false,"NCT07302126","Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy","Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy: a Prospective, Single-arm, Phase II Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years, regardless of gender;\n2. Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;\n3. Patients with pathologically confirmed mid-lower rectal cancer;\n4. Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days);\n5. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;\n6. Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.\n\nExclusion Criteria:\n\n1. Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;\n2. Patients who have received pelvic radiotherapy;\n3. Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;\n4. Pregnant or breastfeeding women;\n5. Patients expected to undergo major surgery during the study period;\n6. Participation in other clinical trials within 4 weeks prior to enrollment;\n7. A history of alcohol abuse, drug use, or substance abuse within the past year;\n8. Severe allergic constitution, or allergy to Bergmann;\n9. Inability to cooperate with the enema;\n10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.","ALL","18 Years","75 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines.\n\nPrimary Objective: Incidence of grade 2 or higher radiation-induced rectal injury.\n\nSecondary Objectives: Severity of radiation-induced rectal injury, completion rate of short-course radiotherapy, safety of Bergmann enema, quality of life, pathological complete response (pCR) rate.\n\nStudy Design: Prospective, single-center, single-arm study.\n\nStudy Population and Expected Enrollment: Patients with rectal cancer undergoing short-course radiotherapy, expecting to enroll 40 patients.\n\nTrial Duration: From December 2025 to December 2026.\n\nIntervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.\n\nStatistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 80%, and it is expected that Bergmann enema preventive treatment can reduce it to 50%. The sample size was estimated using a formula designed to calculate single-group rate, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.",[64],"Acute Radiation Enteritis",[66,67,68,17],"Acute radiation-induced rectal injury","Rectal cancer","Short-course radiotherapy","NOT_YET_RECRUITING","2025-12-11",{"date":72,"type":73},"2025-12-24","ACTUAL",{"date":70,"type":58},{"date":76,"type":58},"2026-12-11",{"name":5,"class":6},1]