[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07161765":3,"trial-entities:NCT07161765":73,"trial-summary:NCT07161765":77},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":53,"locations":56,"central_contacts":66,"overall_officials":67,"references":71,"see_also_links":72},"NCT07161765","HUM00275895","Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids","ENROLLING_BY_INVITATION","2027-05-01","2026-06","2026-06-04","2025-12-05","University of Michigan","OTHER",true,"This study aims to understand the mechanisms of straining on anorectal testing, to better help people receive more effective treatment advice. The study also aims to understand how anorectal function testing helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.","Patients take an online survey to assess symptom burden prior to undergoing anorectal function testing to evaluate pelvic floor symptoms that can cause hemorrhoidal disease. There are no study visits outside of routine clinical care.",[18,19],"Bleeding Hemorrhoids","Rectal Evacuation Disorders",[21],"Anorectal testing","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Anorectal manometry","Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan for anorectal manometry.",[32],[36],{"measure":37,"description":38,"timeFrame":39},"Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores","The PAC-SYM survey has 12 questions in which participants select from Absent (0)-Very severe (4) There is a range of scores from 0-48 with a higher score indicating more severe symptoms.\n\nThe HDSS survey has 5 questions in which participants select from Never (0)- Every day (always) (4).\n\nThere is a range of scores from 0-20 with a higher score indicating more severe symptoms.\n\nICC will be assessed between overall PAC-SYM and Hemorrhoid Disease Symptom Score (HDSS) sum scores, with a value of \\>0.70 considered acceptable. A sample size of 100 patients is typical to achieve a minimum acceptable ICC of 0.70 with a confidence interval of 0.10.","Day 1 (standard of care clinic visit)",[],"ALL","18 Years",null,false,{"inclusion":46,"exclusion":49,"raw_text":52},[47,48],"Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids).","Participants provider placed an order for anorectal manometry to the University of Michigan",[50,51],"Anal fissure","Pregnancy","Inclusion Criteria:\n\n* Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids).\n* Participants provider placed an order for anorectal manometry to the University of Michigan\n\nExclusion Criteria:\n\n* Anal fissure\n* Pregnancy",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"University of MIchigan","Ann Arbor","Michigan","48109","United States",{"lat":64,"lon":65},42.27756,-83.74088,[],[68],{"name":69,"affiliation":12,"role":70},"Eric Shah, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":74,"biomarkers":76},[75,19],"Hemorrhoidal Hemorrhage",[],{"nct_id":4,"found":44,"summary":43,"prompt_version":43}]