Study of Rectal Artery Embolization to Treat Bleeding Internal Hemorrhoids Evaluating Safety, Effectiveness, and Quality of Life

What this Trial Is About

This research aims to evaluate the effectiveness and safety of rectal artery embolization for treating symptomatic bleeding in patients with grade II or III internal hemorrhoids. The study is a prospective, single-arm observational trial conducted at a single center, involving 20 adult patients referred for this treatment by colorectal surgery. The purpose is to assess outcomes and quality of life over a 12-month period following the procedure. Participants will undergo a planned rectal artery embolization procedure using particles and coils performed in vascular and interventional radiology according to standard clinical protocols. The study includes six visits one before the procedure and five follow-ups at 1, 3, 6, and 12 months after embolization. Before the procedure, a research pelvic CT angiography is performed to assess the rectal arteries. Post-procedure, patients receive clinical evaluations and anoscopies at specified intervals, with some visits conducted virtually. Throughout the study, participants will complete patient-reported outcomes and quality of life questionnaires at baseline and during follow-up visits. Researchers will monitor changes in bleeding severity using the French bleeding score, evaluate procedure safety by recording adverse events, and assess the diagnostic accuracy of pre-embolization CT angiography. Secondary measures include pain scales, quality of life scores, and other hemorrhoid severity assessments. The total duration of participation spans 12 months from baseline to final follow-up.

Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids