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NCT07844629
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Conditions: Hemorrhoids Internal, Hemorrhoids Second Degree, Hemorrhoids Third Degree
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 102
Sponsor: University of Colorado, Denver
Location: University of Colorado Health Aurora Colorado
Summary
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
Eligibility Criteria
Inclusion Criteria:
* Male or female, aged \>18 years
* Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
* French bleeding score \> 5
* Rectal bleeding greater than 3 months
* Colonoscopy within three years, negative for colorectal malignancy
* INR \< 1.5
* Platelet count \> 150,000/dL
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
* Current use of anticoagulants and/or DAPT
* Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
* Prior surgical or endovascular treatment of hemorrhoids
* Prior endoscopic hemorrhoid artery ligation
* Pregnancy or lactation
* Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
* Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
* Inflammatory bowel disease
* Inflammatory vasculitis or connective tissue disease
* Current participation in another clinical trial which may interfere with participation in this study
* Treatment with bevacizumab within 2 months
* Contraindication to surgical management of internal hemorrhoids
* Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
* Prior pelvic radiation therapy
* Prior diagnosis of portal hypertension
* Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician
Source: ClinicalTrials.gov (NCT07844629). StuddyBuddy aggregates publicly available trial information.