Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rectal Artery Embolization
Procedure/SurgeryA minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids.
Operative Hemorrhoidectomy
Procedure/SurgeryA surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Rectal Artery EmbolizationExperimental treatment 1 intervention
Group B: Operative HemorrhoidectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life Following Treatment
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life.
Time frame
Baseline and 1 month after treatmentSecondary outcomes
1
Time to Return to Work
Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy.
Time frame
From treatment through return to work or normal activities, up to 6 months after treatment2
Time to Return to Pre-Intervention Activities
Comparison of time to return to pre-intervention activities following superior rectal artery embolization and open surgical hemorrhoidectomy as measured by selected elements of the adapted VEINES questionnaire. Scores range from 3 to 12, with higher scores indicating less limitation in daily, social, and leisure activities and therefore better functional recovery. Lower scores indicate greater activity limitation and poorer functional recovery.
Time frame
From treatment until return to pre-intervention activities, up to 6 months after treatment3
Achievement of French Bleeding Score <2
Comparison of proportion of patients that achieve French Bleeding Scores \< 2 following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. For the French Bleeding Score, total scores range from 0 to 9, with lower scores indicating less bleeding and better clinical outcomes, and higher scores indicating more severe hemorrhoidal bleeding and worse clinical outcomes.
Time frame
6 months after treatment4
Treatment-Related Adverse Events
Comparison of adverse events following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids.
Time frame
From treatment through 6 months after treatmentOther outcomes
1
Correlation of Rectal Arterial Anatomy With Clinical Outcomes
Evaluate number and size of arteries and correlate with observed outcomes.
Time frame
Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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