Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids (HemEmbo)
Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado Health
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Investigatore principale:
- Jonathan Lindquist, MD
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Contatto:
- Alejandra Aguilar, MPH, CCRP, CPH
- Numero di telefono: 7208486612
- Email: alejandra.aguilar@cuanschutz.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Rectal Artery Embolization
Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A 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. |
|
Comparatore attivo: Operative Hemorrhoidectomy
Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
A surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of Life Following Treatment
Lasso di tempo: Baseline and 1 month after 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. |
Baseline and 1 month after treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to Return to Work
Lasso di tempo: From treatment through return to work or normal activities, up to 6 months after treatment
|
Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy. |
From treatment through return to work or normal activities, up to 6 months after treatment
|
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Time to Return to Pre-Intervention Activities
Lasso di tempo: From treatment until return to pre-intervention activities, up to 6 months after treatment
|
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. |
From treatment until return to pre-intervention activities, up to 6 months after treatment
|
|
Achievement of French Bleeding Score <2
Lasso di tempo: 6 months after treatment
|
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. |
6 months after treatment
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Treatment-Related Adverse Events
Lasso di tempo: From treatment through 6 months after treatment
|
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. |
From treatment through 6 months after treatment
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation of Rectal Arterial Anatomy With Clinical Outcomes
Lasso di tempo: Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
|
Evaluate number and size of arteries and correlate with observed outcomes. |
Arterial anatomy assessed at the time of procedure; clinical outcomes assessed through 6 months after treatment.
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 25-0192
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