Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids (HemEmbo)

22 september 2026 bijgewerkt door: University of Colorado, Denver

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

102

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • University of Colorado Health
        • Hoofdonderzoeker:
          • Jonathan Lindquist, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Rectal Artery Embolization

Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
Procedure: Rectal Artery Embolization

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.
Actieve vergelijker: Operative Hemorrhoidectomy

Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
Procedure: Operative Hemorrhoidectomy

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of Life Following Treatment
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Return to Work
Tijdsspanne: 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
Time to Return to Pre-Intervention Activities
Tijdsspanne: 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
Tijdsspanne: 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
Treatment-Related Adverse Events
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation of Rectal Arterial Anatomy With Clinical Outcomes
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Colorado, Denver

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

19 oktober 2026

Primaire voltooiing (Geschat)

19 oktober 2028

Studie voltooiing (Geschat)

19 oktober 2028

Studieregistratiedata

Eerst ingediend

22 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2026

Eerst geplaatst (Werkelijk)

28 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 25-0192

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren