Upper Rectal Artery Embolization in the Treatment of Hemorrhoidal Disease

NCT03402282 | Completed DMC

• 1 other identifier: 72364117.0.1001.0071
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhoidal disease diagnosis is based on medical history combined with physical exam and complementary exam. Physical exam should include inspection at exertion, digital rectal exam ,and anoscopy. The treatment indicated in patients with hemorrhoidal disease varies according to the disease grade, and it may be clinical or surgical. The classic surgical approach is an open surgical correction , a technique that has high success rates and low recurrence rates; however, it is accompanied by intense pain. Based on the concept that hemorrhoids are formed by pathological changes in submucosal pads vascularization in anal channel transition zone, selective embolization of upper rectal artery branches were performed in 14 patients with long-term severe rectal bleeding secondary to hemorrhoidal disease by Vidal et al. with no pain or ischemic symptoms being seen.

• Main Objective To determine the feasibility of implementing upper rectal artery embolization in the treatment of patients with grade 2 (protrude beyond the anal verge with straining or defecating but reduce spontaneously) and 3 hemorrhoids (protrude spontaneously or with straining and require manual reduction), relating its short- and long-term outcomes with patients undergoing surgical repair through the classic technique
• Hypothesis The expectation is that, with upper rectal artery embolization, patients experience a decrease or remission of symptoms, such as bleeding, pain and symptoms related to hemorrhoidal pads edema. Another expectation is that the decrease in the number of days to return to daily activities

Conditions

Hemorrhoidal Disease

Keywords

hemorrhoidal disease; embolization

Outcome Measures

Primary Outcomes (1)

• short and long upper rectal artery versus surgical repair the classic technique

  To determine the feasibility of implementing upper rectal artery embolization in the treatment of patients with grade 2 (protrude beyond the anal verge with straining or defecating but reduce spontaneously) and 3 hemorrhoids (protrude spontaneously or with straining and require manual reduction), relating its short- and long-term outcomes with patients undergoing surgical repair through the classic technique (Milligan and Morgan technique).

  1.5 years

Secondary Outcomes (5)

• impact of upper rectal artery embolization on the treatment of hemorrhoidal disease

  1.5 years

• clinical success of upper rectal artery embolization on the treatment of hemorrhoidal disease.

  1.5 years

• improves symptoms

  1.5 years

• clinical recovery

  1.5 years

• Pharmacoeconomic

  1.5 years

Study Arms (2)

embolization

EXPERIMENTAL

upper rectal artery embolization

Procedure: embolization

surgical treatment

ACTIVE COMPARATOR

surgical repair through the classic technique (Milligan and Morgan technique)

Procedure: surgical repair

Interventions

embolization PROCEDURE

upper rectal artery embolization with coils

Also known as: upper rectal artery embolization

embolization

surgical repair PROCEDURE

surgical repair through the classic technique (Milligan and Morgan technique)

surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged above 18 years old, with internal and/or external hemorrhoids experiencing clinical symptoms (anemia, persistent / recurrent bleeding hemorrhoidal source\> 3 months, episodes of recurrent hemorrhoidal thrombosis (\> 2 episodes) or associated the symptoms of hemorrhoidal disease) with surgical indication and contraindication of band ligation and / or photocoagulation infrared accepting the items pointed in the informed consent form.

You may not qualify if:

• Patients with contraindications for angiogram performance (allergy to intravenous contrast), patients with aortic atherosclerosis (femoral pulse and difference Doppler angiography or with stenosis 20%) patients in the daily use of NSAIDs or weak opioids or who refuse to take part in this project will be excluded from this study.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652900, Brazil

Location

Related Publications (1)

• Falsarella PM, Katz M, Affonso BB, Galastri FL, Arcuri MF, Motta-Leal-Filho JMD, Araujo SEA, Garcia RG, Nasser F. Angiographic description of the superior rectal artery and its anatomical variations in patients undergoing embolization of the superior rectal arteries in hemorrhoidal disease treatment. Einstein (Sao Paulo). 2024 Sep 30;22:eAO0688. doi: 10.31744/einstein_journal/2024AO0688. eCollection 2024.

  PMID: 39356943 DERIVED

MeSH Terms

Interventions

Embolization, Therapeutic; Wound Healing

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 18, 2018
• Study Start: March 6, 2018
• Primary Completion: February 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-08

Locations

BR (1)