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Upper Rectal Artery Embolization in the Treatment of Hemorrhoidal Disease

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ClinicalTrials.gov Identifier: NCT03402282
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

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

Condition or disease Intervention/treatment Phase
Hemorrhoidal Disease Procedure: embolization Procedure: surgical repair Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Upper Rectal Artery Embolization in the Treatment of Hemorrhoidal Disease
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: embolization
upper rectal artery embolization
Procedure: embolization
upper rectal artery embolization with coils
Other Name: upper rectal artery embolization
Active Comparator: surgical treatment
surgical repair through the classic technique (Milligan and Morgan technique)
Procedure: surgical repair
surgical repair through the classic technique (Milligan and Morgan technique)



Primary Outcome Measures :
  1. short and long upper rectal artery versus surgical repair the classic technique [ Time Frame: 1.5 years ]
    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).


Secondary Outcome Measures :
  1. impact of upper rectal artery embolization on the treatment of hemorrhoidal disease [ Time Frame: 1.5 years ]
    To assess the impact of upper rectal artery embolization on the treatment of chronic bleeding secondary to hemorrhoidal disease, on clinical success rate.

  2. clinical success of upper rectal artery embolization on the treatment of hemorrhoidal disease. [ Time Frame: 1.5 years ]
    To assess the impact of upper rectal artery embolization on the treatment of chronic bleeding secondary to hemorrhoidal disease, on need of retreatment.

  3. improves symptoms [ Time Frame: 1.5 years ]
    To assess the impact of upper rectal artery embolization on the treatment of chronic bleeding secondary to hemorrhoidal disease, on symptom relapse

  4. clinical recovery [ Time Frame: 1.5 years ]
    To assess the impact of embolization on the time required for clinical recovery and return to daily activities

  5. Pharmacoeconomic [ Time Frame: 1.5 years ]
    Pharmacoeconomic assessment of the comparison between upper rectal artery embolization methods for hemorrhoidal disease treatment and conventional surgical treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402282


Contacts
Contact: priscila falsarella +551121510434 primina@gmail.com
Contact: hemodinamica hospital israelita albert eisntein +551121510434

Locations
Brazil
Hospital Israelita Albert Einstein Recruiting
Sao Paulo, Brazil, 05652900
Contact: priscila falsarella, md    +551121510434    primina@gmail.com   
Sponsors and Collaborators
Hospital Israelita Albert Einstein

Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03402282     History of Changes
Other Study ID Numbers: 72364117.0.1001.0071
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Israelita Albert Einstein:
hemorrhoidal disease
embolization