Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease

NCT02303925 | Completed DMC

• 1 other identifier: 2013-41
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute complications (external and/or internal thromboses) are unpredictable. Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal surgery. This technique consists in a ligation of the superior rectal artery under Doppler control in order to decrease the blood flow within the hemorrhoids and therefore to reduce them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%). With the major advances in interventional radiology such ligation could be performed by an endovascular coil embolization. Until now no direct study exists on the subject but several case reports show the feasibility of an embolization of the superior rectal arteries for rectorrhagia of various etiologies such as the hemorrhoidal disease. Endovascular access should increase the selectivity of the embolization compared to the Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches of the superior rectal artery and therefore to occlude permanently the branches that feed the hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main complications of the trans-anal access technique. The primary objective of this study is : the assessment of the efficacy of endovascular coil embolization of the superior rectal arteries in the management of the symptoms of the hemorrhoidal disease grade II and III. The secondary objective is : the assessment of postoperative complications.

Conditions

Hemorrhoidal Disease

Outcome Measures

Primary Outcomes (1)

• Decrease of the felt pain

  It will be expected a decrease of the felt pain at least of 2 points measured by visual analog scale for patients treated by coil embolization

  26 MONTHS

Secondary Outcomes (1)

• Reaaparition or obstinacy of the hemorroidal symptoms

  26 months

Study Arms (1)

coils

EXPERIMENTAL

Device: NESTER COILS

Interventions

NESTER COILS DEVICE

coils

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient agreeing to participate in the study and who signed an informed consent
• Patient willing to lend to post-operative monitoring for a year
• Patient assured social

You may not qualify if:

• Diseases and colorectal proctologic / History proctologic
• Acute Complication hemorrhoidal disease course (thrombosis)
• History of proctology surgery for hemorrhoidal disease
• Anal stenosis congenital or acquired
• Chronic anal fissure, anal suppuration associated
• Chronic Inflammatory Bowel Disease
• History of colorectal cancer
• History of rectal resection and / or sigmoid
• Rectal prolapse
• Comorbidities
• Portal hypertension
• Severe atherosclerotic pathology (significant stenosis in aorto-iliac-femoral artery or branches for visceral).
• General Affection responsible for a disorder of hemostasis objective (hemophilia, von Willebrand disease thrombocytopenia) and anticoagulants.
• Psychiatric disorder making it impossible informed of and / or postoperative care
• Neurological disease directly or indirectly involving the rectosphinctérienne motor (multiple sclerosis, spinal cord injury or nerve root, polyneuropathy).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13005, France

Location

Study Officials

• Urielle DESALBRES

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• vincent vidal

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 1, 2014
• Study Start: December 14, 2014
• Primary Completion: April 1, 2017
• Study Completion: June 30, 2018
• Last Updated: July 27, 2018

Record last verified: 2016-08

Locations

FR (1)