Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease (EMBORRHOID)
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|ClinicalTrials.gov Identifier: NCT02303925|
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : July 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoidal Disease||Device: NESTER COILS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease|
|Actual Study Start Date :||December 14, 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||June 30, 2018|
Device: NESTER COILS
- Decrease of the felt pain [ Time Frame: 26 MONTHS ]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
- Reaaparition or obstinacy of the hemorroidal symptoms [ Time Frame: 26 months ]Reaaparition or obstinacy of the symptoms will be assess by clinical exam at 1,3,6 and 12 months
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): NCT02303925
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13005|
|Study Director:||Urielle DESALBRES||Assistance Publique Hopitaux De Marseille|
|Principal Investigator:||vincent vidal||Assistance Publique Hopitaux De Marseille|