Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697562
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2022-12-21
Brief Title:
Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
A Randomized Comparative Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma Feasibility efficacy and safety were studied in several trials A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD
Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery Furthermore DG-HAL and RBL are equally effective procedures The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplateletanticoagulation therapy in terms of symptom control and bleeding non-inferiority study
Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery Furthermore DG-HAL and RBL are equally effective procedures The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplateletanticoagulation therapy in terms of symptom control and bleeding non-inferiority study
Detailed Description:
Hemorrhoidal disease HD is the most common anorectal pathology Therapeutic management of HD ranges from conservative treatment and instrumental treatment to surgical approach Beside these certain minimally invasive techniques such as radiofrequency ablation laser coagulation and Superior Rectal Artery Embolization SRAE are gaining interest SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma Feasibility efficacy and safety were studied in several trials A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery Furthermore DG-HAL and RBL are equally effective procedures The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplateletanticoagulation therapy in terms of symptom control and bleeding non-inferiority study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None