Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896268
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-05-17
Brief Title:
Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
Sponsor:
Elsan
Organization:
Elsan
Study Overview
Official Title:
Prospective Multicentric Randomized Open-label Study Comparing the Efficacy in Terms of Quality of Life and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
Status:
RECRUITING
Status Verified Date:
2024-06
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:
RADO
Brief Summary:
Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus internal haemorrhoids or under the skin of the anus external haemorrhoids Haemorrhoidal disease HD occurs when haemorrhoids become troublesome and cause symptoms such as pain bleeding prolapse or oozing In case of failure of medical treatment instrumental procedures or extensive disease surgical treatment can be considered There are two classic surgical techniques The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type The second classic surgical technique is the Longo stapled anopexy Recently less invasive surgical techniques such as arterial ligation HAL with or without Doppler followed by recto-anal repair RAR for Recto Anal Repair and sometimes associated with mucopexy which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall have developed The use of radiofrequency current Rafaelo technique in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation It is a mini-invasive technique which can be performed under sedation or short general anaesthesia GA with little pain allowing a rapid return to normal life and a short time off work Although this technique is already used in other European countries Poland Germany Belgium Great Britain UK there is now a Polish German Spanish and English study in the process of publication There have been no studies in France to evaluate this new technique and assess its good tolerance the duration of work stoppage the improvement in quality of life and the evaluation of its effectiveness
Detailed Description:
None
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