Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02372981
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2015-02-06
Brief Title:
Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs Suture Mucopexy Alone
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs Suture Mucopexy Alone for the Treatment of Grade III Haemorrhoids A Prospective-randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-02
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:
Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise the drawbacks of the golden standard of haemorrhoidal treatment conventional haemorrhoidectomy techniques Ligation techniques such as Doppler-guided haemorrhoidal artery ligation DG-HAL were introduced to reduce the arterial inflow of the AVP and thus prevent the haemorrhoidal zone from being part of the continence system Apart from inappropriate application of this surgical alternative for higher grade haemorrhoids high recurrence rates of up to 38 after DG-HAL are due to technical failure of the ligation technique itself This is a prospective randomised controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with symptomatic grade III haemorrhoids
Detailed Description:
All consecutive patients with symptomatic grade III haemorrhoids are randomly allocated to one of the two study arms A DG-HAL with mucopexy or B mucopexy alone Endpoints are pain faecal incontinence bleeding residual prolapse and vascularisation of the anorectal vascular plexus Vascularisation of the anorectal vascular plexus is assessed by transperineal contrast enhanced ultrasound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None