Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604483
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-10-14
Brief Title:
Percutaneous Tibial Nerve Stimulation PTNS for the Treatment of Chronic Anal Fissure
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Chronic anal fissure rarely heals spontaneously About 50 heal on administration om topical muscle relaxants eg diltiazem andor injection of Botulinum toxin but for the remainder of patients surgery with lateral internal sphincterotomy or fissurectomy with subsequent risks of anal incontinence has been the golden standard Treatment with PTNS percutaneous tibial nerve stimulation has been showed to produce healing of chronic anal fissures not responding to topical treatment thus avoiding the risk for debilitating anal incontinence
Detailed Description:
This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months If the patients symptoms are unimproved at 3 months alternative treatments will be offered
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