Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Brief Title:
Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
VAAFT-OTSC
Brief Summary:
This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment Additionally the internal opening of the fistulae will be closed by an OTSC clip
Detailed Description:
Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason Anteriorly located high and trans-sphincteric fistulae are at more risk
Ablating the fistula tract by laser or diathermy has been in use for a long time Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe Recently closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence The success rate was higher when the opening was closed by a stapler device
Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods
Ablating the fistula tract by laser or diathermy has been in use for a long time Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe Recently closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence The success rate was higher when the opening was closed by a stapler device
Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods
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