Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386835
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Brief Title:
Collagen Paste vs Mucosal Advancement Flap for FIA
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano Single Centre Non-inferiority Randomised Controlled Trial
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:
The treatment for fistula-in-ano FIA remains a challenge to General and Colorectal Surgeons Worldwide A variety of surgical treatments have been described for high anal fistulas but none offers the panacea of fistula eradication with guaranteed preservation of continence This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano
Detailed Description:
Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle With this technique it shows promising results with success rate of approximately 60 However complications have been reported in particular with a change of continence in 30-35 of patients
Collagen paste is a novel sphincter-preserving method for fistula closure Permacol Medtronic USA is a sterile acellular cross-linked porcine dermal collagen matrix suspension The paste-like suspension form a matrix that accelerates neovascularization cellular infiltration which promotes healing and fistula closure The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement Limited data is available to date Success rates of collagen paste range from 476 to 63 Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex
Collagen paste is a novel sphincter-preserving method for fistula closure Permacol Medtronic USA is a sterile acellular cross-linked porcine dermal collagen matrix suspension The paste-like suspension form a matrix that accelerates neovascularization cellular infiltration which promotes healing and fistula closure The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement Limited data is available to date Success rates of collagen paste range from 476 to 63 Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex
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