Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548724
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-11-09
Brief Title:
Patients Quality of Life and Functional Changes After Fistula Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patients Quality of Life and Functional Changes After Fistula Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational study that will monitor the effects of surgery for anal fistula on the patient quality of life using many valid questionnaires
Detailed Description:
Anal fistulas can be classified as simple or complex Simple anal fistula includes low trans-sphincteric and intersphincteric fistulas that cross less than 30 of the external sphincter fibers On the other hand complex anal fistulas comprise high trans-sphincteric fistulas suprasphincteric extrasphincteric fistulas
Patients with anal fistula often complain of recurrent perianal discharge and pruritus ani Sometimes recurrent abscesses develop due occlusion of the external opening leading to episodes of fever and exquisite perianal pain Diagnostic modalities that aid in the diagnosis of anal fistula include fistulography endorectal ultrasonography MR Fistulography
While the treatment of simple anal fistula is usually straightforward with fistulotomy being recommended as the first line of treatment the management of more complex cases requires more sophisticated treatments aiming to preserve the anal sphincters and to eradicate the fistulous track Surgery for complex anal fistula includes the placement of Seton anal advancement flap laser ablation fistula plug and video-assisted anal fistula treatment There exists a debate about the optimal management of low anal fistula with both fistulectomy and fistulotomy considered as viable options for treatment Fistulectomy involves complete excision of the fistulous tract eliminating the risk of missing secondary tracts and providing complete tissue for histopathological examination On the other hand fistulotomy involves lay open of the fistulous tract thus leaving smaller unepithelized wounds which hastens the wound healing A recent meta-analysis found no significant difference between both procedures regarding recurrence of anal fistula yet with accelerated healing time in favor of fistulotomy Recently alternative therapies have been employed in the management of cryptogenic anal fistula in an attempt to render the surgery more minimally invasive and to reduce the likelihood of post-operative fecal incontinence
These treatments have included ligation of the intersphincteric fistula tract the LIFT procedure either with or without the deployment of a biosynthetic mesh or fistula clip closure techniques and a range of endo-fistula therapies including video-assisted anal fistula treatment VAAFT anal fistula plugs and a variety of injected biomaterials
The Fistula Laser Closing FiLaCTM device Biolitec Germany is another endo-fistula management technique There is few studies assessing the changes in quality of life that occurs after fistula surgery whatever its technique and the aim of this study is t assess the impact of intervention for fistula on patients quality of life
Patients with anal fistula often complain of recurrent perianal discharge and pruritus ani Sometimes recurrent abscesses develop due occlusion of the external opening leading to episodes of fever and exquisite perianal pain Diagnostic modalities that aid in the diagnosis of anal fistula include fistulography endorectal ultrasonography MR Fistulography
While the treatment of simple anal fistula is usually straightforward with fistulotomy being recommended as the first line of treatment the management of more complex cases requires more sophisticated treatments aiming to preserve the anal sphincters and to eradicate the fistulous track Surgery for complex anal fistula includes the placement of Seton anal advancement flap laser ablation fistula plug and video-assisted anal fistula treatment There exists a debate about the optimal management of low anal fistula with both fistulectomy and fistulotomy considered as viable options for treatment Fistulectomy involves complete excision of the fistulous tract eliminating the risk of missing secondary tracts and providing complete tissue for histopathological examination On the other hand fistulotomy involves lay open of the fistulous tract thus leaving smaller unepithelized wounds which hastens the wound healing A recent meta-analysis found no significant difference between both procedures regarding recurrence of anal fistula yet with accelerated healing time in favor of fistulotomy Recently alternative therapies have been employed in the management of cryptogenic anal fistula in an attempt to render the surgery more minimally invasive and to reduce the likelihood of post-operative fecal incontinence
These treatments have included ligation of the intersphincteric fistula tract the LIFT procedure either with or without the deployment of a biosynthetic mesh or fistula clip closure techniques and a range of endo-fistula therapies including video-assisted anal fistula treatment VAAFT anal fistula plugs and a variety of injected biomaterials
The Fistula Laser Closing FiLaCTM device Biolitec Germany is another endo-fistula management technique There is few studies assessing the changes in quality of life that occurs after fistula surgery whatever its technique and the aim of this study is t assess the impact of intervention for fistula on patients quality of life
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