Anal Fistula
Conditions
Keywords
VAAFT, anal fistula, sphincter reconstruction
Brief summary
This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.
Detailed description
The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.
Interventions
PROCEDUREoperation
the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.
DEVICEVAAFT
Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.
Sponsors
Odense University Hospital
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with complex transsphincteric anal fistulas \>18 yrs old.
Exclusion criteria
* Crohns fistulas * Signs of suppuration or/and branching. * Malignancy within 5 yrs. * Previous radiotherapy of the abdomen and pelvis. * Current Immune- suppressive treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recurrence rate of perianal fistula | 6 months | A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in quality of life score | baseline and 6 months | A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. |
| changes in fecal incontinence score | baseline and 6 months | A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. |
| changes in manometric study | baseline and 6 months | A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant. |
Countries
Denmark
Outcome results
None listed