anal fistula, anorectal fistula, perianal fistula, cryptoglandular fistula, seton drainage anal fistula
Conditions
Interventions
Group A: 
Patients receive a loose seton prior to definitive fistula surgery (two-stage procedure), which is currently considered standard care in the Netherlands.Group B: Patients proceed directly to definitiv
Sponsors
Proctos Kliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men and women aged 18 years or olderSingle tract mid-high or high cryptoglandular anal fistulaEligible for e-mail questionnairesSufficient understanding of the Dutch written language (reading and writing)Obtained written informed consent
Exclusion criteria
Exclusion criteria: Presence of an anorectal abscessMultiple or complex anorectal fistulasDiagnosis of inflammatory bowel diseaseHistory of anorectal malignancyUse of immunosuppressive medication at the time of surgeryHistory of pelvic radiationPregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of the study is fistula closure at 26 weeks following the final surgical intervention. Determined through the absence of fistula related symptoms (pain and/or leakage of fluids or pus) and if necessary confirmed with ultrasound or MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcome measures (PROMs): Vaizey incontinence score and FIQL (Fecal Incontinence Quality of Life scale)Clinical outcomes: fistula recurrence, postoperative complications, need for re-interventions, pain intensity (VAS score), return to workQuality of life: Measured at 12 months using the EQ-5D-5LBoth in-hospital direct and indirect costs will be analyzed using EQ-5D and incremental cost analysisOut-of-hospital postoperative costs will also be includedAnal Fistula Core Outcome Set (AFCOS) | — |
Countries
Netherlands
Contacts
Public ContactA.A. Elwakel
Amsterdam UMC
Outcome results
None listed