Value of 3D Anal Manometry in anal Fistula Surgery: AMFI study

Value of 3D Anal Manometry in anal Fistula Surgery: AMFI study - AMFI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50540

Enrollment

Registered

2021-12-13

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fistula fistula in ano perianal fistula

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age between 18-80 years - Planned to undergo fistulotomy - Suitable for e-mail questionnaires - Sufficient understanding of the Dutch written language (reading and writing) - Obtained written informed consent

Exclusion criteria

Exclusion criteria: - Non cryptoglandular fistulae (Crohn*s disease e.a.) - Prior rectal radiation - Rectovaginal fistulae - ASA 3-4 (patients who cannot undergo surgery in our clinic)

Design outcomes

Primary

Measure	Time frame
1. Changes in anorectal function measured with 3D-HRAM before and after fistulotomy 2. Changes in continence and soiling between preoperative and 4 and 12 months postoperative. Measured with patient reported outcome measurements: FiQL, Wexner and ProctoPROM. 3. Correlation between 1 and 2	—

Secondary

Measure	Time frame
1. To analyze sphincter defects with the EAUS examination and correlate this with the pressure-profile measured by 3D-HRAM. 2. To establish possible prognostic factors for deterioration in anorectal function and fecal incontinence in patients who underwent fistulotomy	—

Countries

Netherlands

Outcome results