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

Recruiting

• Conditions: fistula; fistula in ano; perianal fistula; 10069888; 10017998

• Registration Number: NL-OMON50540
• Lead Sponsor: Heelkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 73

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Changes in anorectal function measured with 3D-HRAM before and after<br /><br>fistulotomy<br /><br>2. Changes in continence and soiling between preoperative and 4 and 12 months<br /><br>postoperative. Measured with patient reported outcome measurements: FiQL,<br /><br>Wexner and ProctoPROM.<br /><br>3. Correlation between 1 and 2</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To analyze sphincter defects with the EAUS examination and correlate this<br /><br>with the pressure-profile measured by 3D-HRAM.<br /><br>2. To establish possible prognostic factors for deterioration in anorectal<br /><br>function and fecal incontinence in patients who underwent fistulotomy</p><br>