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The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas.

The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22310
Enrollment
60
Registered
2007-06-07
Start date
2006-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Perianal fistula

Interventions

Installation of the anal fistula plug.

Sponsors

Academic Medical Centre meibergdreef 9 1105 AZ Amsterdam +31-205669111
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. High anorectal fistula of cryptoglandular origin (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal); 2. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Age<18 years; 2. HIV-positive; 3. Crohn´s disease; 4. Malignant cause; 5. Tuberculosis; 6. Hidradenitis suppurativa; 7. Pilonidal sinus disease; 8. No internal opening found during surgery.

Design outcomes

Primary

MeasureTime frame
1. Anorectal fistula closure rate; 2. Continence.

Secondary

MeasureTime frame
1. Morbidity; 2. Post-operative pain; 3. Sick leave; 4. Quality of life.

Contacts

Public ContactJ.F.M. Slors

AMC, Afd. Chirurgie

j.f.slors@amc.uva.nl+3120-5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)