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Pelvic floor physiotherapy in treatment of Chronic Anal Fissure (PAF-study)

Pelvic floor physiotherapy in treatment of Chronic Anal Fissure, a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27503
Enrollment
133
Registered
2018-10-25
Start date
2018-12-01
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

chronic anal fissure pelvic floor dysfunction dyssynergia treatment chronische anale fissuur bekkenbodemdysfunctie dyssynergie behandeling

Interventions

Interventiongroup Pelvic Floor Physiotherapy (PFMT)including biofeedback following a standardized treatmentprotocol Controlgroup: delayed PFMT including biofeedback following a standardized treatment

Sponsors

Proctos Clinics Bilthoven Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • All patients > 18 years old • Chronic anal fissure(anal fissure existing longer than 6 weeks) and pelvic floor dysfunction

Exclusion criteria

Exclusion criteria: • Patients presenting an abscess or fistula • Patients with Crohn’s disease or ulcerative colitis; • Patients who received prior anal radiation therapy; • Patients with diagnosed anorectal malignancy

Design outcomes

Primary

MeasureTime frame
VAS-scores(pain) Quality of life

Secondary

MeasureTime frame
- Prevalence of pelvic floor dysfunction in chronic anal fissure measured by physical examination and balloon expulsion test - Difference in EMG signals of the pelvic floor before and after treatment; - Relation between chronic anal fissures and other pelvic floor dysfunctions; -PROM before and after PFMT

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)