Pelvic Floor Physiotherapy in chronic anal fissure

Pelvic Floor Physiotherapy in chronic anal fissure - PAF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50721

Enrollment

140

Registered

2018-10-12

Start date

2018-12-10

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

anal gap

Interventions

Rectal toucher/exam and biofeedback with an anal probe.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: all patients above 18 years old with a chronic anal fissure with pelvic floor dysfunction

Exclusion criteria

Exclusion criteria: Patients presenting with perianal abces or fistula Patients presenting with Chrohns disease or colitis ulcerosa Patients who received prior anal radiation therapy Patients with anorectal malignancy

Design outcomes

Primary

Measure	Time frame
- The tone at rest during EMG registration of the pelvic floor before and after therapy	—

Secondary

Measure	Time frame
- Prevalence of pelvic floor dysfunction in chronic anal fissure measured by physical examination, balloon expulsion test - Relation between anal fissure and other pelvic floor dysfunctions - Proctoprom at the start of the study, after 8 weeks, 20 weeks and one year follow up - Difference in EMG signals of the pelvic floor after pelvic floor physiotherapy for tone at rest, MVC and Endurance at the start of the study, after weeks, 20 weeks and one year follow up - Quality of life as measured by scores of the domains of the RAND-36 questionnaire, at the start of the study, after 8 weeks, 20 weeks and one year follow up - The efficacy of PFPT with biofeedback and/or electro stimulation - VAS- pain score at the start of the study, after 8 weeks, 20 weeks and one year follow up	—

Measure

Time frame

- Prevalence of pelvic floor dysfunction in chronic anal fissure measured by physical examination, balloon expulsion test - Relation between anal fissure and other pelvic floor dysfunctions - Proctoprom at the start of the study, after 8 weeks, 20 weeks and one year follow up - Difference in EMG signals of the pelvic floor after pelvic floor physiotherapy for tone at rest, MVC and Endurance at the start of the study, after weeks, 20 weeks and one year follow up - Quality of life as measured by scores of the domains of the RAND-36 questionnaire, at the start of the study, after 8 weeks, 20 weeks and one year follow up - The efficacy of PFPT with biofeedback and/or electro stimulation - VAS- pain score at the start of the study, after 8 weeks, 20 weeks and one year follow up

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)