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Pelvic floor therapy in the treatment of all anal fissures; a multicentre, randomized controlled trial

Pelvic floor therapy in the treatment of all anal fissures; a multicentre, randomized controlled trial - FIP-trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40264
Enrollment
140
Registered
2013-11-29
Start date
2014-01-08
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

anal tear anal ulcer

Interventions

Pelvic floor therapy. Consisting out of a weekly course for 3 weeks. Each session takes about 30 minutes. General queries are asked to evaluate the pelvic floor and general information is given abou

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients, at least 18 years of age or older with an acute or chronic anal fissure

Exclusion criteria

Exclusion criteria: Inflammatory bowel disease, malignancy, HIV/AIDS, Anal abscess or fistulae, low sphincter tension, previous surgical intervention for anal fissure, patients using chronic pain medication, patients with a traumatic anal fissure

Design outcomes

Primary

MeasureTime frame
The primary outcome is pain. Pain will be measured by the VAS score. Patients are asked to draw a vertical line on a horizontal line of exactly 10 centimeters long. That line will only be number on the left side, with a 0 and on the right side with a 10. After participants have drawn their line, the researcher will measure in millimeters what their score is. Measurement moments are baseline and after treatment starts on day 1, 2, 3, and after 1, 2, 4, 8 and 12 weeks. Mean score will be compared between intervention and controlgroup

Secondary

MeasureTime frame
Secondary outcome is healing after 8 weeks. Healing will be assessed by the surgeon. Healing is defined as closure of the anal fissure. Secondary outcome is whether or not the fissure is still healed after 12 weeks. This will again be assessed by the surgeon. Healing is defined complete closure of the anal fissure. Portion of healed fissures will be compared between intervention and controlgroup.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)