Pelvic floor therapy in the treatment of all anal fissures; a multicentre, randomized controlled trial
Recruiting
- Conditions
- anal ulcer1000211210017998anal tear
- Registration Number
- NL-OMON40264
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
Patients, at least 18 years of age or older with an acute or chronic anal fissure
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is pain. Pain will be measured by the VAS score. Patients<br /><br>are asked to draw a vertical line on a horizontal line of exactly 10<br /><br>centimeters long. That line will only be number on the left side, with a 0 and<br /><br>on the right side with a 10. After participants have drawn their line, the<br /><br>researcher will measure in millimeters what their score is.<br /><br><br /><br>Measurement moments are baseline and after treatment starts on day 1, 2, 3, and<br /><br>after 1, 2, 4, 8 and 12 weeks.<br /><br><br /><br>Mean score will be compared between intervention and controlgroup</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome is healing after 8 weeks. Healing will be assessed by the<br /><br>surgeon. Healing is defined as closure of the anal fissure.<br /><br><br /><br>Secondary outcome is whether or not the fissure is still healed after 12 weeks.<br /><br>This will again be assessed by the surgeon. Healing is defined complete closure<br /><br>of the anal fissure.<br /><br><br /><br>Portion of healed fissures will be compared between intervention and<br /><br>controlgroup.</p><br>