Étude Monocentrique de faisabilité d'un Nouveau Dispositif Pour le Traitement de la Fissure Anale Par Toxine Botulique (FR) Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin (EN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Feasibility of the injection of the botulin toxin with the device under investigation
Study Overview
Brief Summary
Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.
Detailed Description
Anal fissure is a common anal disease. This is a longitudinal tear in the distal part of the anal canal. The fissure provokes a spasm of the internal anal sphincter and as such pain and eventually bleeding.
There are currently 3 different treatments. All available treatments tend to relax the anal sphincter, which reduces pain and promotes fissure healing.
The first treatment consists in the local application of cream into the anal canal.
The second option is the injection of botulinum toxin into the internal or external anal sphincter. Finally the third option is a surgical intervention, most frequently a lateral sphincterotomy.
Although the usefulness of botulinum toxin to treat anal fissure has been demonstrated, the results vary. This is most likely largely due to the fact that there is no standardized way to inject botulinum toxin and that there is a significant learning curve. In addition, the gesture is not without risk for the operator.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients suffering from anal fissures for a minimum of 6 weeks.
- •informed consent signed
Exclusion Criteria
- •Contraindication to the use of botulinum toxin or any known allergies
- •Pregnant or breastfeeding women
- •Immune deficiency, immunosuppression
- •Anticoagulant treatment
- •Previous pelvic radiotherapy
- •Acute anal inflammation (eg.proctitis)
- •Internal hemorrhoids of grade 2 or higher
- •Anal fissure that did not respond to a previous treatment by botulinum toxin
- •History of lateral sphincterotomy
- •Cardiopulmonary disease leading to reduced function of the Cardiopulmonary system
Outcomes
Primary Outcomes
Feasibility of the injection of the botulin toxin with the device under investigation
Time Frame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
The operator shall answer by yes or no. If yes, the procedure is further assessed (see outcome 2)
Secondary Outcomes
- Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks(day 1, day +7, day +56)
- Assessment of the relaxation of the internal anal sphincter(day 1, day +7, day +56)
- Assessment of the patient's tolerance: visual analogic scale (VAS)(This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).)
- Assessment of the healing rate(day 1, day +56)
- Assessment of the procedure by the operator(This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).)
- Assessment of the incontinence(day 1, day +7, day +56)
Investigators
Dieter Hahnloser
Professor
University of Lausanne Hospitals