Clinical trial NCT04173130: Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fissure
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

The objective of the study is to assess the feasibility of injecting botulinum toxin into the anal canal with a new medical device for patients with anal fissure.

The trial is a mono-centric pilot study conducted on 4 patients. The study is open, prospective and all patients will be treated with the botulinum toxin injected using the new medical device.

The device (single-use) under investigation and the botulinum toxin will be made available free of charge to the patient.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the injection of the botulin toxin with the device under investigation
timeFrame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
Secondary outcomes:
measure: Assessment of the procedure by the operator
timeFrame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
measure: Assessment of the patient's tolerance: visual analogic scale (VAS)
timeFrame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).
measure: Assessment of the relaxation of the internal anal sphincter
timeFrame: day 1, day +7, day +56
measure: Assessment of the incontinence
timeFrame: day 1, day +7, day +56
measure: Assessment of the healing rate
timeFrame: day 1, day +56
measure: Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks
timeFrame: day 1, day +7, day +56
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne Universitary Hospital (CHUV)
state: Vaud
Study officials:
affiliation: Lausanne Universitaire Hospital (CHUV)
name: Dieter Hahnloser, Prof.
role: PRINCIPAL_INVESTIGATOR
References: