Monocentric Feasibility Study for a New Medical Device for the Treatment of Anal Fissure With Botulinum Toxin

Dieter Hahnloser

Status: Completed

Conditions: Anal Fissure

Treatments: Device: Anuscope with needles

Study type: Interventional

Funder types: Other

Identifiers

NCT04173130

DIT_Anuscope_2019

Details and patient eligibility

About

Monocentric feasibility study for a new device for the treatment of anal fissure with botulinum toxin.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Injection of botulinum toxin with investigational device

Experimental group

Treatment:

Device: Anuscope with needles