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NCT Number: NCT04173130

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

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

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Key information

Conditions

Anal Fissure Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lausanne Universitary Hospital (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anuscope with needles

Device

Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).

Primary outcomes

  1. 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

  1. Assessment of the procedure by the operator

    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 will assess the procedure by answering the following questions:

    How was the introduction of the anuscope ? easy-neither easy nor difficult-difficult.

    How was the positioning of the anuscope? easy-neither easy nor difficult-difficult.

    How was the deployment of the needles? easy-neither easy nor difficult-difficult.

    How was the injection of the toxin? easy-neither easy nor difficult-difficult. How was the needles retraction? easy-neither easy nor difficult-difficult.

  2. Assessment of the patient's tolerance: visual analogic scale (VAS)

    Time frame: This outcome will be assessed right after the use of the device under investigation, at day 1 (day of the intervention).

    Patient assessment using a visual analogic scale (0 to 10, 0 not tolerated at all, 10 well tolerated)

  3. Assessment of the relaxation of the internal anal sphincter

    Time frame: day 1, day +7, day +56

    Measurement of the relaxation using MAPLe

  4. Assessment of the incontinence

    Time frame: day 1, day +7, day +56

    Score of Vaizey (0 minimum score, perfect continence; 24 = maximum score, totally incontinent)

  5. Assessment of the healing rate

    Time frame: day 1, day +56

    Assessment according to the Lindsey criteria

  6. Safety of the procedure by assessing adverse events, device deficiencies and identifying new risks

    Time frame: day 1, day +7, day +56

    Safety of the procedure by assessing adverse events (description of adverse events, number of participants), device deficiencies (description of the deficiency) and identifying new risks

Sponsors and collaborators

Lead sponsor

Dieter Hahnloser

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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