A prospective randomised controlled trial in the treatment of anal fissures; Botulin-A Toxin versus Topical Diltiazem: BOTTOM-trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29443

Enrollment

164

Registered

2007-07-02

Start date

2005-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal fissure (NLD: anale fissuur).

Interventions

Botuline A injection (once) -Topical Diltiazem application (3-6 months).

Eligibility

Inclusion criteria

Inclusion criteria: Chronic anal fissure, without previous therapy.

Exclusion criteria

Exclusion criteria: 1. Allergy to botuline A toxine and Diltiazem; 2. Cardiovascular disease: a. sever hypotension; b. bradycardia; c. heart failure; d. cardiogenic shock; e. sever aortastenosis; f. second or third degree AV-block; g. “sick sinus” syndroom; h. Wolff-Parkinson-White-syndroom; i. atrialfibrillation or flutter; 3. Myocardial infraction; 4. Neuromusculair dysfunction: myasthenia gravis or myasthenie (Eaton-Lambert syndrome), ALS.

Design outcomes

Primary

Measure	Time frame
Healing of fissure.	—

Secondary

Measure	Time frame
Costs and adverse events.	—

Contacts

Public ContactB.A. Twigt

Bosboomstraat 1

bastwigt@hotmail.com0031302566067

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)