Clinical Trial: Treatment Of Chronic Anal Fissure
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment Of Chronic Anal Fissure (TOCA): a Randomized Clinical Trial on Levorag® Emulgel Versus Diltiazem Gel 2%
Brief Summary: The purpose of this study is to investigate the effect of Levorag Emulgel compared with diltiazem gel on the healing of chronic anal fissures.
Detailed Summary:
Anal fissure is an ulcer-like, longitudinal tear in the anal canal, most commonly located in the dorsal or ventral midline, and distal to the dentate line. Anal fissures constitute a common medical problem that affects sexes equally. The initiation of the fissure is most likely caused by the passage of hard stools that traumatizes the anal canal. Patients suffer from anal pain lasting up to several hours after defecation and rectal bleeding.3 Most acute anal fissures heal spontaneously, but a proportion progress into chronic fissures with symptoms beyond 8-12 weeks. There is no strict definition of a chronic anal fissure, but previously the presence of two of the following three symptoms has been used:
- Pain after defecation lasting for more than three months;
- presence of a sentinel anal tag; and
- Exposure of the horizontal fibres of the internal anal sphincter. The severe pain may be caused by a hypertonic contraction of the internal anal sphincter leading to ischemia. Treatment strategies have therefore aimed to relieve this hypertonia by surgical and non-operative approaches. Primary therapy is initiated with ointments such as Diltiazem and glyceryltrinitrat gels.
A novel approach is the Levorag® Emulgel, an ointment classified as Medical Device class 1. According to the manufacturer (THD SpA, Italy) the effect of Levorag® Emulgel is mediated through the effects of myoxinol, a plant extract from the Hibiscus plant with a botox-like effects on the anal sphincter and carboxymethyl glucan, a natural yeast polysaccharide with immune stimulating properties. The effect of the widely used Diltiazem gel, is mediated through diltiazem hydrochloride, a calcium channel blocker that decreases the anal sphincter press
Sponsor: Bispebjerg Hospital
Current Primary Outcome: Complete healing at week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Complete healing at week 8 [ Time Frame: 8 weeks ]Complete healing of the anal fissure after 8 weeks
- Defecation pain at day 3 [ Time Frame: 3 days ]Perianal pain at or after defecation at day 3
- Defecation pain at day 7 [ Time Frame: 7 days ]Perianal pain at or after defecation at day 7
- Adverse events [ Time Frame: 12 weeks ]Any adverse events recorded during the study period
Original Secondary Outcome: Same as current
Information By: Bispebjerg Hospital
Dates:
Date Received: June 5, 2014
Date Started: September 2014
Date Completion: June 2018
Last Updated: July 25, 2016
Last Verified: July 2016
