Clinical Trial: Treatment of Anal Fistula With Lasercoagulation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
Brief Summary: The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
Detailed Summary: Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.
Sponsor: Region Skane
Current Primary Outcome: Healing [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Infection [ Time Frame: 12 months ]Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.
- Incontinence [ Time Frame: 12 months ]Presence of fecal incontinence as described by the patient
Original Secondary Outcome: Same as current
Information By: Region Skane
Dates:
Date Received: January 9, 2017
Date Started: March 3, 2017
Date Completion: March 2018
Last Updated: March 3, 2017
Last Verified: January 2017