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 ]

Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).


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