Clinical Trial: Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial

Brief Summary:

Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common and generally associated with pain, anal incontinence, impaired quality of life and work incapacity. The therapeutic management of this disease has a double objective: heal the suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000 in the normal population, with a difference in prevalence between men and women (1.23 per 10 000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et al., 2012).

In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses' anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an abscess between the internal and external sphincters, which in turn can spread to other parts of the perianal region. The infection can follow many directions from this point in the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula therefore has always an intraductal origin, cryptic, with a primary port at this level, and the disregard of which causes the recurrence of the fistula; and usually a secondary port in the skin.

Fistulas are usually divided into two groups. The first group contains fistulas called "simple", which are intersphincteric fistulas or trans-sphincteric involving only the lower third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group contains fistulas called "complex". These are intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric fistulas.

For many years, the treatment of choice was to open the fistula (fistulotomy), but this procedure was associated with a risk of incontinence, the consequences could b

Detailed Summary:

After validation of the inclusion and exclusion criteria, the patients included in this clinical trial will be randomized between the two arms of the study for the closure of the anal fistula:

  • Control group: advancement flap technique Experimental group: closure clip (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners)

Follow up of the patients will be performed until 1 year after the intervention.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Proportion of patients with healed anal fistula [ Time Frame: at 3 months after surgery ]

The diagnosis will be made by the lack of leakage alleged by the patient for at least one month and found on clinical examination


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anal fistula healing [ Time Frame: at 6 months and 1 year ]
  • VAS proctologic pain [ Time Frame: days 0, 1, 2, 3, 15, 30, 60, 90, 180 and 365 ]
  • Anal incontinence score (questionnaire Jorge and Wexner) [ Time Frame: days 0, 15, 30, 60, 90, 180 and 365 ]
  • Digestive disorders and quality of life (GIQLI questionnaire) [ Time Frame: days 0, 15, 30, 60, 90, 180 and 365 ]
  • Quality of life (EQ5D Questionnaire) [ Time Frame: days 0, 30, 90, 365 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: January 8, 2015
Date Started: January 2015
Date Completion: February 2017
Last Updated: September 18, 2015
Last Verified: September 2015