Clinical trial NCT02585167: Endoscopic Treatment of Complex Anal Fistulas
Official title: Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anal Fistula
Keywords: VAAFT
anal fistula
sphincter reconstruction
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2015-10-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

Detailed description: The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients with complex transsphincteric anal fistulas \>18 yrs old.

Exclusion Criteria:

* Crohns fistulas
* Signs of suppuration or/and branching.
* Malignancy within 5 yrs.
* Previous radiotherapy of the abdomen and pelvis.
* Current Immune- suppressive treatment.

Primary outcomes:
measure: The recurrence rate of perianal fistula
timeFrame: 6 months
Secondary outcomes:
measure: changes in quality of life score
timeFrame: baseline and 6 months
measure: changes in fecal incontinence score
timeFrame: baseline and 6 months
measure: changes in manometric study
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
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