Long-term Follow-up of Anal Fistula Plug

Overview

Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.

Full Title of Study: “Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2009

Detailed Description

A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 – October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.

Interventions

  • Procedure: Biodesign® anal fistula plug
    • Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage.

Arms, Groups and Cohorts

  • Complex anal fistula
    • Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug.

Clinical Trial Outcome Measures

Primary Measures

  • Fistula recurrence; Technical failure
    • Time Frame: Week 2
    • Plug fallen out
  • Fistula recurrence; Infection
    • Time Frame: Week 2
    • Surgical site infection
  • Fistula recurrence; Infection
    • Time Frame: Month 3
    • Surgical site infection
  • Fistula recurrence; Infection
    • Time Frame: Month 6-12
    • Surgical site infection
  • Fistula recurrence; Infection
    • Time Frame: Through study completion, an average of 8 years
    • Surgical site infection
  • Fistula recurrence; New opening
    • Time Frame: Week 2
    • Faeces coming through external opening
  • Fistula recurrence; New opening
    • Time Frame: Month 3
    • Faeces coming through external opening
  • Fistula recurrence; New opening
    • Time Frame: Month 6-12
    • Faeces coming through external opening
  • Fistula recurrence; New opening
    • Time Frame: Through study completion, an average of 8 years
    • Faeces coming through external opening

Participating in This Clinical Trial

Inclusion Criteria

  • complex transsphincteric anal fistula Exclusion Criteria:

  • ano/rectovaginal fistula

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Skane
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marianne Starck, MD, PhD, Study Chair, Region Skane

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