Long-term Follow-up of Anal Fistula Plug

May 22, 2019 updated by: Region Skane

Long-term Follow-up of Anal Fistula Plug for Treatment of Complex Trans-sphincteric Fistulas

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmo, Sweden
        • Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with anal fistulas not treatable with a simple fistulotomy offered to participate.

Description

Inclusion Criteria:

  • complex transsphincteric anal fistula

Exclusion Criteria:

  • ano/rectovaginal fistula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complex anal fistula
Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug.
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.
Other Names:
  • Surgisis anal fistula plug
  • Collagen plug

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Chair: Marianne Starck, MD, PhD, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Plug follow-up 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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