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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Skane 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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