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Completed

NCT Number: NCT03961984

Long-term Follow-up of Anal Fistula Plug

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

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Malmö, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • complex transsphincteric anal fistula

Exclusion criteria

  • ano/rectovaginal fistula

Treatment and study plan

Biodesign® anal fistula plug

Procedure

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

Primary outcomes

  1. Fistula recurrence; Technical failure

    Time frame: Week 2

    Plug fallen out

  2. Fistula recurrence; Infection

    Time frame: Week 2

    Surgical site infection

  3. Fistula recurrence; Infection

    Time frame: Month 3

    Surgical site infection

  4. Fistula recurrence; Infection

    Time frame: Month 6-12

    Surgical site infection

  5. Fistula recurrence; Infection

    Time frame: Through study completion, an average of 8 years

    Surgical site infection

  6. Fistula recurrence; New opening

    Time frame: Week 2

    Faeces coming through external opening

  7. Fistula recurrence; New opening

    Time frame: Month 3

    Faeces coming through external opening

  8. Fistula recurrence; New opening

    Time frame: Month 6-12

    Faeces coming through external opening

  9. Fistula recurrence; New opening

    Time frame: Through study completion, an average of 8 years

    Faeces coming through external opening

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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