Long-term Follow-up of Anal Fistula Plug

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03961984

Enrollment

Registered

2019-05-23

Start date

2006-05-31

Completion date

2009-10-31

Last updated

2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Keywords

anal fistula, fistula-in-ano, surgical plug, collagen plug, complex anal fistula, transsphincteric anal fistula

Brief summary

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

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

PROCEDUREBiodesign® 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* complex transsphincteric anal fistula

Exclusion criteria

* ano/rectovaginal fistula

Design outcomes

Primary

Measure	Time frame	Description
Fistula recurrence; Technical failure	Week 2	Plug fallen out
Fistula recurrence; Infection	Week 2	Surgical site infection
Fistula recurrence; New opening	Week 2	Faeces coming through external opening

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026