Long-term Follow-up of Anal Fistula Plug

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961984
• Other study ID #: Plug follow-up 2006
• Status: Completed
• Start date: May 2006
• Est. completion date: October 2009

Study information

• Verified date: May 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• complex transsphincteric anal fistula

Exclusion Criteria:

• ano/rectovaginal fistula

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

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