Long-term Follow-up of Anal Fistula Plug

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT03961984

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anal Fistula	Procedure: Biodesign® anal fistula plug

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 Design

Study Type:

Observational

Actual Enrollment :

95 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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