Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
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
OBSERVATIONAL
Enrollment
95
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.
Skåne University Hospital
Malmo, Sweden
Fistula recurrence; Technical failure
Plug fallen out
Time frame: Week 2
Fistula recurrence; Infection
Surgical site infection
Time frame: Week 2
Fistula recurrence; Infection
Surgical site infection
Time frame: Month 3
Fistula recurrence; Infection
Surgical site infection
Time frame: Month 6-12
Fistula recurrence; Infection
Surgical site infection
Time frame: Through study completion, an average of 8 years
Fistula recurrence; New opening
Faeces coming through external opening
Time frame: Week 2
Fistula recurrence; New opening
Faeces coming through external opening
Time frame: Month 3
Fistula recurrence; New opening
Faeces coming through external opening
Time frame: Month 6-12
Fistula recurrence; New opening
Faeces coming through external opening
Time frame: Through study completion, an average of 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.