Permacol for treating anal fistulae

Fabiani et al. 2017

Study size, design and location

Case series in 21 consecutive patients having treatment for complex anal fistulae. Located in Italy.

Intervention and comparator(s)

All patients had fistulectomy and seton 6 to 8 weeks before the trial. All patients had endoscopic ultrasonography and/or MRI before Permacol.

Key outcomes

Continence was evaluated before (0.33±0.57) and 12 months after Permacol injection (0.61±1.02) using the faecal incontinence severity index. There was no significant difference between these 2 scores (p=0.27) and no reported worsening of continence.

Postoperative pain was measured using the visual analogue scale; none of the patients reported severe pain (VAS score >7).

Mean operative time was 30 minutes and median hospital stay was 1 day.

At 12-months follow-up, 10 patients (including 1 with Crohn's disease) had a closed external orifice and were considered to be healed, providing a success rate of 47.6%.

Strengths and limitations

Permacol was used alongside fistulectomy and draining seton, meaning that any results may not be because of Permacol alone. It should also be noted that only complex fistulae were treated in this study. The study shows that Permacol is safe and well tolerated.

Ahmad et al. (2015)

Study size, design and location

Case series in 11 patients with anal fistulae (12 fistulae in total). Located in UK. Presented as a conference abstract.

Intervention and comparator(s)

All patients had previous incision and drainage of perianal abscess. Twelve fistulae were injected with Permacol and followed-up within 2 months. Two patients had diagnosed Crohn's disease.

Key outcomes

After 2 months the fistula site was examined to assess tract healing and cessation or continuation of leakage.

Strengths and limitations

There is limited detail in the reporting of methods and results for this study. The study was done in the NHS.

Giordano et al. (2016)

Study size, design and location

Prospective, observational clinical trial in 28 patients with anal fistulae in 10 centres in the UK, Italy and Denmark.

Intervention and comparator(s)

All anal fistulae were treated with Permacol and followed-up at 1, 3, 6 and 12 months.

Key outcomes

During follow-up fistula healing, faecal continence, patient satisfaction and adverse events were recorded. The primary end point was fistula healing rate.

At 6-month follow-up, 15 of 28 (54%) were healed, and the healing rate was maintained at 12 months. No difference in healing was found between intersphincteric and transphincteric fistulae or primary and recurrent fistulae. One adverse event (perianal abscess) occurred that was possibly related to the treatment. 60% of patients were satisfied or very satisfied with the operation.

Strengths and limitations

The study used data from the 30 patients that were initially enrolled in the Maserati 100 trial; 2 patients did not have data at 6-month follow-up. More information will be available when this study is published. This study was sponsored by Medtronic.

Giordano et al. (2015)

Study size, design and location

Conference abstract reporting on the final results of the Maserati 100 prospective, observational clinical trial in 100 patients with intersphincteric or transphincteric anal fistulae, cryptoglandular primary or recurrent, from 10 centres in UK, Italy and Denmark.

Intervention and comparator(s)

All fistulae were treated with Permacol and followed-up at 1, 3, 6 and 12 months.

Key outcomes

During follow-up fistula healing, faecal continence, patient satisfaction and adverse events were recorded. The primary end point was fistula healing rate.

Median operative time was 21 minutes, and median time for patients to return to work was 7 days. At 6-month follow-up, 55 of 97 patients (56.7%) had a healed anal fistula. Fistula healing rate at 12 months was 53.5%. Over 70% of patients reported satisfaction at their final assessment. No serious adverse events were recorded.

Strengths and limitations

This conference abstract reported on the final results of the Maserati 100 trial. More information will be available when this study is published. This study was sponsored by Medtronic.

Zawadzki et al. (2014)

Study size, design and location

Conference abstract detailing a case study of 20 consecutive patients, 15 with cryptoglandular and 5 with Crohn's-related fistulae. Located in Sweden.

Intervention and comparator(s)

Fistulae were drained with loose setons before treatment with Permacol. 3D anal ultrasound diagnostics was done before and after surgery. Patients had antibiotics for 10 days after treatment.

Key outcomes

After 6 months, 4 of 20 (20%) fistulae had healed, as assessed by clinical and anal ultrasonic investigation.

Strengths and limitations

There is limited detail on the methods and results. The results showed a much lower healing rate than that found in other studies. This indicates that there may be a high degree of variance in centre success rates.