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Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility

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Abstract

Background

The aim of the present study was to evaluate the safety and efficacy of autologous, micro-fragmented and minimally manipulated adipose tissue injection associated closure of the internal opening in promoting healing of complex anal fistula.

Methods

A pilot study was conducted on patients referred to our center with anal fistula, from April 2015–December 2016. Inclusion criteria were age over 16 years old and a diagnosis of complex anal fistula according to the American Gastroenterological Association classification The patients were divided into 2 groups; the “first time group” (Group I) in which micro-fragmented adipose tissue injection with closure of the internal opening was the first sphincter-saving procedure, and the “recurrent group” (Group II) consisting of patients who had failed prior sphincter-saving procedures. The procedure was carried out 4–6 weeks after seton placement. Follow-up visits were scheduled at 7 days, and 1, 3, 6 and 12 months after surgery. Fistula healing was defined as the closure of the internal and external openings without any discharge.

Results

Out of 47 patients with complex transsphincteric anal fistula, 19 met the inclusion criteria and were selected to undergo the procedure. Twelve of these patients (Group I) had micro-fragmented adipose tissue injection as first-line treatment, and 7 (Group II) had failed previous sphincter-saving procedures. The mean operative time was 55 ± 6 min (range 50–70 min). The mean postoperative pain score measured with the visual analog pain scale was 2 ± 1.4 (range 0–4). No intraoperative difficulties related to the use of the kit were recorded. There were no cases of postoperative fever or abdominal sepsis related to the procedure and no post-treatment perianal bleeding or impaired anal continence. Only 3 cases of minor abdominal wall hematoma that did not require any treatment and 1 case of perianal abscess were observed. Patients were evaluated for a mean follow-up time of 9 ± 3.1 months (range 3–12 months). The overall healing rate was 73.7, 83.3% for Group I and 57.1% for Group II.

Conclusions

The injection of autologous, micro-fragmented and minimally manipulated adipose tissue associated with closure of the internal opening is a safe, feasible and reproducible procedure and may enhance complex anal fistula healing.

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Authors and Affiliations

  1. Proctological and Perineal Surgery Unit, Cisanello University Hospital, Via Paradisa 2, Pisa, Italy

    G. Naldini, A. Sturiale, B. Fabiani, I. Giani & C. Menconi

Authors
  1. G. Naldini
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  2. A. Sturiale
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  3. B. Fabiani
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  4. I. Giani
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  5. C. Menconi
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Contributions

GN, AS and IG contribute to the conception and of the study and to the drawing up of the manuscript; AS, IG and BF contribute to the data acquisition, analysis and interpretation; AS, CM and GN contribute to the critical revision of the manuscript and to the approval of the version to be published.

Corresponding author

Correspondence to A. Sturiale.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Naldini, G., Sturiale, A., Fabiani, B. et al. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol 22, 107–113 (2018). https://doi.org/10.1007/s10151-018-1755-8

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  • DOI: https://doi.org/10.1007/s10151-018-1755-8

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