Anal Fistula Clinical Trial
Official title:
Efficacy and Safety of Treatment of Complex Anal Fistulas Not Associated With Crohn's Disease Using Centrifuged Adipose Tissue Containing Progenitor Cells: a Randomized Controlled Clinical Trial
In the treatment of complex anal fistulas transplant of freshly collected autologous adipose
tissue mechanically fragmented or centrifuged adipose tissue (CAT) might be an alternative to
in vitro expanded autologous or allogeneic adipose-derived stem cells, showing remarkable
efficacy in diverse therapeutic indications.
The aim of our study is to evaluate randomly the efficacy and safety of the use of CAT in the
healing process of complex anal fistulas, except for Crohn's disease (CD) related fistulas.
This monocentric randomized controlled study was designed to test the efficacy and safety of
injection of CAT for treatment of complex fistula-in ano, not associated with CD . The study
was conducted at the Second Surgical Unit of the University Hospital of Ferrara, located in
the North East of Italy. All consecutive patients referred to our clinic with complex anal
fistula were screened. Patients were enrolled from May 2016 through May 2019.
Eligible patients were randomly assigned, according to a 1:1 scheme, to receive treatment
with or without CAT (120 patients totally). The primary endpoint was defined as the
proportion of patients whose fistula was completely healed within 4 weeks after surgery.
Fistula healing was defined as the absence of any anal symptom, with no discharge from the
fistula and a closed external opening confirmed on clinical evaluation. Fistula healing was
eventually confirmed by a pelvic MRI at 3 months after surgery.Moreover, we analyzed
postoperative pain measured by Visual Analogue Scale for 2 weeks after surgery to evaluate
whether CAT injection could modulate pain, and recurrence at 6 months to evaluate the
long-term efficacy of CAT injection.
Faecal continence was assessed before surgery and at 6-months follow-up visit using the
Cleveland Clinical Florida Fecal Incontinence (CCF-FI) questionnaire. Adipose tissue from
periombelical or lateral abdomen was harvested from these patients by liposuction to prepare
CAT using Coleman's technique.Complex anal fistulas were treated by conventional surgery.
Once the seton (present in the most of patients) was removed, after identification of
internal opening, necrotic and inflamed tissues were excised using a "cone-like" fistulectomy
or debrided with a wire brush to remove granulation tissue by the help of fistuloscope (VAAFT
modified, without destroying the fistulous track with monopolar electrode). Before CAT
injection, the internal opening was treated in two ways: by simply closing it using 2-0
Vicryl stitches on the muscular and mucosal layers or by performing a mucosal advancement
rectal flap.
CAT was injected into the submucosal layer surrounding the internal opening, and around the
fistula tract wall (in case of VAAFT modified) or inside the perianal wound after
fistulectomy, using a 1-mL syringe equipped with a 22-gauge and 30-mm length needle, dividing
injections at all quadrants of fistula wall, or distributing the CAT inside the perianal
wound, at different levels by using multiple passes from the internal to the external
openings until there was firm swelling surrounded the fistula tract. The external opening was
approximated loosely with a suture to allow drainage of the fistula, but not extrusion of the
centrifuged adipose tissue. The amount of product injected may vary depending on the total
amount harvested but it should be not less than 10 ml. Patients were assessed for fistula
healing, pain (VAS) and AEs at 1 week, 2 weeks, 4 weeks, 8 weeks, three months, and 6 months
after treatment. Assessment consisted of clinical examination and AEs and VAS registration.
Pelvic MRI was performed at 3 months after surgery. The Cleveland Clinical Florida Fecal
Incontinence (CCF-FI) questionnaire was administered before surgery and at 6-months follow-up
visit. At the final visit patients were also asked about their overall satisfaction with the
procedure, with ratings from very satisfied to very dissatisfied.
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