Perianal Fistula Clinical Trial
Official title:
Treatment of Perianal Fistulas Through Injection of Autologous and Micro-fragmented Adipose Tissue: a Prospective Multicentre Study
The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.
STUDY BACKGROUND
Perianal fistulas are diseases that, by their nature, do not tend to heal spontaneously and
are very rarely cured with medical treatment. Their healing is usually pursued through
surgery, which often needs to be repeated due to the natural tendency of the fistulas to
recur. A surgical treatment that is currently able to provide a high chance of healing is
fistulotomy which, however, can injure the anal sphincter and may result in degrading scars
and possible fecal incontinence. One possible strategy could be the lipofilling, i.e.,
autologous adipose tissue transplant containing, among the many, pericytes and progenitor
cells, including adult mesenchymal stem cells.
STUDY DESIGN
This is a no profit interventional prospective multicenter study without drugs where 100
patients (10 each participant centre) with a diagnosis of trans-sphincteric anal fistula that
is not suitable to be laid open will be enrolled.
After the enrolment, medical history and clinical data will be collected and pre-operatory
exams will be performed.
METHODS
- Harvesting of the adipose tissue
The lower/lateral abdomen or, eventually, the inner/outer thigh will be chosen as donor site
for adipose tissue harvesting under general or spinal anaesthesia. Before the harvesting, the
donor site will be injected with 100 cc of Klein Solution (500 cc saline, 1 cc epinephrine
1/1000 IU, and 40 cc lidocaine 2%) using a disposable 17 gauge blunt cannula connected to a
60-cc luer-lock syringe. The fat will be then harvested (50-100 cc) using a 13 gauge blunt
cannula connected to a 20-ml VacLok® syringe.
- Processing of the adipose tissue with the Lipogems® device
The harvested fat will be immediately processed in the Lipogems® processing kit (Lipogems
International Spa, Milan, Italy). Lipogems® is a disposable device that mechanically reduces
the size of the adipose tissue clusters while eliminating oily substances and blood residues
with pro-inflammatory properties. The entire process is carried out in one surgical step in
complete immersion in physiological solution minimizing any traumatic action on the cells and
microarchitecture. The processed micro-fragmented fat will be collected in a 60-cc syringe
and positioned to decant the excess of saline solution. At the end, the product will be
transferred in several 5-cc syringes to be re-injected in the patient.
- Surgical procedure and micro-fragmented adipose tissue (Lipogems®) injection
The micro-fragmented autologous adipose tissue will be injected with wheals of no more than
1cc in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula
tract and external orifice.
- Follow-up visits and outcome measures
All patients will be assessed at 7 days, 1, 3, 6 and 12 months after the procedure.
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