eP819 - Treatment of Crohn's Complex Perianal Fistulas With Micro-fragmented Autologous Adipose Tissue Injection: A Multicenter Randomized Controlled Trial (ATTIC)

Monday, June 3, 2024

1:45 PM – 1:50 PM ET, USA

Location: Room 318-320

ePoster Presenter(s)

Silvio Laureti (he/him/his)

Associate Professor of Surgery
University of Bologna - IRCCS Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
University of Bologna - IRCCS Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna, Emilia-Romagna, Italy

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

Author(s)

LS

Luigi Sofo, n/a

Associate Professor of Surgery, Director of Abdominal Surgery Dept
Department of Gastroenterological, Endocrine-Metabolic and Nephro-Urological Sciences, Abdominal Surgery Unit, A. Gemelli University Hospital Foundation and IRCCS, Rome
Rome, Lazio, Italy

Disclosure information not submitted.
Antonino Spinelli, MD, PhD

Disclosure information not submitted.
FC

Francesco Colombo, n/a

Consultant Surgeon- Head of IBD Surgical Unit
Ospedale L. Sacco, Milano
Milano, Lombardia, Italy

Disclosure information not submitted.
GL

Gaetano Luglio, n/a

Associate Professor of General Surgery
University Federico II, AOU Policlinico, Napoli
Napoli, Campania, Italy

Disclosure information not submitted.
SS

Stefano Scaringi, n/a

Consultant Surgeon Hepatobiliary Surgery & digestive system Department
Azienda Ospedaliero Universitaria Careggi, Firenze
Firenze, Toscana, Italy

Disclosure information not submitted.
LG

Lorenzo Gentilini, n/a

Surgeon Alimentary Tract Surgery
University of Bologna - IRCCS Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna, Emilia-Romagna, Italy

Disclosure information not submitted.
FS

Franco Sacchetti, n/a

Assistant Surgeon
Department of Gastroenterological, Endocrine-Metabolic and Nephro-Urological Sciences, Abdominal Surgery Unit, A. Gemelli University Hospital Foundation and IRCCS, Rome
Roma, Lazio, Italy

Disclosure information not submitted.
GC

Giuseppe Clerico, n/a

Surgeon Colon and Rectal Surgery Department
IRCCS Humanitas Research Hospital, Rozzano
Rozzano, Milano, Lombardia, Italy

Disclosure information not submitted.
PD

Piergiorgio Danelli, n/a

Full Professor Of Medicine, Head of Surgical Department
Ospedale L. Sacco, Milano
Milano, Lombardia, Italy

Disclosure information not submitted.
MC

Michele Cricri, n/a

Assistant Surgeon Department of Clinical Medicine and Surgery
University Federico II, AOU Policlinico, Napoli
Napoli, Campania, Italy

Disclosure information not submitted.
FF

Ferdinando Ficari, n/a

Associate professor of surgery
Azienda Ospedaliero Universitaria Careggi, Firenze
Firenze, Toscana, Italy

Disclosure information not submitted.
AC

Alberta Cappelli, n/a

Medical doctor interventional radiology
IRCCS Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna, Emilia-Romagna, Italy

Disclosure information not submitted.
AM

Alessandra Menon, n/a

Clinical study coordinator and statistician
ASST Gaetano Pini-CTO
Milano, Lombardia, Italy

Disclosure information not submitted.
PG

Paolo Gionchetti, n/a

Associate Professor Chief IBD unit, Dept of Medical and Surgical Sciences
University of Bologna - IRCCS Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna, Emilia-Romagna, Italy

Disclosure information not submitted.

Senior Author(s)

GP

Gilberto Poggioli, n/a

Chief of Surgery of Alimentary tract and Emergency Department
IRCCS Azienda Ospedaliera Universitaria S. Orsola Malpighi Bologna
Bologna, Emilia-Romagna, Italy

Disclosure information not submitted.

Image or Table (Do Not add text here):

Purpose/Background: Complex perianal fistulas represent one of the most challenging manifestations of Crohn’s disease. Combined surgical and medical therapy with biologic drugs represents today the first-line treatment option, but its efficacy does not exceed 60% in terms of healing. Recently, new therapeutic approaches, such as autologous microfragmented adipose tissue (M-Fat) injection, have shown promising results. Indeed, a recent non-profit prospective pilot study on 15 patients has demonstrated that the local injection of M-Fat is a safe and promising “rescue therapy” for patients with multiresistant complex fistulizing Crohn’s disease (PCD), with a 66.7% rate of combined remission in such difficult patients. It has to be highlighted that the M-Fat injection is minimally invasive, with less risk of sphincteric damage and can be carried out in day-surgery setting.
The primary aim of this multicentre randomized controlled trial (ATTIC) is to evaluate the efficacy of the infiltration of M-Fat in the healing of perianal complex fistulas not-responding to treatment with biologics.Methods/Interventions: Consecutive patients referring to the investigation Centers for surgical treatment of persistent complex fistulizing PCD refractory to biosurgical approach are assessed for eligibility. After baseline pelvic magnetic resonance imaging, those who are included are randomized to receive a surgical drainage with “cone-like” fistulectomy, followed by a 15 to 20 cc single local administration of M-Fat obtained by a lipoaspiration and processed with an enzyme-free technology, at the internal orifice level and along fistula tract (treatment group) or followed by a 15 cc single-local infiltration of saline solution and sutures placement at the internal orifice (control group).
Clinical follow-up are conducted at 2, 4, 8, 12, and 24 weeks; at 24 weeks after surgery, pelvic magnetic resonance imaging is obtained to assess the combined remission.Results/Outcomes: Up to now, 71 out of 80 patients are enrolled.Conclusion/

Discussion: This multicentre randomized controlled trial aims to demonstrate that the intraoperative injection of M-Fat is safe, effective, and reproducible in healing complex perianal fistulas, while improving the quality of life and significantly reducing the risk of definitive oostomy.