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. 2025 Jan 11;19(1):jjae199.
doi: 10.1093/ecco-jcc/jjae199.

A new protocolized treatment strategy optimizing medical and surgical care leads to improved healing of Crohn's perianal fistulas

Michael De Gregorio  1   2 , Leon S Winata  3 , Imogen Hartley  1   2 , Corina C Behrenbruch  2   4 , Susan J Connor  5   6 , Basil D'Souza  2   7 , Chamara Basnayake  1   2 , Glen R Guerra  4   8 , Michael J Johnston  4 , Michael A Kamm  1   2 , James O Keck  4 , Mark Lust  1 , Ola Niewiadomski  1 , Eugene J S Ong  4 , Julien D Schulberg  1   2 , Ashish Srinivasan  2   9   10 , Tom Sutherland  2   3 , Rodney J Woods  4 , Emily K Wright  1   2 , William R Connell  1 , Alexander J Thompson  1   2 , Nik S Ding  1   2
Affiliations

A new protocolized treatment strategy optimizing medical and surgical care leads to improved healing of Crohn's perianal fistulas

Michael De Gregorio et al. J Crohns Colitis. .

Abstract

Background and aims: Crohn's perianal fistula healing rates remain low. We evaluated the efficacy of a protocolized multidisciplinary treatment strategy optimizing care in adults with Crohn's perianal fistulas.

Methods: A new treatment strategy was established at a single tertiary center. The strategy comprised 3 dynamic stages of care directed toward achieving and maintaining fistula healing. Stage A, active disease, focused on early commencement and proactive escalation of biologic therapies and structured surgical reviews ensuring adequate fistula drainage and conditioning. Stage B, optimized disease with a seton in situ, focused on consideration for seton removal and appropriateness of definitive surgical closure and/or ablative techniques. Stage C, healed disease, focused on proactive care maintenance. Sixty patients were sequentially enrolled and prospectively followed for ≥12 months. Endpoints included clinical healing and radiologic remission in those with clinically active fistulas, and relapse in those with healed fistulas.

Results: At baseline, 52% (n = 31) and 48% (n = 29) had clinically active and healed fistulas, respectively. For patients with clinically active fistulas, 71% achieved clinical healing after 22 months, with estimated healing rates of 39% and 84% at 1 and 2 years, respectively. Radiologic remission was achieved in 25%, significantly higher than baseline inclusion rates of 6%. For patients with healed fistulas, 7% experienced clinical relapse after 23 months, with no significant change in radiologic remission, 80% versus 86% at baseline.

Conclusions: A protocolized treatment strategy proactively optimizing care resulted in high rates of clinical healing and improved radiologic remission of Crohn's perianal fistulas. Controlled-matched studies are needed.

Keywords: Crohn’s disease; perianal fistulas; treatment optimization.

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Conflict of interest statement

M.D.: served as a speaker for Dr Falk Pharma and Pfizer, received research support, educational support, and/or sponsorship from AbbVie, Celltrion, Dr Falk Pharma, Eli-Lilly, Janssen, and St Vincent’s Hospital Melbourne, and is a recipient of an Australian Commonwealth Government and University of Melbourne scholarship. S.J.C.: received honoraria for Advisory Board participation, speaker fees, educational support, and/or research support from Abbvie, Amgen, BMS, Celltrion, Chiesi, Dr Falk Pharma, Eli-Lilly, Ferring, GSK, Janssen, MSD, Organon, Pfizer, Sandoz, Takeda, Agency for Clinical Innovation, Medical Research Future Fund, South Western Sydney Local Health District, Sydney Partnership for Health, Research and Enterprise (SPHERE), and The Leona M and Harry B Helmsley Charitable Trust. C.B.: served as a speaker for Ferring. J.D.S.: served as a speaker for Dr Falk Pharma and received advisory fees from Abbvie. A.S.: served as a speaker for Arrotex Pharmaceuticals and Dr Falk Pharma and received advisory fees from Abbvie, Amgen, Arrotex Pharmaceuticals, and Pfizer. E.K.W.: served as a speaker and received consulting fees from Abbvie, BMS, Celltrion, Dr Falk Pharma, Janssen, and Pfizer, and received research support from Abbvie, Ferring, and Janssen. N.S.D.: served as a speaker for Abbvie, Dr Falk Pharma, Janssen, Pfizer, and Takeda. All remaining authors had nothing to disclose.

Figures

Figure 1.
Figure 1.
Schematic diagram of the new protocolized treatment strategy centralized around 3 stages of care. Abbreviations: CRS, colorectal surgeon; Gastro, gastroenterologist. *Tract curettage with removal of granulation tissue and manipulation of setons. **Optimize combined immunosuppressant therapy, particularly in the setting of anti-TNF agents, and consider antibiotics during biologic commencement. #Review clinical and radiologic disease characteristics at multidisciplinary meeting involving colorectal surgeons, gastroenterologists, and radiologists, to achieve consensus recommendation regarding definitive surgery.
Figure 2.
Figure 2.
Proportion of patients achieving (A) clinical healing and (B) radiologic remission post implementation of the new protocolized treatment strategy compared to baseline inclusion rates pre-implementation, based on patients’ baseline clinical disease activity.
Figure 3.
Figure 3.
Time to (A) clinical healing (n = 31) and (B) clinical relapse (n = 29) for patients with clinically active and healed fistulas at baseline, respectively. Estimates calculated using the Kaplan–Meier survival method.
See this image and copyright information in PMC

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