Impact of Seton Use on Clinical, Patient-Reported, and Healthcare Resource Utilization Outcomes in Complex Crohn's Perianal Fistulas: A Systematic Literature Review

Ian White; Chitra Karki; Parnia Geransar; Lilia Leisle; Sophia Junker; Phillip Fleshner

doi:10.1093/ibd/izae186

Impact of Seton Use on Clinical, Patient-Reported, and Healthcare Resource Utilization Outcomes in Complex Crohn's Perianal Fistulas: A Systematic Literature Review

Inflamm Bowel Dis. 2024 Sep 19:izae186. doi: 10.1093/ibd/izae186. Online ahead of print.

Authors

Ian White^{1

2}, Chitra Karki³, Parnia Geransar⁴, Lilia Leisle⁵, Sophia Junker⁵, Phillip Fleshner⁶

Affiliations

¹ Department of Surgery, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel.
² Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
³ Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA.
⁴ Takeda Pharmaceuticals International AG, Zurich, Switzerland.
⁵ Ingress-Health HWM GmbH, an affiliate of Cytel, Inc., Real World & Advanced Analytics, Berlin, Germany.
⁶ Cedars-Sinai Medical Center, Division of Colon and Rectal Surgery, Los Angeles, CA, USA.

PMID: 39298676
DOI: 10.1093/ibd/izae186

Abstract

Background: Optimal treatment strategies for seton use in patients with Crohn's perianal fistulas (CPF) remain elusive. This systematic literature review aimed to summarize clinical, patient-reported, and healthcare resource utilization (HCRU) outcomes associated with seton use for symptomatic relief and treatment of complex CPF.

Methods: Electronic databases (MEDLINE, Embase, EBM Reviews, EconLit) were searched. Titles, abstracts, and relevant full texts were screened by 2 reviewers for inclusion using prespecified PICOS-T criteria. Articles published in English between January 1, 1980 and September 6, 2021 were included; animal/in vitro studies and case reports with <5 patients were excluded. Outcomes of interest included rates of complete response/remission and fistula recurrence in patients receiving seton with/without infliximab or biologics. Data were summarized using descriptive statistics.

Results: Overall, 56 studies were included (full texts: n = 43; congress abstracts: n = 13). CPF and clinical outcome definitions were heterogeneous. Rates (range) of complete response/remission varied widely (seton: 13%-75%; seton + infliximab: 23%-100%; seton + biologics: 23%-59%) as did rates for fistula recurrence (seton: 4%-68%; seton + infliximab: 0%-50%; seton + biologics: 0%-17%). Rates of fistula-related reintervention, new fistula or abscess formation, and abscess recurrence were also varied; more consistency was observed regarding the use of patient-reported outcomes. Few studies reported outcomes from pediatric/adolescent patients or HCRU.

Conclusions: Optimal use of seton in patients with CPF remains unclear. International standardization of definitions for CPF and related clinical outcomes are required to permit data comparability and identify the most effective treatment strategies involving seton use in CPF.

Keywords: Crohn’s disease; perianal fistula; seton.

Plain language summary

A comprehensive systematic literature review was performed to evaluate clinical, patient-reported, and healthcare resource utilization outcomes associated with seton use in the management of patients with complex Crohn’s perianal fistulas.

Grants and funding

Takeda Pharmaceuticals