{
  "abstract": "Introduction Management of cryptoglandular anal fistula is characterised by wide variation in diagnostic strategies, surgical techniques and outcome reporting, limiting comparison between studies and hindering evidence-based guideline development. This study aims to implement a standardised core outcome measurement set within a large international observational framework and to evaluate the feasibility of a scalable digitally supported model for global collaborative surgical research.Methods and analysis Cryptoglandular anal fistula treatment is a prospective, international, multicentre observational study comprising two components: a short-term audit capturing clinician-reported outcomes at 3 months and a long-term cohort capturing clinician- and patient-reported outcomes over twelve months. Adults undergoing surgery for primary or recurrent cryptoglandular anal fistula are eligible, excluding non-cryptoglandular aetiologies. Data are collected using secure electronic case report forms and digitally administered patient-reported outcome measures, with paper alternatives available where required. Outcomes are defined according to the Anal Fistula Core Outcome Measurement Set and include clinical and radiological healing, recurrence, complications, reintervention, development of additional fistulas, symptoms, psychological impact of treatment, continence, quality of life and additionally work productivity. The study was designed around a predefined nine-step framework, including multidisciplinary coordination, central ethical approval to support local submissions, artificial intelligence-assisted translation of study materials with native review and implementation of secure digital data capture systems. Based on previous European Society of Coloproctology studies and expected centre volumes, the audit arm aims to include approximately 1000 patients and the cohort arm 500 to 750 patients.Ethics and dissemination Central ethical approval has been obtained from the Medical Ethics Review Committee of the Maastricht University Medical Centre+ under METC 2024-0374 (audit arm) and METC 2024-0361 (cohort arm) with local approvals or waivers secured in participating countries according to national regulations. Written informed consent is obtained for cohort participation. Results will be disseminated through peer-reviewed publications and international conferences, with the aim of informing future guideline development and supporting patient-centred care in cryptoglandular anal fistula management.",
  "authors": [
    {
      "affiliations": [
        "Department of Surgery, Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands",
        "Institute NUTRIM for Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands"
      ],
      "name": "Nedim Tabakovic"
    },
    {
      "affiliations": [
        "Department of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health Research Institute (CAPHRI), Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands"
      ],
      "name": "Merel Kimman"
    },
    {
      "affiliations": [
        "Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK"
      ],
      "name": "James Keatley"
    },
    {
      "affiliations": [
        "Department of Surgery, Open Source Research Organisation, Aalborg, Denmark"
      ],
      "name": "Alaa El-Hussuna"
    },
    {
      "affiliations": [
        "Robin Phillips Fistula Research Unit, St Mark’s Hospital and Academic Institute, London, UK"
      ],
      "name": "Phil Tozer"
    },
    {
      "affiliations": [
        "Department of Surgery, Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands"
      ],
      "name": "David D E Zimmerman"
    },
    {
      "affiliations": [
        "Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK"
      ],
      "name": "Laura Magill"
    },
    {
      "affiliations": [
        "Department of Surgery and Colorectal Surgery, Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands"
      ],
      "name": "Litza Mitalas"
    },
    {
      "affiliations": [
        "Department of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health Research Institute (CAPHRI), Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands"
      ],
      "name": "Sander van Kuijk"
    },
    {
      "affiliations": [
        "Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK"
      ],
      "name": "Tom Pinkney"
    },
    {
      "affiliations": [
        "Institute NUTRIM for Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands",
        "Department of Surgery and Colorectal Surgery, Maastricht Universitair Medisch Centrum+, Maastricht, the Netherlands",
        "GROW Research Institute for Oncology and Reproduction, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands"
      ],
      "name": "Stephanie Breukink"
    }
  ],
  "title": "Evaluating the feasibility of a scalable, digitally supported model for global collaborative surgical research: protocol for a prospective, international, multicentre observational study in cryptoglandular anal fistula treatment (CRAFT)",
  "uid": "daadfc78-7966-5ac8-948d-7e666623f159"
}