The patient and clinician perspective on ‘early’ bowel resection for terminal ileal Crohn's disease (EBRIC): protocol for a multicentre mixed-methods study

IF 2.9 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Colorectal Disease Pub Date : 2025-03-02 DOI:10.1111/codi.70042

Nilofer Husnoo, Lynda Wyld, Alan J. Lobo, Jenna L. Morgan, Deborah Hawkins, Louise Hunt, Nyantara Wickramasekera, Laura Marshall, Steven R. Brown

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Abstract

Aim

Emerging evidence supports the consideration of surgery earlier in the treatment pathway for isolated luminal terminal ileal (TI) Crohn's disease (CD), as an alternative to medical therapy. Surgery is still considered late in the treatment pathway; recruiting participants into trials comparing medical therapy and surgery is difficult. This will be the first study to explore patients' and clinicians' views on bowel resection as an alternative to medical therapy for surgery-naïve luminal TI CD. An understanding of the facilitators and barriers to this approach will provide insight into the gap between the evidence base and practice; these should be considered when designing future trials.

Methods

A multicentre mixed-methods study (NCT06116604) will be conducted. This will include semi-structured interviews with 25–35 patients with TI CD exploring their views of treatment options, a survey of patients who have undergone a bowel resection for TI CD measuring their decision-regret relating to the timing of their first resection (n = 271), and discrete choice experiments with healthcare professionals treating inflammatory bowel disease (surgeons, nurses and gastroenterologists) and with patients with TI CD (n = 100–300 for each participant group) to understand the importance given to different factors when making treatment choices. Patients will be recruited from 10 English and Welsh hospitals and healthcare professionals will be recruited from across the UK.

Ethics and dissemination

This study has been approved by the London—Brent NHS Research Ethics Committee (reference 23/PR/0568). Dissemination will be through international and national colorectal and gastroenterology meetings and through the study patient panel.

Abstract Image

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目的新的证据支持在治疗孤立回肠管腔末端克罗恩病（CD）的过程中尽早考虑手术治疗，以替代药物治疗。在治疗路径中，手术仍被认为是晚期治疗方法；在比较药物治疗和手术治疗的试验中招募参与者非常困难。这将是第一项探讨患者和临床医生对肠道切除术的看法的研究，肠道切除术可替代药物治疗，用于治疗未经手术治疗的管腔型 TI CD。了解这种方法的促进因素和障碍将有助于深入了解证据基础与实践之间的差距；在设计未来试验时应考虑到这些因素。方法将开展一项多中心混合方法研究（NCT06116604）。这将包括对 25-35 名 TI CD 患者进行半结构化访谈，探讨他们对治疗方案的看法；对因 TI CD 而接受过肠道切除术的患者进行调查，衡量他们对首次切除时机的决策后悔程度（n = 271）；对治疗炎症性肠病的医护人员（外科医生、护士和胃肠病学家）和 TI CD 患者进行离散选择实验（每组参与者的人数为 100-300 人），以了解他们在做出治疗选择时对不同因素的重视程度。患者将从英国和威尔士的 10 家医院招募，医护人员将从英国各地招募。伦理和传播本研究已获得伦敦-布伦特国家医疗服务系统研究伦理委员会的批准（编号 23/PR/0568）。将通过国际和国内结直肠和胃肠病学会议以及研究患者小组进行宣传。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Colorectal Disease 医学-胃肠肝病学

CiteScore

6.10

自引率

11.80%

发文量

406

审稿时长

1.5 months

期刊介绍： Diseases of the colon and rectum are common and offer a number of exciting challenges. Clinical, diagnostic and basic science research is expanding rapidly. There is increasing demand from purchasers of health care and patients for clinicians to keep abreast of the latest research and developments, and to translate these into routine practice. Technological advances in diagnosis, surgical technique, new pharmaceuticals, molecular genetics and other basic sciences have transformed many aspects of how these diseases are managed. Such progress will accelerate. Colorectal Disease offers a real benefit to subscribers and authors. It is first and foremost a vehicle for publishing original research relating to the demanding, rapidly expanding field of colorectal diseases. Essential for surgeons, pathologists, oncologists, gastroenterologists and health professionals caring for patients with a disease of the lower GI tract, Colorectal Disease furthers education and inter-professional development by including regular review articles and discussions of current controversies. Note that the journal does not usually accept paediatric surgical papers.