Surgical Interventions in Fistulizing Conditions

• Research type

  Research Study

• Full title

  SPOTLITE: Prospective ObservationaL Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

• IRAS ID

  302135

• Contact name

  Ailsa Hart

• Contact email

  ailsa.hart@nhs.net

• Sponsor organisation

  Takeda

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This study aims to fulfill a global evidence gap for real world data collected from the patients post-surgery to treat fistulizing conditions, particularly over the long-term.The study will generate real world evidence globally on standard of care (SOC) related to surgical interventions for treating complex fistulizing conditions, to create a large dataset on SOC practice. The study will follow patients prospectively for 24 months after surgical intervention for the fistulizing condition at enrollment, to capture real world data detailing short-term and long-term outcomes (clinical and patient reported) and impact on quality of life.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  21/PR/1154

• Date of REC Opinion

  23 Dec 2021

• REC opinion

  Further Information Favourable Opinion