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
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.
Summary of results
In conclusion, SPOTLITE was a global, prospective, observational study that assessed clinical outcomes of surgical interventions in patients with CPF-CD, CD-RVF, and CCF. Within this study population, the proportion of clinical remission of fistula at 3 months was similar across cohorts although it was the highest in the CD-RVF cohort and lowest in the CCF cohort (39.5% in CPFCD, 42.9% in CD-RVF, and 29.4% in CCF). Across all 3 cohorts, approximately half of patients within each cohort reported clinical remission at 12 months (56.9% in CPF-CD, 50.0% in CDRVF, and 47.2% in CCF).
Findings from this study will add to the knowledge base of real-world evidence to better characterize treatment approaches employed in patients with CPF-CD, CD-RVF, and CCF and clinical remission of fistula based on these approachesREC name
London - Bromley Research Ethics Committee
REC reference
21/PR/1154
Date of REC Opinion
23 Dec 2021
REC opinion
Further Information Favourable Opinion