Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research

Area of Science:

• Surgical research methodology
• Clinical trial design
• Health services research

Background:

• Randomized controlled trials (RCTs) are essential for surgical evidence but face challenges with cost, complexity, and time.
• Observational registries offer a potential solution for conducting surgical RCTs more efficiently.
• Few registry-based surgical RCTs have been successfully implemented to date.

Purpose of the Study:

• To present a novel approach for conducting surgical registry-based RCTs.
• To demonstrate the feasibility and early results of this methodology.
• To highlight the benefits of registry integration for surgical research.

Main Methods:

• Focus on integrating registries into surgeons' existing workflows.
• Routine collection of patient-reported outcomes during clinic visits.
• Pragmatic trial design with broad inclusion criteria and standard follow-up protocols.

Main Results:

• Completed enrollment in 4 registry-based RCTs since 2017, with 5 ongoing.
• Over 1000 patients enrolled across multicenter trials, achieving high follow-up rates (≥90%).
• Trials demonstrate efficient enrollment timelines (approx. 2 years) and low resource utilization, with no terminations due to resources or futility.

Conclusions:

• Registry-based RCTs enable efficient pragmatic surgical trials.
• Key success factors include thoughtful study design, seamless registry integration, and a research-supportive team culture.
• Registry-based trials represent a promising future for affordable, high-level prospective surgical research.