IDEAL Stage 2a is Development.
What is the primary goal of this stage?
The goal of the development stage is to refine the technique by extending it to more patients (usually around 30, but this number will vary widely depending on the nature of the procedure).
What are the secondary goals of this stage?
Unlike in stage 1 where ethical approval is not always required since the procedure is new, stage 2a studies (and beyond) should include ethical approval. As such, outcomes should reflect safety and success in doing the procedure. Negative results should continue to be reported.
How should procedures in the Development stage be reported?
Reporting should be in the form of prospective development studies. Cases should be reported consecutively, pointing out where technique or selection criteria change. Studies should include the following:
- Selection criteria
- Eligible patients
- Description of the procedure
- Timing of the procedure
- Outcomes (using standard definitions)
- Complications (using standard definitions)
What are some examples of procedures in this stage?
- Natural orifice translumenal endoscopic surgery (NOTES) for cholecystectomy
- NOTES for appendectomy