# Investigating the presence of surgical learning in the Timing of Primary Surgery for cleft palate randomised trial

## TL;DR

This paper examines whether surgeons improved their skills during a trial comparing cleft palate repair at different ages, which could affect the trial's results.

## Contribution

The study introduces a statistical approach to detect surgical learning effects in a randomized trial of cleft palate repair.

## Key findings

- Surgeons without prior experience showed reduced operation times over time, while those with experience had stable times.
- Fistula rates remained consistent regardless of surgeons' prior experience with the surgical technique.
- Pre-trial experience with age-specific surgery did not influence operation time or fistula rates.

## Abstract

When conducting a randomised controlled trial in surgery, it is important to consider surgical learning, where surgeons’ familiarity with one, or both, of the interventions increases during the trial. If present, learning may compromise trial validity. We demonstrate a statistical investigation into surgical learning within a trial of cleft palate repair.

The Timing of Primary Surgery compared primary surgery, using the Sommerlad technique, for cleft palate repair delivered at 6 or 12 months of age. Participating surgeons had varying levels of experience with the intervention and in repair across the age groups. Trial design aimed to reduce the surgical learning via pre-trial surgical technique training and balancing the randomisation process by surgeon. We explore residual learning effects by applying visual methods and statistical models to a surgical outcome (fistula formation) and a process indicator (operation time).

Notably, 26 surgeons operated on 521 infants. As the trial progressed, operation time reduced for surgeons with no pre-trial Sommerlad experience (n = 2), before plateauing at 30 operations, whereas it remained stable for those with prior experience. Fistula rates remained stable regardless of technique experience. Pre-trial age for primary surgery experience had no impact on either measures.

Managing learning effects through design was not fully achieved but balanced between trial arms, and residual effects were minimal. This investigation explores the presence of learning, within a randomised controlled trial that may be valuable for future trials. We recommend such investigations are undertaken to aid trial interpretation and generalisability, and determine success of trial design measures.