Assessing minimally invasive surgery for oesophageal cancer
Theme Surgical and orthopaedic innovation
Workstreams Innovative translational research methods Novel surgical and orthopaedic techniques and devices
Status: This project is complete
It is common for surgeons to modify new surgical procedures. Modifications don’t usually happen in a research setting. This makes evaluating new procedures difficult. Some modified procedures become widely used without evidence to support their effectiveness.
At the time we started this study a randomised controlled trial performed in the Netherlands showed a very short-term benefit to totally minimally invasive surgery for oesophageal cancer.
The result of this trial then influenced national practice in that country. However, subsequent data showed the procedure was associated with increased risks for patients. There were also concerns about the technique.
We therefore decided to conduct a small study to consider safety and efficacy of the procedure.
Project aims
The aim of this study was to explore the safety, efficacy and acceptability of a new totally minimally invasive surgery for oesophageal cancer (the oesophagus is the pipe connecting our mouth to our stomach).
We nested our evaluation within a large randomised clinical trial aimed at comparing two standard surgical procedures performed for this type of cancer.
Nesting a small study within a large trial to explore the safety of a procedure is an innovative approach we have been working on. It could be used during future studies of evolving surgical procedures. This is because it provides information relevant to potentially translating a small-scale evaluation of a procedure into a larger study.
What we did
We worked with surgeons in 2 of the 8 centres where the trial was being run.
In the two centres we worked with, the totally minimally invasive procedure was performed only by surgeons able to do it, on participants who were randomly assigned to it (there was a 1 in 3 chance of this occurring).
We monitored:
- How the procedure evolved over time and between patients
- Whether new surgeons took up the technique
- Safety and outcome data
What we found
We found that the evaluated procedure continued to evolve during the study. No new surgeons took up the technique. The procedure was safe.
These findings meant that it was not appropriate to include this new technique in a major large trial.
