Feasibility and pilot work

The Pre-Bra Feasibility Study: A mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant based breast reconstruction.

Best-BRA Study: Is subpectoral or pre-pectoral implant placement Best in immediate BReAst reconstruction?

The Bluebelle Study: a feasibility study of three wound dressing strategies in elective and unplanned surgery.

MALIT: feasibility work to inform a main RCT in mallet injury.

HAND-1: A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers.

ROMIO: The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial.

Feasibility and pilot studies are a key focus in the centre. Work undertaken before a main trial provides a crucial opportunity to explore and address uncertainties around conducting a future main trial. Feasibility and pilot studies are particularly important in surgery, where trials face complex and unique challenges. Such challenges include standardising the surgical procedure, blinding patients and surgeons, agreeing and defining meaningful outcomes and surgical culture.

Theme leads:

Jane Blazeby

Kerry Avery

Completed pilot and feasibility studies:

We have worked with a wide range of collaborators to design and deliver several pilot and feasibility studies across many surgical specialties, including oesophageal cancer surgery, lung cancer surgery and surgical site infection. Click on the links to the side to read more about some of these successful studies.

Methodological work to optimise pilot and feasibility work

We have led methodological work to explore and overcome challenges with designing pilot and feasibility work, including both external (stand-alone) pilot studies and randomised controlled trials with an internal pilot phase. We have also examined the current use of pilot and feasibility studies in surgery to identify areas for future improvement.

 

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