The “R-3D-2” pilot study.

• Research type

  Research Study

• Full title

  The “R-3D-2” pilot study. (Randomised Controlled Trial On The Impact Of Rehearsal Strategies In Rectal Cancer Surgery Using 3D Models By 2 Methods)

• IRAS ID

  165586

• Contact name

  Marina Yiasemidou

• Contact email

  marinayiasemidou@gmail.com

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Large bowel cancer is the fourth most common cancer in the UK. In 2010 alone, approximately 40000 new cases were diagnosed. More than a third of these cases were cancers of the lower part of the bowel, the rectum. The only definitive treatment for rectal cancer is surgery. However, this type of procedure is technically very demanding and often followed by serious complications.
  Surgeons currently perform rectal cancer surgery, guided by radiological images (e.g. magnetic resonance MR). Even though some surgeons can identify the location and extent of tumour and anatomical structures, most find “translating” 2D cross sectional images into 3D anatomy; challenging. We propose the creation of three dimensional (3D) virtual and plastic models of the inner organs, for individual patients, to assist surgeons prepare better for an operation.

  The aim of our study is to examine how feasible it is to assess the clinical impact of pre-operative preparation using two types of patient individualised models; virtual 3D models and plastic models. The virtual model will be created from routine radiological images through a process called “reconstruction”. The plastic ones will be created through 3D printing the virtual models.

  We will recruit 63 patients for this study and 8 surgeons. The patients will be randomly allocated to three groups: Surgeons operating on group 1 will use patient specific 3D virtual models to re-enact mentally the operation they are due to perform. Surgeons operating on group two will be given patient specific plastic models to perform a rehearsal procedure. Finally, surgeons on group 3 will use routine radiology scans to mentally re-enact the procedure.
  The performance of surgeons operating on all three groups will be assessed using 2 scoring tools and compared between the three groups. Patient complications will also be compared between the three groups.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  15/YH/0134

• Date of REC Opinion

  13 May 2015

• REC opinion

  Further Information Favourable Opinion