3D vs 2D laparoscopic rectal surgery: randomised controlled trial
Research type
Research Study
Full title
The role of 3D laparoscopic rectal surgery: multi-centre randomised controlled trial
IRAS ID
195969
Contact name
Nader Francis
Contact email
Sponsor organisation
Yeovil District Hospital NHS Foundation Trust
ISRCTN Number
ISRCTN59485808
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
Bowel cancer remains a common condition. The last part of large bowel, the rectum, requires specialist management. There were 14226 new cases of rectal cancer diagnosed in England and Wales in 2011. The best hope of cure is surgery to remove the rectum. Laparoscopic (keyhole), minimally invasive surgery has become widespread as it results in a quicker recovery with less pain and scars without compromising on the quality of the surgery. Performing keyhole surgery on the rectum is difficult as the pelvis is a tight space with important anatomical structures close by and is located far from the small abdominal incisions made.
Technological developments have resulted in new equipment being available. It is now possible to display three-dimensional (3D) images. This can provide the surgeon with depth of view and replicate the 3D nature of the body. This may enhance the surgeon’s ability and result in quicker and much safer operation. It is possible the 3D picture causes side effects such as headache or eye strain. 3D monitors have not been studied within randomised trials in rectal cancer surgery.
We will investigate 3D laparoscopic technology by comparing with current 2D equipment and how it affects the surgeon and their technical performance of the operation. A minimum of 72 patients in need of rectal cancer surgery, in four NHS trusts, will be invited to join this study. If informed consent is provided, their surgeon is randomly allocated either 2D or 3D technology for that case. No other aspect of the patient’s care is altered in any way. Each operation will be anonymously recorded and analysed to objectively assess the performance. No additional tests, hospital visits or patient contact is required and all treatment decisions (including how the surgeon performs the case remain unchanged) remain with the team caring for the patient.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0118
Date of REC Opinion
24 Feb 2016
REC opinion
Favourable Opinion