UROLE trial
Research type
Research Study
Full title
Urological and sexual function in males following robotic vs laparoscopic rectal surgery: An international, multicentre, randomised control trail.
IRAS ID
211302
Contact name
Amjad Parvaiz
Contact email
Sponsor organisation
Poole Hospital NHS Foundation trust
Duration of Study in the UK
2 years, 3 months, 8 days
Research summary
Urological and sexual dysfunction has been identified as a significant problem for patients following rectal surgery, which significantly affects the quality of life and psychological healing of survivors. Even though laparoscopic (keyhole) rectal surgery has been found to be superior to open surgery in terms of postoperative recovery, cosmetics and blood loss; it’s debatable whether it offers any improvement regarding urological and sexual function. Robotic surgery is a contemporary method of operating on patients requiring rectal surgery and may be a solution that overcomes this problem. Several current studies suggest that urological and sexual function might recover faster in male patients receiving robotic surgery. However, the evidence is limited, with studies lacking randomisation, being retrospective in nature and reporting small numbers of cases.
A prospective, randomised controlled trial focusing on urogenital dysfunction with appropriate case numbers is required to establish whether robotic rectal surgery can reduce urological and sexual dysfunction. We propose such a study whose aim will be to investigate whether robotic rectal surgery leads to improved urogenital functional outcomes or a quicker recovery of urogenital function. This study will involve three centres in the UK and one centre in Portugal. It is proposed that these centres shall recruit a sample population of all male patients requiring elective rectal surgery that shall be consented to take part in this research and will be randomised to receive either robotic or laparoscopic surgery for comparative analysis of urological and sexual dysfunction. Urological and sexual function will be assessed via self-reporting validated questionnaires for assessing urological and sexual function – the IPSS (International Prostatic Symptoms Score) and the IIEF (International Index of Erectile Function). These will be administered prior to randomisation and at three, six and 12 months following surgery. During the same time intervals, baseline urodynamic studies shall be conducted and their results analysed in order to assess urological dysfunction in an alternative way.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0492
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion