Single-port versus conventional laparoscopic colorectal surgery
Research type
Research Study
Full title
Randomised-controlled trial on the immune response to single-port access versus conventional laparoscopic colorectal surgery
IRAS ID
108470
Contact name
David W Borowski
Contact email
Sponsor organisation
North Tees and Hartlepool NHS Foundation Trust
Clinicaltrials.gov Identifier
Research summary
Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it’s short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.
In this study, we aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, we aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
13/YH/0241
Date of REC Opinion
4 Oct 2013
REC opinion
Further Information Favourable Opinion