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, the investigators 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, the investigators 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Surgery carried out through a single incision laparoscopic approach
Surgery through standard multiport laparoscopic approach
University Hospital North Tees
Stockton-on-Tees, United Kingdom
RECRUITINGOperative Time
Operative Time
Time frame: assessment of electronic records at 30 days from surgery
Pain scores
Pain scores on visual Analog Scale
Time frame: change from baseline at 1,2,3,4 and 5 days from surgery
Complication / Conversion-to-open-surgery rates
Complication / Conversion-to-open-surgery rates
Time frame: assessment at 30 days post-op
Quality of Life indicators
Quality of Life indicators
Time frame: change from baseline at 2, 4 weeks, & 3 months after surgery
Cosmetic appearance
Body-Image scale
Time frame: change from baseline at 2, 4 weeks and three months after surgery
Cost comparison
Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
Time frame: assessment at the end of the study, up to 2 years post-op
LoS
Length of hospital stay
Time frame: assessment at 30 days from surgery
IL-6
Immune response to tissue trauma (Interleukin-6)
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
IL-8
Interleukin-8
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
WBCC
White Blood Cell Count
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
CRP
C-reactive Protein
Time frame: change from baseline at 2,6,24 and 72 hours from surgery
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