Benign Colorectal Neoplasm, Colorectal Cancer, Diverticular Disease, Inflammatory Bowel Disease
Conditions
Keywords
single-port access, laparoscopic surgery, surgical trauma
Brief 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, 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.
Interventions
PROCEDURESingle-port access surgery
Surgery carried out through a single incision laparoscopic approach
PROCEDUREConventional Laparoscopic Access
Surgery through standard multiport laparoscopic approach
Sponsors
North Tees and Hartlepool NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* large bowel disorder requiring surgical resection * body habitus suitable for single-port access surgery
Exclusion criteria
* patients not capable of informed consent and/or quality of life assessment * planned open procedure for surgical reason * multiple previous abdominal operations * body-mass index \> 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | assessment of electronic records at 30 days from surgery | Operative Time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication / Conversion-to-open-surgery rates | assessment at 30 days post-op | Complication / Conversion-to-open-surgery rates |
| Quality of Life indicators | change from baseline at 2, 4 weeks, & 3 months after surgery | Quality of Life indicators |
| Cosmetic appearance | change from baseline at 2, 4 weeks and three months after surgery | Body-Image scale |
| Cost comparison | assessment at the end of the study, up to 2 years post-op | Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay |
| Pain scores | change from baseline at 1,2,3,4 and 5 days from surgery | Pain scores on visual Analog Scale |
| IL-6 | change from baseline at 2,6,24 and 72 hours from surgery | Immune response to tissue trauma (Interleukin-6) |
| IL-8 | change from baseline at 2,6,24 and 72 hours from surgery | Interleukin-8 |
| WBCC | change from baseline at 2,6,24 and 72 hours from surgery | White Blood Cell Count |
| CRP | change from baseline at 2,6,24 and 72 hours from surgery | C-reactive Protein |
| LoS | assessment at 30 days from surgery | Length of hospital stay |
Countries
United Kingdom
Contacts
Primary ContactDavid W Borowski, MD FRCSEd
Backup ContactTalvinder S Gill, MS FRCS
Outcome results
None listed