Single-port Versus Conventional Laparoscopic Colorectal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SPA Single-port access surgery |
Procedure: Single-port access surgery
Surgery carried out through a single incision laparoscopic approach
|
| Active Comparator: CL Conventional Laparoscopic access |
Procedure: Conventional Laparoscopic Access
Surgery through standard multiport laparoscopic approach
|
Outcome Measures
Primary Outcome Measures
- Operative Time [assessment of electronic records at 30 days from surgery]
Operative Time
Secondary Outcome Measures
- Pain scores [change from baseline at 1,2,3,4 and 5 days from surgery]
Pain scores on visual Analog Scale
- 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
- LoS [assessment at 30 days from surgery]
Length of hospital stay
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital North Tees | Stockton on Tees | United Kingdom | TS19 8PE |
Sponsors and Collaborators
- North Tees and Hartlepool NHS Foundation Trust
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SUR-089