Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPA | Experimental | Single-port access surgery |
|
| CL | Active Comparator | Conventional Laparoscopic access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port access surgery | Procedure | Surgery carried out through a single incision laparoscopic approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Operative Time | assessment of electronic records at 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores on visual Analog Scale | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David W Borowski, MD FRCSEd | Contact | 0044 1642 624078 | david.borowski@nth.nhs.uk | |
| Talvinder S Gill, MS FRCS | Contact | 0044 1642 617617 | 3136 | talvinder.gill@nth.nhs.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital North Tees | Recruiting | Stockton-on-Tees | TS19 8PE | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D000076385 | Diverticular Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Laparoscopic Access | Procedure | Surgery through standard multiport laparoscopic approach |
|
| assessment at 30 days post-op |
| Quality of Life indicators | Quality of Life indicators | change from baseline at 2, 4 weeks, & 3 months after surgery |
| Cosmetic appearance | Body-Image scale | 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 | assessment at the end of the study, up to 2 years post-op |
| LoS | Length of hospital stay | assessment at 30 days from surgery |
| IL-6 | Immune response to tissue trauma (Interleukin-6) | change from baseline at 2,6,24 and 72 hours from surgery |
| IL-8 | Interleukin-8 | change from baseline at 2,6,24 and 72 hours from surgery |
| WBCC | White Blood Cell Count | change from baseline at 2,6,24 and 72 hours from surgery |
| CRP | C-reactive Protein | change from baseline at 2,6,24 and 72 hours from surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |