Clinical trial NCT01626963: Single-port Versus Conventional Laparoscopic Colorectal Surgery
Official title: Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Inflammatory Bowel Disease
Benign Colorectal Neoplasm
Diverticular Disease
Keywords: single-port access
laparoscopic surgery
surgical trauma
Lead sponsor: North Tees and Hartlepool NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Operative Time
timeFrame: assessment of electronic records at 30 days from surgery
Secondary outcomes:
measure: Pain scores
timeFrame: change from baseline at 1,2,3,4 and 5 days from surgery
measure: Complication / Conversion-to-open-surgery rates
timeFrame: assessment at 30 days post-op
measure: Quality of Life indicators
timeFrame: change from baseline at 2, 4 weeks, & 3 months after surgery
measure: Cosmetic appearance
timeFrame: change from baseline at 2, 4 weeks and three months after surgery
measure: Cost comparison
timeFrame: assessment at the end of the study, up to 2 years post-op
measure: LoS
timeFrame: assessment at 30 days from surgery
measure: IL-6
timeFrame: change from baseline at 2,6,24 and 72 hours from surgery
measure: IL-8
timeFrame: change from baseline at 2,6,24 and 72 hours from surgery
measure: WBCC
timeFrame: change from baseline at 2,6,24 and 72 hours from surgery
measure: CRP
timeFrame: change from baseline at 2,6,24 and 72 hours from surgery
Other outcomes:
Locations:
city: Stockton on Tees
country: United Kingdom
facility: University Hospital North Tees
Study officials:
References: