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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01626963
Other study ID # SUR-089
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received June 18, 2012
Last updated March 22, 2016
Start date January 2014
Est. completion date December 2016

Study information

Verified date March 2016
Source North Tees and Hartlepool NHS Foundation Trust
Contact David W Borowski, MD FRCSEd
Phone 0044 1642 624078
Email david.borowski@nth.nhs.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Procedure:
Single-port access surgery
Surgery carried out through a single incision laparoscopic approach
Conventional Laparoscopic Access
Surgery through standard multiport laparoscopic approach

Locations

Country Name City State
United Kingdom University Hospital North Tees Stockton on Tees

Sponsors (1)

Lead Sponsor Collaborator
North Tees and Hartlepool NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative Time Operative Time assessment of electronic records at 30 days from surgery No
Secondary Pain scores Pain scores on visual Analog Scale change from baseline at 1,2,3,4 and 5 days from surgery No
Secondary Complication / Conversion-to-open-surgery rates Complication / Conversion-to-open-surgery rates assessment at 30 days post-op Yes
Secondary Quality of Life indicators Quality of Life indicators change from baseline at 2, 4 weeks, & 3 months after surgery No
Secondary Cosmetic appearance Body-Image scale change from baseline at 2, 4 weeks and three months after surgery No
Secondary 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 No
Secondary LoS Length of hospital stay assessment at 30 days from surgery No
Secondary IL-6 Immune response to tissue trauma (Interleukin-6) change from baseline at 2,6,24 and 72 hours from surgery No
Secondary IL-8 Interleukin-8 change from baseline at 2,6,24 and 72 hours from surgery No
Secondary WBCC White Blood Cell Count change from baseline at 2,6,24 and 72 hours from surgery No
Secondary CRP C-reactive Protein change from baseline at 2,6,24 and 72 hours from surgery No
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