Single-port Versus Conventional Laparoscopic Colorectal Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by North Tees and Hartlepool NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
David W Borowski, North Tees and Hartlepool NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01626963
First received: June 18, 2012
Last updated: June 22, 2012
Last verified: June 2012

June 18, 2012
June 22, 2012
October 2012
December 2014   (final data collection date for primary outcome measure)
  • IL-6 [ Time Frame: change from baseline at 2,6,24 and 72 hours from surgery ] [ Designated as safety issue: No ]
    Immune response to tissue trauma (Interleukin-6)
  • IL-8 [ Time Frame: change from baseline at 2,6,24 and 72 hours from surgery ] [ Designated as safety issue: No ]
    Interleukin-8
  • CRP [ Time Frame: change from baseline at 2,6,24 and 72 hours from surgery ] [ Designated as safety issue: No ]
    C-reactive Protein
  • WBC [ Time Frame: change from baseline at 2,6,24 and 72 hours from surgery ] [ Designated as safety issue: No ]
    White Blood Cell Count
Same as current
Complete list of historical versions of study NCT01626963 on ClinicalTrials.gov Archive Site
  • Pain scores [ Time Frame: change from baseline at 1,2,3,4 and 5 days from surgery ] [ Designated as safety issue: No ]
    Pain scores on visual Analog Scale
  • Operative Time [ Time Frame: assessment of electronic records at 30 days from surgery ] [ Designated as safety issue: No ]
    Operative Time
  • Complication / Conversion-to-open-surgery rates [ Time Frame: assessment at 30 days post-op ] [ Designated as safety issue: Yes ]
    Complication / Conversion-to-open-surgery rates
  • Quality of Life indicators [ Time Frame: change from baseline at 2, 4 weeks, & 3 months after surgery ] [ Designated as safety issue: No ]
    Quality of Life indicators
  • Cosmetic appearance [ Time Frame: change from baseline at 2, 4 weeks and three months after surgery ] [ Designated as safety issue: No ]
    Body-Image scale
  • Cost comparison [ Time Frame: assessment at the end of the study, up to 2 years post-op ] [ Designated as safety issue: No ]
    Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
  • LoS [ Time Frame: assessment at 30 days from surgery ] [ Designated as safety issue: No ]
    Length of hospital stay
Same as current
Not Provided
Not Provided
 
Single-port Versus Conventional Laparoscopic Colorectal Surgery
Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery

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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Colorectal Cancer
  • Inflammatory Bowel Disease
  • Benign Colorectal Neoplasm
  • Diverticular Disease
  • Procedure: Single-port access surgery
    Surgery carried out through a single incision laparoscopic approach
  • Procedure: Conventional Laparoscopic Access
    Surgery through standard multiport laparoscopic approach
  • Experimental: SPA
    Single-port access surgery
    Intervention: Procedure: Single-port access surgery
  • Active Comparator: CL
    Conventional Laparoscopic access
    Intervention: Procedure: Conventional Laparoscopic Access
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: David W Borowski, MD FRCSEd 0044 1642 624078 david.borowski@nth.nhs.uk
Contact: Talvinder S Gill, MS FRCS 0044 1642 617617 ext 3136 talvinder.gill@nth.nhs.uk
United Kingdom
 
NCT01626963
SUR-089
Yes
David W Borowski, North Tees and Hartlepool NHS Foundation Trust
North Tees and Hartlepool NHS Foundation Trust
Not Provided
Not Provided
North Tees and Hartlepool NHS Foundation Trust
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP