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
  Purpose

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 Intervention Phase
Colorectal Cancer
Inflammatory Bowel Disease
Benign Colorectal Neoplasm
Diverticular Disease
Procedure: Single-port access surgery
Procedure: Conventional Laparoscopic Access
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by North Tees and Hartlepool NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626963

Contacts
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

Locations
United Kingdom
University Hospital North Tees Not yet recruiting
Stockton on Tees, United Kingdom, TS19 8PE
Contact: David W Borowski, MD FRCSEd    0044 6142 624078    david.borowski@nth.nhs.uk   
Contact: Talvinder S Gill, MS FRCS    0044 1642 617617 ext 3136    talvinder.gill@nth.nhs.uk   
Sponsors and Collaborators
North Tees and Hartlepool NHS Foundation Trust
  More Information

No publications provided

Responsible Party: David W Borowski, Consultant General and Colorectal Surgeon, North Tees and Hartlepool NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01626963     History of Changes
Other Study ID Numbers: SUR-089
Study First Received: June 18, 2012
Last Updated: June 22, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by North Tees and Hartlepool NHS Foundation Trust:
single-port access
laparoscopic surgery
surgical trauma

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Diverticulum
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Gastroenteritis
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014