Single-port Versus Conventional Laparoscopic Colorectal Surgery

Colorectal Cancer Clinical Trial

Official title:

Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01626963
• Other study ID #: SUR-089
• 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

Related Conditions & MeSH terms

• Benign Colorectal Neoplasm
• Colorectal Cancer
• Colorectal Neoplasms
• Diverticular Disease
• Diverticulum
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

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