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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Inflammatory Bowel Disease; Diverticular Disease; Benign Colorectal Neoplasm
• Intervention / Treatment: Procedure: Single-port access surgery; Procedure: Conventional Laparoscopic Access

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: David W Borowski, MD FRCSEd; Phone Number: 0044 1642 624078; Email: david.borowski@nth.nhs.uk
• Study Contact Backup: Name: Talvinder S Gill, MS FRCS; Phone Number: 3136 0044 1642 617617; Email: talvinder.gill@nth.nhs.uk

Study Locations

• United Kingdom
  • Stockton on Tees, United Kingdom, TS19 8PE
    • Recruiting
    • University Hospital North Tees
    • Contact: Talvinder S Gill, MS FRCS; Phone Number: 3136 0044 1642 617617; Email: talvinder.gill@nth.nhs.uk
    • Contact: David W Borowski, MD FRCSEd; Phone Number: 0044 6142 624078; Email: david.borowski@nth.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Operative Time	assessment of electronic records at 30 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores on visual Analog Scale	change from baseline at 1,2,3,4 and 5 days from surgery
Complication / Conversion-to-open-surgery rates	Complication / Conversion-to-open-surgery rates	assessment at 30 days post-op
Quality of Life indicators	Quality of Life indicators	change from baseline at 2, 4 weeks, & 3 months after surgery
Cosmetic appearance	Body-Image scale	change from baseline at 2, 4 weeks and three months after surgery
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
LoS	Length of hospital stay	assessment at 30 days from surgery
IL-6	Immune response to tissue trauma (Interleukin-6)	change from baseline at 2,6,24 and 72 hours from surgery
IL-8	Interleukin-8	change from baseline at 2,6,24 and 72 hours from surgery
WBCC	White Blood Cell Count	change from baseline at 2,6,24 and 72 hours from surgery
CRP	C-reactive Protein	change from baseline at 2,6,24 and 72 hours from surgery

Collaborators and Investigators

• Sponsor: North Tees and Hartlepool NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: laparoscopic surgery; single-port access; surgical trauma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: SUR-089