NCT01626963

Single-port Versus Conventional Laparoscopic Colorectal Surgery

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: North Tees and Hartlepool NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Inflammatory Bowel Disease
• Benign Colorectal Neoplasm
• Diverticular Disease

Interventions

Type	Name	Description
PROCEDURE	Single-port access surgery	Surgery carried out through a single incision laparoscopic approach
PROCEDURE	Conventional Laparoscopic Access	Surgery through standard multiport laparoscopic approach

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2012-06-25
• Last updated: 2016-03-24

Locations

1 site across 1 country: United Kingdom