Single-port Versus Conventional Laparoscopic Colorectal Surgery

Phase 1

• Conditions: Colorectal Cancer; Benign Colorectal Neoplasm; Diverticular Disease; Inflammatory Bowel Disease
• Interventions: Procedure: Conventional Laparoscopic Access; Procedure: Single-port access surgery

• Registration Number: NCT01626963
• Lead Sponsor: North Tees and Hartlepool NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Study Start: 2014-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-24
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CL	Conventional Laparoscopic Access	Conventional Laparoscopic access
SPA	Single-port access surgery	Single-port access surgery

Primary Outcome Measures

Name	Time	Method
Operative Time	assessment of electronic records at 30 days from surgery	Operative Time

Secondary Outcome Measures

Name	Time	Method
Pain scores	change from baseline at 1,2,3,4 and 5 days from surgery	Pain scores on visual Analog Scale
Complication / Conversion-to-open-surgery rates	assessment at 30 days post-op	Complication / Conversion-to-open-surgery rates
Quality of Life indicators	change from baseline at 2, 4 weeks, & 3 months after surgery	Quality of Life indicators
Cosmetic appearance	change from baseline at 2, 4 weeks and three months after surgery	Body-Image scale
Cost comparison	assessment at the end of the study, up to 2 years post-op	Assessment of overall cost, including theatre time, disposable equipment and length of hospital stay
LoS	assessment at 30 days from surgery	Length of hospital stay
IL-6	change from baseline at 2,6,24 and 72 hours from surgery	Immune response to tissue trauma (Interleukin-6)
IL-8	change from baseline at 2,6,24 and 72 hours from surgery	Interleukin-8
CRP	change from baseline at 2,6,24 and 72 hours from surgery	C-reactive Protein
WBCC	change from baseline at 2,6,24 and 72 hours from surgery	White Blood Cell Count

Trial Locations

Locations (1)

University Hospital North Tees; 🇬🇧 Stockton on Tees, United Kingdom