Single-port Versus Conventional Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Inflammatory Bowel Disease, Benign Colorectal Neoplasm, Diverticular Disease

Intervention / Treatment
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* Procedure: Single-port access surgery
* Procedure: Conventional Laparoscopic Access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPA<br>Single-port access surgery | Procedure: Single-port access surgery<br>* Surgery carried out through a single incision laparoscopic approach<br>|
| Active Comparator: CL<br>Conventional Laparoscopic access | Procedure: Conventional Laparoscopic Access<br>* Surgery through standard multiport laparoscopic approach<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-port access, laparoscopic surgery, surgical trauma