Surgical Stress and Colorectal Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.

Detailed Description
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The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of robotic surgery. Robotic approaches have seen significant growth in the last 5 years. Taking advantage of three-dimensional visualization, improved articulation, and multiple operating arms provides theoretical advantages in colorectal cancer surgery. In an attempt to evaluate the surgical stress response and immune function after robotic colorectal surgery a comparative study has been designed. Two surgical procedures were evaluated: Robotic colorectal resection (Experimental group) and Laparoscopic colorectal resection (Control group).

Official Title
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Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)

Conditions
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Surgical Stress and Immune Function

Intervention / Treatment
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* Procedure: Robotic and Laparoscopic Colectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy Exclusion Criteria: Patients with a previous midline laparotomy, emergency surgery, or immune depressant disease or medication will be excluded from this study. Peri-operative or post-operative complications will be considered exclusion criteria.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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: Robotic colectomy<br>Patients undergoing robotic colectomy for colorectal cancer | Procedure: Robotic and Laparoscopic Colectomy<br> <br> |
| Active Comparator: Laparoscopic colectomy<br>Patients undergoing laparoscopic colectomy for colorectal cancer | Procedure: Robotic and Laparoscopic Colectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin 1 |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| interleukin 6 |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| Tumor necrosis factor alpha |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| C-reactive protein |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| fibrinogen |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| prolactin |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| cortisol |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| insulin |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| glucagon |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| Adrenocorticotropic hormone |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| Growth hormone |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery | 
| human leukocyte antigen |  | change between time before surgery, 24 hours after surgery, 72 hours after surgery |