Surgical Stress and Immune Function
Conditions
Brief summary
The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.
Detailed description
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).
Interventions
PROCEDURERobotic and Laparoscopic Colectomy
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed