Clinical trial NCT02871960: Surgical Stress and Colorectal Surgery
Official title: Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Stress and Immune Function
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: interleukin 1
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: interleukin 6
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: Tumor necrosis factor alpha
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: C-reactive protein
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: fibrinogen
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: prolactin
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: cortisol
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: insulin
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: glucagon
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: Adrenocorticotropic hormone
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: Growth hormone
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
measure: human leukocyte antigen
timeFrame: change between time before surgery, 24 hours after surgery, 72 hours after surgery
Secondary outcomes:
Other outcomes:
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