Surgical Stress and Colorectal Surgery
- Conditions
- Surgical Stress and Immune Function
- Interventions
- Procedure: Robotic and Laparoscopic Colectomy
- Registration Number
- NCT02871960
- Lead Sponsor
- Federico II University
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 170
- Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic colectomy Robotic and Laparoscopic Colectomy Patients undergoing laparoscopic colectomy for colorectal cancer Robotic colectomy Robotic and Laparoscopic Colectomy Patients undergoing robotic colectomy for colorectal cancer
- Primary Outcome Measures
Name Time Method interleukin 1 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 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 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
- Secondary Outcome Measures
Name Time Method