Surgical Stress and Colorectal Surgery (ESSIMIC)

Federico II University

Status

Unknown

Conditions

Surgical Stress and Immune Function

Treatments

Procedure: Robotic and Laparoscopic Colectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02871960

RoboticUnina2016

Details and patient eligibility

About

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

Full 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).

Enrollment

170 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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.