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

Federico II University0 sites170 target enrollmentJanuary 2016

ConditionsSurgical Stress and Immune Function

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgical Stress and Immune Function
Sponsor: Federico II University
Enrollment: 170
Primary Endpoint: interleukin 1
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

November 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Federico II University

Responsible Party

Principal Investigator

Francesco Milone

Professor of Surgery

Federico II University

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.