Overview

This trial is active, not recruiting.

Condition surgical stress and immune function
Treatment robotic and laparoscopic colectomy
Phase phase 2
Sponsor Federico II University
Start date July 2016
End date July 2017
Trial size 100 participants
Trial identifier NCT02871960, RoboticUnina2016

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergoing robotic colectomy for colorectal cancer
robotic and laparoscopic colectomy
(Active Comparator)
Patients undergoing laparoscopic colectomy for colorectal cancer
robotic and laparoscopic colectomy

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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.

Additional Information

Official title Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Federico II University.