Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-22 @ 9:42 PM
Study NCT ID:
NCT02871960
Status:
UNKNOWN
Last Update Posted:
2020-01-22
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Stress and Colorectal Surgery
Sponsor:
Federico II University
Organization:
Study Overview
Official Title:
Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESSIMIC
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: