Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748744
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2020-11-03
Brief Title:
Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases
Sponsor:
University Hospital of Patras
Organization:
University Hospital of Patras
Study Overview
Official Title:
Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
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:
None
Brief Summary:
Butyrylcholinesterase BChE is an α-glycoprotein synthesized in the liver BchEs serum level decreases in many clinical conditions such as acute and chronic liver damage inflammation injury and infections and malnutrition The Investigators prospectively evaluate patients undergoing elective procedures for colorectal diseases Blood samples are collected preoperatively at day 0 post-operatively in the recovery room day 1 and on the subsequent four days days 2 3 4 and 5 for assessment of BChE C-reactive protein and white blood cell concentrations The same surgical team operates all patients and is blinded to the study Patients are monitored for post-operative infection by using standard laboratory and clinical methods If surgical site infection SSI is suspected the wound is swabbed and empirical antibiotics are started The aim of the current trial is to study whether BChE is a reliable marker for the presence of SSI in patients undergoing colorectal surgery
Detailed Description:
Butyrylcholinesterase BChE or BuChE is a cholinesterase enzyme that is very similar to acetylcholinesterase AChE However though the role and function of AChE in the human body are widely studied and known BChE is usually referred to as an orphan enzyme because its specific physiological role is still under question Lastly it has been found however that BChE has more specific functions than it was previously believed and acetylcholine ACh which will be further analyzed can affect the immune system and is associated with inflammation-related events Butyrylcholinesterase is an enzyme that for several years was not considered to have a specific physiological role but lately it has been observed that plays an important role in inflammation as acetylcholine is a major player of the cholinergic anti-inflammatory pathway inhibiting inflammation It has been proved that BChE activity can be affected by several diseases Low-grade inflammation is associated with an increase of its levels whereas a reduction is observed when systemic inflammation is present However future research is needed in order to be widely used in clinical practice as a biomarker for several pathological conditions involving inflammation Therefore the aim of this study is to present information about butyrylcholinesterase its function and its role in the human body highlighting its association with inflammation analyzing past studies about this subject The Investigators prospectively evaluate patients undergoing elective procedures for colorectal diseases Blood samples are collected preoperatively at day 0 post-operatively in the recovery room day 1 and on the subsequent four days days 2 3 4 and 5 for assessment of BChE C-reactive protein and white blood cell concentrations The same surgical team operates all patients and is blinded to the study Patients are monitored for post-operative infection by using standard laboratory and clinical methods If surgical site infection SSI is suspected the wound is swabbed and empirical antibiotics are started The aim of the current trial is to study whether BChE is a reliable marker for the presence of SSI in patients undergoing colorectal surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None