Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases

Sponsor
University Hospital of Patras (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04748744
Collaborator
(none)
200
1
48.8
4.1

Study Details

Study Description

Brief Summary

Butyrylcholinesterase (BChE) is an α-glycoprotein synthesized in the liver. BchE's 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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Butyrylcholinesterase

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases
Actual Study Start Date :
Nov 6, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing colorectal surgery

Combination Product: Butyrylcholinesterase
Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases

Outcome Measures

Primary Outcome Measures

  1. Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases [November 6th 2019 to March 1st 2023]

    Blood samples will be collected preoperatively by the investigators (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 serum BChE. The normal range of this BchE in our laboratory is 2.8-7.4 KU/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Operation for colorectal disease

  • Older than 18 years old

Exclusion Criteria:
  • Younger than 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Francesk Mulita Patras Achaia Greece 26223

Sponsors and Collaborators

  • University Hospital of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francesk Mulita, Principal Investigator, University Hospital of Patras
ClinicalTrials.gov Identifier:
NCT04748744
Other Study ID Numbers:
  • 4025
First Posted:
Feb 10, 2021
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Francesk Mulita, Principal Investigator, University Hospital of Patras
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2021