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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748744
• Other study ID #: 4025
• Status: Completed
• Start date: November 6, 2019
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Operation for colorectal disease

• Older than 18 years old

Exclusion Criteria:

• Younger than 18 years old

Related Conditions & MeSH terms

• Colorectal Disorders
• Colorectal Neoplasms
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Greece	Francesk Mulita	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Mulita F, Liolis E, Akinosoglou K, Tchabashvili L, Maroulis I, Kaplanis C, Vailas M, Panos G. Postoperative sepsis after colorectal surgery: a prospective single-center observational study and review of the literature. Prz Gastroenterol. 2022;17(1):47-51. — View Citation

Panos G, Mulita F, Akinosoglou K, Liolis E, Kaplanis C, Tchabashvili L, Vailas M, Maroulis I. Risk of surgical site infections after colorectal surgery and the most frequent pathogens isolated: a prospective single-centre observational study. Med Glas (Zenica). 2021 Aug 1;18(2):438-443. doi: 10.17392/1348-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases	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	November 6th 2019 to March 1st 2023