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

NCT04748744 | Completed FDA Drug

• 1 other identifier: 4025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Disorders; Colorectal Neoplasms

Keywords

butyrylcholinesterase

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients undergoing colorectal surgery

Combination Product: Butyrylcholinesterase

Interventions

Butyrylcholinesterase COMBINATION_PRODUCT

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

Patients undergoing colorectal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgical Site Infection in patients older than 18 years old that will have an operation for colorectal disease

You may qualify if:

• Operation for colorectal disease
• Older than 18 years old

You may not qualify if:

• Younger than 18 years old

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

Francesk Mulita

Pátrai, Achaia, 26223, Greece

Location

Related Publications (2)

• 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.

  PMID: 34080408 BACKGROUND

• 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. doi: 10.5114/pg.2021.106083. Epub 2021 May 23.

  PMID: 35371356 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Butyrylcholinesterase deficiency

Interventions

Butyrylcholinesterase

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cholinesterases; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: February 10, 2021
• Study Start: November 6, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

GR (1)