Study for Rapid Diagnosis of Postoperative Abdominal Infection

Establishment and Research for Rapid Diagnosis of Postoperative Abdominal Infection Based on Metagenomic Sequencing

This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Infection; Abdominal Surgery; Intra-abdominal Infection; Postoperative Fever

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients receive abdominal surgery including pancreatic, gastrointestinal, biliary surgery, etc. with routinely placing abdominal drainage in Peking Union Medical College Hospital. They are clinically suspected with postoperative abdominal infection.

Description

Inclusion Criteria:

1. Patients who receive abdominal operations with routinely abdominal drainage placement.

2. Abdominal infection is suspected by the clinicians, and one of the following conditions is met:

   1. Temperature ≥38℃;
   2. One of the following laboratory indicators: WBC≥10×10^9/L, PCT≥0.5ng/ml, hsCRP≥100mg/L.

Exclusion Criteria:

1. Patients who are diagnosed with the abdominal infection before surgery.
2. Evidence of non-abdominal infection is clear and could explain the clinical symptoms.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The pathogenic spectrum of postoperative abdominal infection	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Consistency between mNGS and conventional culture methods	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections
• Other Study ID Numbers: SRDPAI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No