Study for Rapid Diagnosis of Postoperative Abdominal Infection

• Conditions: Postoperative Fever; Postoperative Infection; Abdominal Surgery; Intra-abdominal Infection

• Registration Number: NCT05187871
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Status Verified: 2021-11
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2022-01-12
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The pathogenic spectrum of postoperative abdominal infection	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Consistency between mNGS and conventional culture methods	Through study completion, an average of 1 year

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China