Study for Rapid Diagnosis of Postoperative Abdominal Infection

NCT ID: NCT05187871

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-10

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Postoperative Infection Abdominal Surgery Intra-abdominal Infection Postoperative Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Zhu R, Hong X, Zhang D, Xiao Y, Xu Q, Wu B, Guo J, Han X, Yang Q, Zhao Y, Wu W. Application of metagenomic sequencing of drainage fluid in rapid and accurate diagnosis of postoperative intra-abdominal infection: a diagnostic study. Int J Surg. 2023 Sep 1;109(9):2624-2630. doi: 10.1097/JS9.0000000000000500.

Reference Type DERIVED
PMID: 37288562 (View on PubMed)

Other Identifiers

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SRDPAI

Identifier Type: -

Identifier Source: org_study_id

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