Study for Rapid Diagnosis of Postoperative Abdominal Infection

NCT05187871 | Unknown

• 1 other identifier: SRDPAI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Infection; Abdominal Surgery; Intra-abdominal Infection; Postoperative Fever

Outcome Measures

Primary Outcomes (1)

• The pathogenic spectrum of postoperative abdominal infection

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Consistency between mNGS and conventional culture methods

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who receive abdominal operations with routinely abdominal drainage placement.
• Abdominal infection is suspected by the clinicians, and one of the following conditions is met:
• Temperature ≥38℃;
• One of the following laboratory indicators: WBC≥10×10\^9/L, PCT≥0.5ng/ml, hsCRP≥100mg/L.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 37288562 DERIVED

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 12, 2022
• Study Start: August 10, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 15, 2022

Record last verified: 2021-11

Locations

CN (1)