Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

NCT ID: NCT03862378

Last Updated: 2019-06-11

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

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In our previous study, a nomogram model was established to predict intra-abdominal infectious complications after gastrointestinal surgery. This model was based on the clinical data and the drainage fluid cytokine levels, and it received an AUC \>0.9. In this study, validation of this nomogram is planned to be conducted in this prospective cohort study.

Detailed Description

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Intra-abdominal infectious complications such as anastomotic leakage are the most feared but common complications after gastrointestinal surgery. In our previous study, a nomogram model was established to predict intra-abdominal complications after gastrointestinal surgery. This model was based on the clinical data and the drainage fluid cytokine levels, and it received an AUC \>0.9. A predicting score (i.e. APPEAL-GC score) was created based on the model. In this study, validation of this score in predicting intra-abdominal complications is planned to be conducted in this prospective cohort study.

In this study, all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included. The clinical data and complication data will be prospectively collected; the discarded drainage fluid will be collected and analyzed afterward. No additional intervention will be applied.

The cytokine levels in the drainage fluid will be evaluated, and together with the clinical data, an APPEAL-GC score will be created for each patient. We will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery. The predictive value (clinical usefulness) of the score will be validated in this study.

Conditions

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Complication Anastomotic Leak Intraabdominal Infections Inflammatory Response Gastrointestinal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group One

All patients underwent gastric or colorectal cancer surgery in the participating centers will be included. Clinical data, drainage cytokine levels will be recorded.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Planned surgery for gastric or colorectal cancer with primary anastomosis.
* Inform consent signed before surgery.

Exclusion Criteria

* No drainage tube placed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Ziyu Li, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziyu Li, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhouqiao Wu, MD PhD

Role: CONTACT

0086-10-88196606

Facility Contacts

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Zhouqiao Wu, M.D.

Role: primary

86-010-8819-6606

Ziyu Li, M.D.

Role: backup

86-010-8819-6605

Other Identifiers

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2016YJZ32

Identifier Type: -

Identifier Source: org_study_id

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