Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

NCT ID: NCT05011630

Last Updated: 2021-08-18

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

COMPLETED

Total Enrollment

539 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2021-06-30

Brief Summary

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Background Intra-abdominal abscess (IAA) is one of the most serious surgical infectious complications on pancreaticoduodenectomy (PD) patients. Preoperative biliary drainage (PBD) is considered as a risk of surgical infectious complications. However, the reason why PBD caused IAA was unknown. In this study, we hypothesize that bile contamination may increase the rate of IAA as bile from residual common bile duct (CBD) leaks and contaminates the abdominal cavity.

Methods We retrospectively collected PD patients with performance of bile culture between 2007 and 2019 in our institute. As to bile culture, we used a swab to do intraoperative bile cultures after transection of the CBD. IAA was defined as a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.

Detailed Description

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Conditions

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Intraabdominal Abscess After Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IAA group

Intraabdominal abscess (IAA) is defined as either a turbid discharge from the intraoperatively placed drain or a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.

Pancreaticoduodenectomy

Intervention Type OTHER

The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

Non-IAA group

No IAA formation

Pancreaticoduodenectomy

Intervention Type OTHER

The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

Interventions

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Pancreaticoduodenectomy

The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all pancreaticoduodenectomy patients

Exclusion Criteria

* no bile cultures
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin-Ming Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Other Identifiers

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201803035RIND

Identifier Type: -

Identifier Source: org_study_id

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