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

Completed

• Conditions: Intraabdominal Abscess After Procedure
• Interventions: Other: Pancreaticoduodenectomy

• Registration Number: NCT05011630
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-15
• Study First Submitted QC: 2021-08-15
• Last Update Submitted: 2021-08-15
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

Inclusion Criteria

• all pancreaticoduodenectomy patients

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Exclusion Criteria

• no bile cultures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-IAA group	Pancreaticoduodenectomy	No IAA formation
IAA group	Pancreaticoduodenectomy	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.

Primary Outcome Measures

Name	Time	Method
Intraabdominal abscess	1 month after surgery	The abscess formation after surgery