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

NCT05011630 | Completed

• 1 other identifier: 201803035RIND
• Study Type: observational
• Target: 539
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraabdominal Abscess After Procedure

Keywords

pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication

Outcome Measures

Primary Outcomes (1)

• Intraabdominal abscess

  The abscess formation after surgery

  1 month after surgery

Study Arms (2)

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.

Other: Pancreaticoduodenectomy

Non-IAA group

No IAA formation

Other: Pancreaticoduodenectomy

Interventions

Pancreaticoduodenectomy OTHER

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

IAA group; Non-IAA group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical populations

You may qualify if:

• all pancreaticoduodenectomy patients

You may not qualify if:

• no bile cultures

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Abdominal Abscess

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jin-Ming Wu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 18, 2021
• Study Start: January 1, 2007
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share