Intraabdominal Abscess After ProcedureNCT05011630
Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary
An observational study of Intraabdominal Abscess After Procedure, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intraabdominal Abscess After Procedure
- What is being tested?
- Pancreaticoduodenectomy
- How many people
- 539 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical populations
Who may be able to join
- all pancreaticoduodenectomy patients
Who cannot join
- no bile cultures
About this study
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
- Being tested
- Pancreaticoduodenectomy
- Keywords
- pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
- Medical subject headings
- Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyOther
The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pancreaticoduodenectomy | |
| Non-IAA group | No IAA formation Receives: Other: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraabdominal abscess
The abscess formation after surgery
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jan 2007
- Primary completion31 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal Abscess After ProcedureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Ming Wu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011630
- Sponsor's protocol ID
- 201803035RIND
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary
- ClinicalTrials.gov ID
- NCT05011630
- Acronym / sponsor ID
- 201803035RIND
- Conditions
- Intraabdominal Abscess After Procedure
- Keywords
- pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAA group | – | Other: PancreaticoduodenectomyIntraabdominal 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. |
| Non-IAA group | – | Other: PancreaticoduodenectomyNo IAA formation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical populations
Key inclusion criteria (1 listed)
- all pancreaticoduodenectomy patients
Key exclusion criteria (1 listed)
- no bile cultures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreaticoduodenectomyThe incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA | Other | IAA group, Non-IAA group |
Primary outcome
Intraabdominal abscess
Time frame: 1 month after surgery
The abscess formation after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Ming Wu, MD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Abscess After Procedure, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraabdominal abscess (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.