SurgeryNCT04582240
Bile Duct Injury Digestif
An observational study of Surgery and Biliary Disease, run by Dr Cipto Mangunkusumo General Hospital.
Trial summary
Data accumulated from medical record collected from January 2008 until December 2018 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery, Biliary Disease, Bile Duct Injury
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients who experienced complication after performed cholecystectomy, open or laparoscopy, related to biliary duct
Who may be able to join
- adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital
Who cannot join
- none
About this study
Official title: Full Data BDI Digestif RSCM
Data accumulated from medical record collected from January 2008 until December 2018
- Conditions
- Surgery, Biliary Disease, Bile Duct Injury, Sepsis, Jaundice, Obstructive
- Being tested
- no intervention
- Medical subject headings
- Gallbladder Diseases, Sepsis, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Mortality Rate of Patients Performed Reconstructive Surgery for the Management of Bile Duct Injury Post-Cholecystectomy
Measured: january 2008 until december 2018
Secondary outcomes (1)
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Most Frequent Anatomical Location of Bile Duct Injury Post-Cholecystectomy
Measured: january 2008 until december 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vania Myralda Giamour Marbun, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582240
- Sponsor's protocol ID
- BDITJML
- Status last verified
- Dec 2020
- First submitted
- 3 Oct 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Data BDI Digestif RSCM
- ClinicalTrials.gov ID
- NCT04582240
- Acronym / sponsor ID
- BDITJML
- Conditions
- Surgery, Biliary Disease, Bile Duct Injury, Sepsis, Jaundice, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Oct 2020 (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.
Data accumulated from medical record collected from January 2008 until December 2018
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients who experienced complication after performed cholecystectomy, open or laparoscopy, related to biliary duct
Key inclusion criteria (1 listed)
- adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Time frame: january 2008 until december 2018
Mortality Rate of Patients Performed Reconstructive Surgery for the Management of Bile Duct Injury Post-Cholecystectomy
1 secondary outcome
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia
Time frame: january 2008 until december 2018
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 3 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Biliary Disease, run by Dr Cipto Mangunkusumo General 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 3 Dec 2020. 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?
Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia (time frame: january 2008 until december 2018). 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 3 Dec 2020.