Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000964112
Ethics application status
Approved
Date submitted
7/06/2019
Date registered
8/07/2019
Date last updated
8/07/2019
Date data sharing statement initially provided
8/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gallstone ileus: Management and clinical outcomes
Scientific title
Gallstone ileus: Management and clinical outcomes
Secondary ID [1] 298445 0
None
Universal Trial Number (UTN)
U1111-1234-9269
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Gallstone Ileus 313182 0
Condition category
Condition code
Surgery 311642 311642 0 0
Other surgery
Oral and Gastrointestinal 311779 311779 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation (normal clinical practice) of patients diagnosed with gallstone ileus, analyzing diagnostic and treatment difficulties. Each patient was observed only during their hospital stay.
Intervention code [1] 314688 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320350 0
In-hospital patient mortality for patients with gallstone ileus.
Timepoint [1] 320350 0
Discharge from hospital
Secondary outcome [1] 371285 0
The percentage of correct diagnosis before surgery for patients with gallstone ileus (intraoperative findings vs. preoperative diagnosis) this will be achieved by collecting data from hospital records
Timepoint [1] 371285 0
Discharge from hospital

Eligibility
Key inclusion criteria
Adults (>18 years old) with suspected gallstone ileus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
N/A

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2018
Date of last participant enrolment
Anticipated
Actual
1/09/2018
Date of last data collection
Anticipated
Actual
7/09/2018
Sample size
Target
5
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 21583 0
Lithuania
State/province [1] 21583 0
Vilnius

Funding & Sponsors
Funding source category [1] 302991 0
Self funded/Unfunded
Name [1] 302991 0
N/A
Country [1] 302991 0
Primary sponsor type
Individual
Name
Prof. Tomas Poskus
Address
Vilnius University Hospital "Santaros Klinikos" Santariskiu g 2, LT-08611, Vilnius, Lithuania
Country
Lithuania
Secondary sponsor category [1] 302953 0
None
Name [1] 302953 0
N/A
Address [1] 302953 0
N/A
Country [1] 302953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303541 0
Vilnius Regional Biomedical Research Ethics Committee
Ethics committee address [1] 303541 0
M. K. Ciurlionio str 21/27, LT-03101, Vilnius
Ethics committee country [1] 303541 0
Lithuania
Date submitted for ethics approval [1] 303541 0
Approval date [1] 303541 0
02/03/2018
Ethics approval number [1] 303541 0

Summary
Brief summary
Gallstone or biliary ileus is a late complication of gallstone disease. It accounts for 1-4% of all bowel obstructions and is more common in elderly patients. The preferred treatment option is to mechanically remove the impacted stones. It is done surgically using open or laparoscopic approach and rarely, when stones are impacted in the colon – endoscopically. In this trial we analyze five consecutive cases of gallstone ileus and describe possible diagnostic and minimally invasive treatment options.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94022 0
Prof Tomas Poskus
Address 94022 0
Vilnius University Hospital "Santaros Klinikos" Santariskiu st 2, LT- 08611, Vilnius, Lithuania
Country 94022 0
Lithuania
Phone 94022 0
+37061373978
Fax 94022 0
Email 94022 0
[email protected]
Contact person for public queries
Name 94023 0
Matas Jakubauskas
Address 94023 0
Vilnius University Hospital "Santaros Klinikos" Santariskiu st 2, LT- 08611, Vilnius, Lithuania
Country 94023 0
Lithuania
Phone 94023 0
+37061373999
Fax 94023 0
Email 94023 0
[email protected]
Contact person for scientific queries
Name 94024 0
Matas Jakubauskas
Address 94024 0
Vilnius University Hospital "Santaros Klinikos" Santariskiu st 2, LT- 08611, Vilnius, Lithuania
Country 94024 0
Lithuania
Phone 94024 0
+37052365000
Fax 94024 0
Email 94024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study data contains sensitive information, that cannot be sent to third party authorities without permission.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.