Gall StoneNCT04961411
Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm
An observational study of Gall Stone, run by Tomislav Bruketa at 1 site in Croatia.
Trial summary
Gallstone ileus is a rare complication of gallstone disease. There is no systematic review on CGI. We analyze published literature on the subject and plan to propose a diagnostic-therapeutic algorithm for CGI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gall Stone
- What is being tested?
- operation or non-operative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2021to 31 Jul 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: We will take data from all accessible published case and case series with complete description of colonic gallstone ileus
Who may be able to join
- all published cases and case series with a complete description of colonic gallstone ileus
Who cannot join
- small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colonic Gallstone Ileus: a Literature Review With a Diagnostic-therapeutic Algorithm
Gallstone ileus is a rare complication of gallstone disease. There is no systematic review on CGI. We analyze published literature on the subject and plan to propose a diagnostic-therapeutic algorithm for CGI. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and AMSTAR (Assessing the methodological quality of systematic reviews) guidelines, we will performe a systematic review of English-, German-, Spanish-, Japanese-, and Italian-language articles using PubMed (1946-2021), PubMed Central (1900-2021), and Google Scholar.
The search items include 'gallstone ileus', 'colonic gallstone ileus', 'gallstone coleus', 'cholecystocolonic fistula', 'ileo biliar', 'iléus biliaire', 'ileo di calcoli biliary', 'galsteen ileus', 'fístula colecistocolônica', 'fistule cholécystocolique'. Additional studies will be identified by reviewing reference lists of retrieved studies. We will include all cases and case series with a complete description of CGI.
Read more
Exclusion criteria: (1) small bowel gallstone ileus; (2) gastric outlet gallstone ileus; (3) non-gallstone intraluminal obstruction; and (4) cholecystocolonic fistula without CGI.
The primary outcome: a relationship of demographic data, gallstone size, symptoms, obstruction level, risk factors, and comorbidities (biliary history, diverticular disease, cardiovascular disease, radiation of pelvis), diagnostics (palpable mass in the abdomen and rectal exam, laboratory tests, sigmoidoscopy/colonoscopy, x-ray, computed tomography (CT), colonic Rigler's triad) with the correct diagnosis.
The secondary outcome: the identification of therapeutic options and related survival.
The third outcome: to develop a comprehensive diagnostic-therapeutic algorithm for CGI.
The study is exempt from ethics approval because we synthesized data from published studies.
- Conditions
- Gall Stone
- Being tested
- operation or non-operative treatment
- Keywords
- Gallstone ileus, Cholecystocolonic fistula, Risk factors, Diagnosis, Therapy, Algorithm
- Medical subject headings
- Gallstones, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operation or non-operative treatmentProcedure or surgery
type of operation or if possible non-operative treatment
| Study group | Role | What they receive |
|---|---|---|
| published cases of patients with gallstone ileus | We will observe clinical signs, diagnostic procedures and therapeutic procedures and options Receives: Procedure: operation or non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
male to female ratio
Measured: up to 8 weeks
Gallstone size
gallstone size
Measured: up to 8 weeks
Symptoms
possible disease presentation
Measured: up to 8 weeks
Obstruction level
level of obstruction in colon
Measured: up to 8 weeks
Risk factors and comorbidities
biliary history, diverticular disease
Measured: up to 8 weeks
Diagnostics - clinical exam
palpable mass in the abdomen
Measured: up to 8 weeks
Diagnostics - endoscopy
Colonoscopy
Measured: up to 8 weeks
Diagnostics - x-ray
plain abdominal x-ray
Measured: up to 8 weeks
Diagnostics - computed tomography
Abdominal computed tomography
Measured: up to 8 weeks
Diagnostics - specific signs
Colonic Rigler's triad
Measured: up to 8 weeks
Secondary outcomes (4)
Therapeutic options - operation without resection
number of patients with cololithotomy
Measured: up to 8 weeks
Therapeutic options - operation with resection
number of patients with colonic resection
Measured: up to 8 weeks
Therapeutic options - conservative treatment
number of patients treated conservatively
Measured: up to 8 weeks
Survival
Survival of patients according to therapeutic option
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall StoneStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomislav Bruketa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tomislav Bruketa, Clinical Hospital Centre Zagreb
- Investigators
- Goran Augustin, M.D., Ph.D, Study director, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961411
- Sponsor's protocol ID
- 01012021
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As a supplement data with publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Gallstone Ileus: a Literature Review With a Diagnostic-therapeutic Algorithm
- ClinicalTrials.gov ID
- NCT04961411
- Acronym / sponsor ID
- 01012021
- Conditions
- Gall Stone
- Keywords
- Gallstone ileus, Cholecystocolonic fistula, Risk factors, Diagnosis, Therapy, Algorithm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Tomislav BruketaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 14 Jul 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.
Gallstone ileus is a rare complication of gallstone disease. There is no systematic review on CGI. We analyze published literature on the subject and plan to propose a diagnostic-therapeutic algorithm for CGI. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and AMSTAR (Assessing the methodological quality of systematic reviews) guidelines, we will performe a systematic review of English-, German-, Spanish-, Japanese-, and Italian-language articles using PubMed (1946-2021), PubMed Central (1900-2021), and Google Scholar.
The search items include 'gallstone ileus', 'colonic gallstone ileus', 'gallstone coleus', 'cholecystocolonic fistula', 'ileo biliar', 'iléus biliaire', 'ileo di calcoli biliary', 'galsteen ileus', 'fístula colecistocolônica', 'fistule cholécystocolique'. Additional studies will be identified by reviewing reference lists of retrieved studies. We will include all cases and case series with a complete description of CGI.
Exclusion criteria: (1) small bowel gallstone ileus; (2) gastric outlet gallstone ileus; (3) non-gallstone intraluminal obstruction; and (4) cholecystocolonic fistula without CGI.
The primary outcome: a relationship of demographic data, gallstone size, symptoms, obstruction level, risk factors, and comorbidities (biliary history, diverticular disease, cardiovascular disease, radiation of pelvis), diagnostics (palpable mass in the abdomen and rectal exam, laboratory tests, sigmoidoscopy/colonoscopy, x-ray, computed tomography (CT), colonic Rigler's triad) with the correct diagnosis.
The secondary outcome: the identification of therapeutic options and related survival.
The third outcome: to develop a comprehensive diagnostic-therapeutic algorithm for CGI.
The study is exempt from ethics approval because we synthesized data from published studies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| published cases of patients with gallstone ileus | – | Procedure: operation or non-operative treatmentWe will observe clinical signs, diagnostic procedures and therapeutic procedures and options |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- We will take data from all accessible published case and case series with complete description of colonic gallstone ileus
Key inclusion criteria (1 listed)
- all published cases and case series with a complete description of colonic gallstone ileus
Key exclusion criteria (1 listed)
- small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus
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 |
|---|---|---|
| operation or non-operative treatmenttype of operation or if possible non-operative treatment | Procedure or surgery | published cases of patients with gallstone ileus |
Primary outcome
Demographic data
Time frame: up to 8 weeks
male to female ratio
Gallstone size
Time frame: up to 8 weeks
gallstone size
Symptoms
Time frame: up to 8 weeks
possible disease presentation
Obstruction level
Time frame: up to 8 weeks
level of obstruction in colon
Risk factors and comorbidities
Time frame: up to 8 weeks
biliary history, diverticular disease
Diagnostics - clinical exam
Time frame: up to 8 weeks
palpable mass in the abdomen
Diagnostics - endoscopy
Time frame: up to 8 weeks
Colonoscopy
Diagnostics - x-ray
Time frame: up to 8 weeks
plain abdominal x-ray
Diagnostics - computed tomography
Time frame: up to 8 weeks
Abdominal computed tomography
Diagnostics - specific signs
Time frame: up to 8 weeks
Colonic Rigler's triad
4 secondary outcomes
Therapeutic options - operation without resection
Time frame: up to 8 weeks
Therapeutic options - operation with resection
Time frame: up to 8 weeks
Therapeutic options - conservative treatment
Time frame: up to 8 weeks
Survival
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: Yes. As a supplement data with publication
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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.
Goran Augustin, M.D., Ph.D study director
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gall Stone, run by Tomislav Bruketa at 1 site in Croatia.
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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Demographic data (time frame: up to 8 weeks). The study lists 10 primary outcomes in all. 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 14 Jul 2021.