Gall Stone Clinical Trial
Official title:
Colonic Gallstone Ileus: a Literature Review With a Diagnostic-therapeutic Algorithm
Verified date | July 2021 |
Source | Clinical Hospital Centre Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 113 |
Est. completion date | July 31, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - all published cases and case series with a complete description of colonic gallstone ileus Exclusion Criteria: - small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus |
Country | Name | City | State |
---|---|---|---|
Croatia | University hospital center Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Tomislav Bruketa |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demographic data | male to female ratio | up to 8 weeks | |
Primary | Gallstone size | gallstone size | up to 8 weeks | |
Primary | Symptoms | possible disease presentation | up to 8 weeks | |
Primary | Obstruction level | level of obstruction in colon | up to 8 weeks | |
Primary | Risk factors and comorbidities | biliary history, diverticular disease | up to 8 weeks | |
Primary | Diagnostics - clinical exam | palpable mass in the abdomen | up to 8 weeks | |
Primary | Diagnostics - endoscopy | Colonoscopy | up to 8 weeks | |
Primary | Diagnostics - x-ray | plain abdominal x-ray | up to 8 weeks | |
Primary | Diagnostics - computed tomography | Abdominal computed tomography | up to 8 weeks | |
Primary | Diagnostics - specific signs | Colonic Rigler's triad | up to 8 weeks | |
Secondary | Therapeutic options - operation without resection | number of patients with cololithotomy | up to 8 weeks | |
Secondary | Therapeutic options - operation with resection | number of patients with colonic resection | up to 8 weeks | |
Secondary | Therapeutic options - conservative treatment | number of patients treated conservatively | up to 8 weeks | |
Secondary | Survival | Survival of patients according to therapeutic option | up to 8 weeks |
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