Clinical trial NCT04961411: Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm
Official title: Colonic Gallstone Ileus: a Literature Review With a Diagnostic-therapeutic Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gall Stone
Keywords: Gallstone ileus
Cholecystocolonic fistula
Risk factors
Diagnosis
Therapy
Algorithm
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will take data from all accessible published case and case series with complete description of colonic gallstone ileus

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Demographic data
timeFrame: up to 8 weeks
measure: Gallstone size
timeFrame: up to 8 weeks
measure: Symptoms
timeFrame: up to 8 weeks
measure: Obstruction level
timeFrame: up to 8 weeks
measure: Risk factors and comorbidities
timeFrame: up to 8 weeks
measure: Diagnostics - clinical exam
timeFrame: up to 8 weeks
measure: Diagnostics - endoscopy
timeFrame: up to 8 weeks
measure: Diagnostics - x-ray
timeFrame: up to 8 weeks
measure: Diagnostics - computed tomography
timeFrame: up to 8 weeks
measure: Diagnostics - specific signs
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Therapeutic options - operation without resection
timeFrame: up to 8 weeks
measure: Therapeutic options - operation with resection
timeFrame: up to 8 weeks
measure: Therapeutic options - conservative treatment
timeFrame: up to 8 weeks
measure: Survival
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University hospital center Zagreb
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Goran Augustin, M.D., Ph.D
role: STUDY_DIRECTOR
References: