Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm
- Conditions
- Gall Stone
- Interventions
- Procedure: operation or non-operative treatment
- Registration Number
- NCT04961411
- Lead Sponsor
- Tomislav Bruketa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 113
- all published cases and case series with a complete description of colonic gallstone ileus
- small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description published cases of patients with gallstone ileus operation or non-operative treatment We will observe clinical signs, diagnostic procedures and therapeutic procedures and options
- Primary Outcome Measures
Name Time Method Gallstone size up to 8 weeks gallstone size
Symptoms up to 8 weeks possible disease presentation
Obstruction level up to 8 weeks level of obstruction in colon
Risk factors and comorbidities up to 8 weeks biliary history, diverticular disease
Diagnostics - clinical exam up to 8 weeks palpable mass in the abdomen
Diagnostics - endoscopy up to 8 weeks Colonoscopy
Diagnostics - x-ray up to 8 weeks plain abdominal x-ray
Diagnostics - computed tomography up to 8 weeks Abdominal computed tomography
Diagnostics - specific signs up to 8 weeks Colonic Rigler's triad
Demographic data up to 8 weeks male to female ratio
- Secondary Outcome Measures
Name Time Method Therapeutic options - operation without resection up to 8 weeks number of patients with cololithotomy
Therapeutic options - conservative treatment up to 8 weeks number of patients treated conservatively
Survival up to 8 weeks Survival of patients according to therapeutic option
Therapeutic options - operation with resection up to 8 weeks number of patients with colonic resection
Trial Locations
- Locations (1)
University hospital center Zagreb
🇭🇷Zagreb, Croatia