Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm

Gall Stone Clinical Trial

Official title:

Colonic Gallstone Ileus: a Literature Review With a Diagnostic-therapeutic Algorithm

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04961411
• Other study ID #: 01012021
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2021
• Source: Clinical Hospital Centre Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: July 31, 2021
• Est. primary completion date: June 1, 2021
• 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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Stone
• Gallstones

Intervention

Procedure:
• operation or non-operative treatment
type of operation or if possible non-operative treatment

Locations

Country	Name	City	State
Croatia	University hospital center Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Tomislav Bruketa

Country where clinical trial is conducted

Croatia, 

Outcome

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