Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Gall Stone
• Intervention / Treatment: Procedure: operation or non-operative treatment

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
published cases of patients with gallstone ileus; We will observe clinical signs, diagnostic procedures and therapeutic procedures and options	Procedure: operation or non-operative treatment; type of operation or if possible non-operative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	male to female ratio	up to 8 weeks
Gallstone size	gallstone size	up to 8 weeks
Symptoms	possible disease presentation	up to 8 weeks
Obstruction level	level of obstruction in colon	up to 8 weeks
Risk factors and comorbidities	biliary history, diverticular disease	up to 8 weeks
Diagnostics - clinical exam	palpable mass in the abdomen	up to 8 weeks
Diagnostics - endoscopy	Colonoscopy	up to 8 weeks
Diagnostics - x-ray	plain abdominal x-ray	up to 8 weeks
Diagnostics - computed tomography	Abdominal computed tomography	up to 8 weeks
Diagnostics - specific signs	Colonic Rigler's triad	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic options - operation without resection	number of patients with cololithotomy	up to 8 weeks
Therapeutic options - operation with resection	number of patients with colonic resection	up to 8 weeks
Therapeutic options - conservative treatment	number of patients treated conservatively	up to 8 weeks
Survival	Survival of patients according to therapeutic option	up to 8 weeks

Collaborators and Investigators

• Sponsor: Tomislav Bruketa
• Investigators: Study Director: Goran Augustin, M.D., Ph.D, Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Diagnosis; Risk factors; Therapy; Algorithm; Gallstone ileus; Cholecystocolonic fistula
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 01012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As a supplement data with publication
• IPD Sharing Time Frame: With publication with no time limit
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No