Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm

NCT04961411 | Unknown

• 1 other identifier: 01012021
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Gall Stone

Keywords

Gallstone ileus; Cholecystocolonic fistula; Risk factors; Diagnosis; Therapy; Algorithm

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Therapeutic options - operation without resection

  up to 8 weeks

• Therapeutic options - operation with resection

  up to 8 weeks

• Therapeutic options - conservative treatment

  up to 8 weeks

• Survival

  up to 8 weeks

Study Arms (1)

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

Interventions

operation or non-operative treatment PROCEDURE

type of operation or if possible non-operative treatment

published cases of patients with gallstone ileus

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• all published cases and case series with a complete description of colonic gallstone ileus

You may not qualify if:

• small bowel gallstone ileus; gastric outlet gallstone ileus; non-gallstone intraluminal obstruction; and cholecystocolonic fistula without colonic gallstone ileus

Sponsors & Collaborators

• Tomislav Bruketa: lead

Study Sites (1)

University hospital center Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Gallstones; Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Goran Augustin, M.D., Ph.D

  Clinical Hospital Centre Zagreb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General and abdominaln surgeon, M.D., Ph.D.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 14, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 31, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: With publication with no time limit

Locations

CR (1)