Colonic Gallstone Ileus, Diagnostic-therapeutic Algorithm

T

Tomislav Bruketa

Status

Unknown

Conditions

Gall Stone

Treatments

Procedure: operation or non-operative treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04961411
01012021

Details and patient eligibility

About

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.

Enrollment

113 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

113 participants in 1 patient group

published cases of patients with gallstone ileus
Description:
We will observe clinical signs, diagnostic procedures and therapeutic procedures and options
Treatment:
Procedure: operation or non-operative treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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