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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Zagreb, Kroatia, 10000
- University Hospital Center Zagreb
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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published cases of patients with gallstone ileus
We will observe clinical signs, diagnostic procedures and therapeutic procedures and options
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type of operation or if possible non-operative treatment
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Demographic data
Tidsramme: up to 8 weeks
|
male to female ratio
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up to 8 weeks
|
|
Gallstone size
Tidsramme: up to 8 weeks
|
gallstone size
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up to 8 weeks
|
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Symptoms
Tidsramme: up to 8 weeks
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possible disease presentation
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up to 8 weeks
|
|
Obstruction level
Tidsramme: up to 8 weeks
|
level of obstruction in colon
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up to 8 weeks
|
|
Risk factors and comorbidities
Tidsramme: up to 8 weeks
|
biliary history, diverticular disease
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up to 8 weeks
|
|
Diagnostics - clinical exam
Tidsramme: up to 8 weeks
|
palpable mass in the abdomen
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up to 8 weeks
|
|
Diagnostics - endoscopy
Tidsramme: up to 8 weeks
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Colonoscopy
|
up to 8 weeks
|
|
Diagnostics - x-ray
Tidsramme: up to 8 weeks
|
plain abdominal x-ray
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up to 8 weeks
|
|
Diagnostics - computed tomography
Tidsramme: up to 8 weeks
|
Abdominal computed tomography
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up to 8 weeks
|
|
Diagnostics - specific signs
Tidsramme: up to 8 weeks
|
Colonic Rigler's triad
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up to 8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Therapeutic options - operation without resection
Tidsramme: up to 8 weeks
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number of patients with cololithotomy
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up to 8 weeks
|
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Therapeutic options - operation with resection
Tidsramme: up to 8 weeks
|
number of patients with colonic resection
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up to 8 weeks
|
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Therapeutic options - conservative treatment
Tidsramme: up to 8 weeks
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number of patients treated conservatively
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up to 8 weeks
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Survival
Tidsramme: up to 8 weeks
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Survival of patients according to therapeutic option
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up to 8 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Goran Augustin, M.D., Ph.D, Clinical Hospital Centre Zagreb
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 01012021
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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