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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Zagreb, Kroatien, 10000
- University Hospital Center Zagreb
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
published cases of patients with gallstone ileus
We will observe clinical signs, diagnostic procedures and therapeutic procedures and options
|
type of operation or if possible non-operative treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Demographic data
Tidsram: up to 8 weeks
|
male to female ratio
|
up to 8 weeks
|
|
Gallstone size
Tidsram: up to 8 weeks
|
gallstone size
|
up to 8 weeks
|
|
Symptoms
Tidsram: up to 8 weeks
|
possible disease presentation
|
up to 8 weeks
|
|
Obstruction level
Tidsram: up to 8 weeks
|
level of obstruction in colon
|
up to 8 weeks
|
|
Risk factors and comorbidities
Tidsram: up to 8 weeks
|
biliary history, diverticular disease
|
up to 8 weeks
|
|
Diagnostics - clinical exam
Tidsram: up to 8 weeks
|
palpable mass in the abdomen
|
up to 8 weeks
|
|
Diagnostics - endoscopy
Tidsram: up to 8 weeks
|
Colonoscopy
|
up to 8 weeks
|
|
Diagnostics - x-ray
Tidsram: up to 8 weeks
|
plain abdominal x-ray
|
up to 8 weeks
|
|
Diagnostics - computed tomography
Tidsram: up to 8 weeks
|
Abdominal computed tomography
|
up to 8 weeks
|
|
Diagnostics - specific signs
Tidsram: up to 8 weeks
|
Colonic Rigler's triad
|
up to 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Therapeutic options - operation without resection
Tidsram: up to 8 weeks
|
number of patients with cololithotomy
|
up to 8 weeks
|
|
Therapeutic options - operation with resection
Tidsram: up to 8 weeks
|
number of patients with colonic resection
|
up to 8 weeks
|
|
Therapeutic options - conservative treatment
Tidsram: up to 8 weeks
|
number of patients treated conservatively
|
up to 8 weeks
|
|
Survival
Tidsram: up to 8 weeks
|
Survival of patients according to therapeutic option
|
up to 8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Goran Augustin, M.D., Ph.D, Clinical Hospital Centre Zagreb
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 01012021
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Gallsten
-
QualiMed Innovative Medizinprodukte GmbHRekryteringBlockerad gall- och bukspottkörtelkanalSpanien, Israel, Finland, Italien, Slovenien, Tyskland
-
University of BolognaAvslutadLesion; Gastrointestinala | Lever-, gall-, bukspottkörtel- och gastrointestinala sjukdomar, nrItalien
-
Memorial Sloan Kettering Cancer CenterAvslutadBukspottskörtelcancer | Obegreppbara gall-pankreatiska maligniteterFörenta staterna
Kliniska prövningar på operation or non-operative treatment
-
University Hospital, AkershusVestre Viken Hospital Trust; Oslo University Hospital; Sykehuset Ostfold; H...Avslutad
-
Tampere University HospitalAvslutad
-
University Hospital, AkershusAsker & Baerum Hospital; Sorlandet Hospital HF; Kristiansund Hospital; Norwegian...Rekrytering
-
Assistance Publique - Hôpitaux de ParisAvslutadIdiopatisk membranös nefropatiFrankrike