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NCT03888976 Clinical Trial

Cholecystoduodenal Fistula With and Without Gallstone Ileus

Gallbladder Diseases Clinical Trial

Official title:
Cholecystoduodenal Fistula With and Without Gallstone Ileus: A Case Series

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03888976
Other study ID # CDF031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date March 3, 2019

Study information
Verified date March 2019
Source Tecnologico de Monterrey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observative and descriptive study of 10 patients, which were diagnosed with a Cholecystoduodenal fistula, All electronic medical records were retrospectively reviewed.

Description:

A cholecystoenteric fistula is an uncommon complication of gallstone disease, although most studies in the English literature concern biliary-enteric fistulas. The aim of this study was to present a case series of patients with a cholecystoduodenal fistula (CDF), with or without gallstone ileus, along with the surgical outcomes.

From 2015 to 2018, 3245 consecutive patients underwent cholecystectomy for gallbladder disease at our institution, of whom 10 were diagnosed with a CDF. All electronic medical records were retrospectively reviewed.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 3, 2019
Est. primary completion date February 26, 2019
Accepts healthy volunteers
Gender All
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients with cholecystoduodenal fistula

Exclusion Criteria:

- Patients with cholecystocolonic fistula or cholecystogastric fistula

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cholecystectomy
Cholecystectomy with repair of duodenal wall.

Locations
Country Name City State
Mexico Hospital Metropolitano San Nicolás De Los Garza Nuevo Leon

Sponsors (1)
Lead Sponsor Collaborator
Tecnologico de Monterrey

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Median Age Age in years Feb 01- 2020
Primary Median value of white blood count It will presented in cells/L Feb 01-2020
Primary Type of surgery performed It will described the type of procedure, either conventional or laparoscopic Feb 01-2020
Primary Surgical complications Morbidity will be described as Yes or No Feb 01-2020
Primary Recovering time The median time in days, after the procedure and full recovery of the patients. Feb 01-2020
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