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Completed

NCT Number: NCT03888976

Cholecystoduodenal Fistula With and Without Gallstone Ileus

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

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Key information

Conditions

Gallbladder Diseases Biliary Tract Diseases Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

15 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Metropolitano

San Nicolás de los Garza, Nuevo León, 66400, Mexico

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cholecystoduodenal fistula

Exclusion criteria

  • Patients with cholecystocolonic fistula or cholecystogastric fistula

Treatment and study plan

Cholecystectomy

Procedure

Cholecystectomy with repair of duodenal wall.

Primary outcomes

  1. Median Age

    Time frame: Feb 01- 2020

    Age in years

  2. Median value of white blood count

    Time frame: Feb 01-2020

    It will presented in cells/L

  3. Type of surgery performed

    Time frame: Feb 01-2020

    It will described the type of procedure, either conventional or laparoscopic

  4. Surgical complications

    Time frame: Feb 01-2020

    Morbidity will be described as Yes or No

  5. Recovering time

    Time frame: Feb 01-2020

    The median time in days, after the procedure and full recovery of the patients.

Sponsors and collaborators

Lead sponsor

Tecnologico de Monterrey

Other

Registry information

Official study title

Cholecystoduodenal Fistula With and Without Gallstone Ileus: A Case Series

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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