NCT03888976

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

25 days

First QC Date

March 20, 2019

Last Update Submit

March 21, 2019

Conditions

Gallbladder Diseases

Keywords

Cholecystoduodenal fistulaGallbladder

Outcome Measures

Primary Outcomes (5)

  • Median Age

    Age in years

    Feb 01- 2020

  • Median value of white blood count

    It will presented in cells/L

    Feb 01-2020

  • Type of surgery performed

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

    Feb 01-2020

  • Surgical complications

    Morbidity will be described as Yes or No

    Feb 01-2020

  • Recovering time

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

    Feb 01-2020

Interventions

CholecystectomyPROCEDURE

Cholecystectomy with repair of duodenal wall.

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent surgical resection of cholecystoduodenal fistula

You may qualify if:

  • Patients with cholecystoduodenal fistula

You may not qualify if:

  • Patients with cholecystocolonic fistula or cholecystogastric fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Metropolitano

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

Location

MeSH Terms

Conditions

Gallbladder DiseasesIntestinal Fistula

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesDigestive System FistulaIntestinal DiseasesGastrointestinal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 25, 2019

Study Start

February 1, 2019

Primary Completion

February 26, 2019

Study Completion

March 3, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

not apply

Locations

ME(1)