- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690101
Treatment of Choledocolithiasis by Laparoscopic Exploration
December 27, 2020 updated by: Israel De Alba Cruz, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Treatment of Choledocolithiasis by Laparoscopic Exploration of The Bile Tract After Failed Endoscopic Cholangiopancreatography
There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct.
A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
this study was revision of clinical files.
Study Type
Observational
Enrollment (Actual)
75
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service of the General Ignacio Zaragoza
Description
Inclusion Criteria:
- Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service
Exclusion Criteria:
- Less than 18 year old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TREATMENT OF CHOLEDOCOLITHIASIS
Time Frame: 2009-2018
|
TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY
|
2009-2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2009
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
December 22, 2020
First Submitted That Met QC Criteria
December 27, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 27, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDC001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.