Cholecystectomy in Patients With Silent Common Bile Duct Stones

April 19, 2024 updated by: Ahmad Ali Maklad, Suez University
Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Qinā, Egypt
        • Qeft Teatching Hospital
      • Qinā, Egypt
        • Qena Faculty of Medicine
      • Suez, Egypt, 43221
        • Suez Faculty of Medicine

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients presented by chronic calcular cholecystitis and during investigation they discovers that they have silent common bile duct stones

Description

Inclusion Criteria:

  • Patients with asymptomatic common bile duct stones.
  • Patients with normal bilirubin levels.
  • Patients with normal alkaline phosphates level.

Exclusion Criteria:

  • Patients with history of jaundice.
  • Patients with abnormal liver functions.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lap chole
patients presented by cholecystitis with silent CBD stones
Procedure: laparoscopic cholecystectomy
slandered laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients developed jaundice post cholecystectomy
Time Frame: 6 months
patients presented by symptomatic gall bladder stones and during investigation discovered that they have silent common bile duct stone so we assess the safety of performing cholecystectomy without developing jaundice
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
developing of jaundice
Time Frame: 6 months
the number of patients suffering from jaundice after cholecystectomy and need for intervention as ERCP
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez University

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)

February 15, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUEZ MED - IRB Approval NO: 6

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.

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