One Session Vs Staged Management of Calcular Obstructive Jaundice

October 11, 2023 updated by: Alaa Mstafa Hassan Sewefy, Minia University

One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

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
      • Minya, Egypt, 61511
        • Recruiting
        • Faculty of medicine
        • Contact:
        • Contact:
          • M

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age from 18-70 year
  • combined CBD and gall stone
  • stone less than 1.5 cm
  • fit for surgery
  • no upper abdominal surgery

Exclusion Criteria:

  • age <18 and >70
  • unfit for surgery
  • stone more than 1.5 cm
  • upper abdominal surgery

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: staged managment
ERCP then interval laparoscopic cholecystectomy
Procedure: staged managment
staged management
Experimental: one session ERCP then LC
Procedure: one session ERCP then LC
one session ERCP then LC
Experimental: one session LC then ERCP
Procedure: one session LC then ERCP
one session LC then ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cost
Time Frame: 6 months
total cost in Egyptian pound
6 months
hospital stay
Time Frame: 6 months
total hospital stay in days
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 30 days
early postoperative complications
30 days

Collaborators and Investigators

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

Sponsor

Minia 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)

August 5, 2023

Primary Completion (Estimated)

February 15, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

July 30, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.23.42

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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