Back to resultsOne Session Vs Staged Management of Calcular Obstructive Jaundice
Primary Purpose
Calcular Obstructive Jaundice, Gall Bladder Disease
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
staged managment
one session ERCP then LC
one session LC then ERCP
Sponsored by
About this trial
This is an interventional treatment trial for Calcular Obstructive Jaundice
Eligibility Criteria
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
Sites / Locations
- Faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
staged managment
one session ERCP then LC
one session LC then ERCP
Arm Description
ERCP then interval laparoscopic cholecystectomy
one session ERCP then LC
one session LC then ERCP
Outcomes
Primary Outcome Measures
total cost
total cost in Egyptian pound
hospital stay
total hospital stay in days
Secondary Outcome Measures
complications
early postoperative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979233
Brief Title
One Session Vs Staged Management of Calcular Obstructive Jaundice
Official Title
One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcular Obstructive Jaundice, Gall Bladder Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
staged managment
Arm Type
Active Comparator
Arm Description
ERCP then interval laparoscopic cholecystectomy
Arm Title
one session ERCP then LC
Arm Type
Experimental
Arm Description
one session ERCP then LC
Arm Title
one session LC then ERCP
Arm Type
Experimental
Arm Description
one session LC then ERCP
Intervention Type
Procedure
Intervention Name(s)
staged managment
Intervention Description
staged management
Intervention Type
Procedure
Intervention Name(s)
one session ERCP then LC
Intervention Description
one session ERCP then LC
Intervention Type
Procedure
Intervention Name(s)
one session LC then ERCP
Intervention Description
one session LC then ERCP
Primary Outcome Measure Information:
Title
total cost
Description
total cost in Egyptian pound
Time Frame
6 months
Title
hospital stay
Description
total hospital stay in days
Time Frame
6 months
Secondary Outcome Measure Information:
Title
complications
Description
early postoperative complications
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy, MD
Phone
+201006448805
Email
sewafy@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
M
12. IPD Sharing Statement
Learn more about this trial
One Session Vs Staged Management of Calcular Obstructive Jaundice
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