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RecruitingNCT05979233Updated Oct 13, 2023

One Session Vs Staged Management of Calcular Obstructive Jaundice

An interventional study of staged managment and one session ERCP then LC in Calcular Obstructive Jaundice and Gall Bladder Disease, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Calcular Obstructive Jaundice
  • Gall Bladder Disease
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • age \<18 and >70
  • unfit for surgery
  • stone more than 1.5 cm
  • upper abdominal surgery
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    staged managment

    ERCP then interval laparoscopic cholecystectomy

    Procedure: staged managment

  • Experimental
    one session ERCP then LC

    one session ERCP then LC

    Procedure: one session ERCP then LC

  • Experimental
    one session LC then ERCP

    one session LC then ERCP

    Procedure: one session LC then ERCP

Interventions

  • Procedurestaged managment

    staged management

  • Procedureone session ERCP then LC

    one session ERCP then LC

  • Procedureone session LC then ERCP

    one session LC then ERCP

05

What researchers measure

Primary outcomes

  1. total cost

    total cost in Egyptian pound

    Time frame: 6 months

  2. hospital stay

    total hospital stay in days

    Time frame: 6 months

Secondary outcomes

  1. complications

    early postoperative complications

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
  • Faculty of medicine
    Minya, 61511, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT05979233
Lead sponsor
Minia University
Responsible party
Alaa Mstafa Hassan Sewefy (MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia University) — Principal investigator
First posted
Aug 7, 2023
Start date
Aug 5, 2023
Primary completion
Feb 15, 2024 (estimated)
Completion
Feb 20, 2024 (estimated)
Last update
Oct 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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