One Session Vs Staged Management of Calcular Obstructive Jaundice

NCT ID: NCT05979233

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-05

Study Completion Date

2024-02-20

Brief Summary

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

Detailed Description

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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

Conditions

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Calcular Obstructive Jaundice Gall Bladder Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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staged managment

ERCP then interval laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

staged managment

Intervention Type PROCEDURE

staged management

one session ERCP then LC

one session ERCP then LC

Group Type EXPERIMENTAL

one session ERCP then LC

Intervention Type PROCEDURE

one session ERCP then LC

one session LC then ERCP

one session LC then ERCP

Group Type EXPERIMENTAL

one session LC then ERCP

Intervention Type PROCEDURE

one session LC then ERCP

Interventions

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staged managment

staged management

Intervention Type PROCEDURE

one session ERCP then LC

one session ERCP then LC

Intervention Type PROCEDURE

one session LC then ERCP

one session LC then ERCP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Alaa M Sewefy, MD

Role: primary

+201006448805

M

Role: backup

Other Identifiers

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fac.med.23.42

Identifier Type: -

Identifier Source: org_study_id

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