One Session Vs Staged Management of Calcular Obstructive... | NCT05979233

Studies
One Session Vs Staged Management of Calcular Obstructive Jaundice

NCT05979233

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Oct 13, 2023Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Calcular Obstructive Jaundice
Gall Bladder Disease

Interventions

staged managment
one session ERCP then LC
one session LC then ERCP

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2023Actual

Primary Completion Date

Feb 15, 2024Estimated

Completion Date

Feb 20, 2024Estimated

First Submitted Date

Jul 30, 2023

First Submission Date that Met QC Criteria

Jul 30, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2023

Last Update Posted Date

Oct 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Mstafa Hassan Sewefy, MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
staged managment	Active Comparator	ERCP then interval laparoscopic cholecystectomy	Procedure: staged managment
one session ERCP then LC	Experimental	one session ERCP then LC	Procedure: one session ERCP then LC
one session LC then ERCP	Experimental	one session LC then ERCP	Procedure: one session LC then ERCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
staged managment	Procedure	staged management	staged managment
one session ERCP then LC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
complications	early postoperative complications	30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine	Recruiting	Minya		61511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided