Early Versus Delayed Laparoscopic Cholecystectomy Followi... | NCT04475796

Studies
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

NCT04475796

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Jul 17, 2020Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Choledocholithiasis With Cholecystitis

Interventions

Laparoscopic cholecystectomy

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Jul 14, 2020

First Submission Date that Met QC Criteria

Jul 14, 2020

First Posted Date

Jul 17, 2020Actual

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

Jul 14, 2020

Last Update Posted Date

Jul 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early group	Active Comparator		Procedure: Laparoscopic cholecystectomy
Delayed group	Active Comparator		Procedure: Laparoscopic cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic cholecystectomy	Procedure	Laparoscopic cholecystectomy performed after ERCP	Delayed group Early group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
operative time	the time to perform laparoscopic cholecystectomy from the time of incision to the last suture	one day

Secondary Outcomes

Measure	Description	Time Frame
intraoperative difficulty and complications	the difficulties that face the surgeon during the surgery and the early complications that result	one day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP

Exclusion Criteria:

advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

adult

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Aouf, Dr.	Kafrelsheikh University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh University		Kafr ash Shaykh	Kafr el-Sheikh Governorate	33516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D042883	Choledocholithiasis

Ancestor Terms

ID	Term
D003137	Common Bile Duct Diseases
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic

Ancestor Terms

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided