NCT04475796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 14, 2020

Last Update Submit

July 14, 2020

Conditions

Choledocholithiasis With Cholecystitis

Keywords

CholedocholithiasisEarlyDelayedLaparoscopic cholecystectomyERCPNassar scale

Outcome Measures

Primary Outcomes (1)

  • operative time

    the time to perform laparoscopic cholecystectomy from the time of incision to the last suture

    one day

Secondary Outcomes (1)

  • intraoperative difficulty and complications

    one day

Study Arms (2)

Early group

ACTIVE COMPARATOR
Procedure: Laparoscopic cholecystectomy

Delayed group

ACTIVE COMPARATOR
Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy performed after ERCP

Delayed groupEarly group

Eligibility Criteria

Age16 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Ahmed Aouf, Dr.

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

February 1, 2019

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

EG(1)