NCT06197373

Brief Summary

Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

December 9, 2023

Last Update Submit

April 4, 2024

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (4)

  • Duration of the operation

    Measuring the time of the operation

    5 hours

  • Bleeding during operation

    Measuring amount of blood loss during operation

    5 hours

  • Hospital stay duration

    Measuring time of hospital stay

    7 days

  • Rate of Conversion to open cholecystectomy

    Documenting number of cases undergoing conversion from laparoscopic to open cholecystectomy

    5 hours

Secondary Outcomes (1)

  • Total cost of the medical service in both categories

    2 months

Study Arms (2)

Early laparoscopic cholecystectomy after ERCP

Evaluation of outcomes of early ( within 72 hours) laparoscopic cholecystectomy after ERCP

Procedure: Laparoscopic cholecystectomy

Late laparoscopic cholecystectomy after ERCP

Evaluation of outcomes of late ( form third day up to 2months ) laparoscopic cholecystectomy after ERCP

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Doing laparoscopic cholecystectomy after ERCP at different intervals

Also known as: ERCP
Early laparoscopic cholecystectomy after ERCPLate laparoscopic cholecystectomy after ERCP

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patient present with CBD obstruction and GB stones So Undergoing ERCP then Laparoscopic cholecystectomy

You may qualify if:

  • female patient
  • years old

You may not qualify if:

  • male patient
  • extremes of age less than 18 and more than 60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cholecystectomy, LaparoscopicCholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical ProceduresCholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemDiagnostic Techniques, Surgical

Study Officials

  • Thabet

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mahran

CONTACT

01062837490mbakrmahran00@gmail.com

Bakr

CONTACT

01092868621

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
21 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of general surgery at assuit university

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 9, 2024

Study Start

August 1, 2024

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

April 8, 2024

Record last verified: 2024-04