Laparoscopic CholecystectomyNCT06197373
Laparoscopic Cholecystectomy After ERCP
An observational study of Laparoscopic Cholecystectomy, run by Mohamed Bakr Mohamed Ahmed.
Trial summary
Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Apr 2026
- How long will I take part?
- 21 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patient present with CBD obstruction and GB stones So Undergoing ERCP then Laparoscopic cholecystectomy
Who may be able to join
- female patient
- 18-60 years old
Who cannot join
- male patient
- extremes of age less than 18 and more than 60
Trial locations and contacts
No sites are listed yet.
Bakr contact
About this study
Official title: Outcomes of Early and Late Laparoscopic Cholecystectomy (LC) After Endoscopic Retrograde CholangioPancreatography (ERCP), Prospective Study .
Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP
Read the detailed description
Evaluation of both benefits and harms of doing laparoscopic cholecystectomy early within first 72 hours and late from the third day up to 2 months after ERCP
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Also called ERCP
Doing laparoscopic cholecystectomy after ERCP at different intervals
| Study group | Role | What they receive |
|---|---|---|
| Early laparoscopic cholecystectomy after ERCP | Evaluation of outcomes of early ( within 72 hours) laparoscopic cholecystectomy after ERCP Receives: Procedure: Laparoscopic cholecystectomy | |
| Late laparoscopic cholecystectomy after ERCP | Evaluation of outcomes of late ( form third day up to 2months ) laparoscopic cholecystectomy after ERCP Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the operation
Measuring the time of the operation
Measured: 5 hours
Bleeding during operation
Measuring amount of blood loss during operation
Measured: 5 hours
Hospital stay duration
Measuring time of hospital stay
Measured: 7 days
Rate of Conversion to open cholecystectomy
Documenting number of cases undergoing conversion from laparoscopic to open cholecystectomy
Measured: 5 hours
Secondary outcomes (1)
Total cost of the medical service in both categories
Measuring the cost of the medical service in both categories for economic preference
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Mohamed Bakr Mohamed Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Bakr Mohamed Ahmed, Assiut University
- Investigators
- Thabet, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197373
- Sponsor's protocol ID
- cholecystectomy after ERCP
- Status last verified
- Apr 2024
- First submitted
- 9 Dec 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early and Late Laparoscopic Cholecystectomy (LC) After Endoscopic Retrograde CholangioPancreatography (ERCP), Prospective Study .
- ClinicalTrials.gov ID
- NCT06197373
- Acronym / sponsor ID
- cholecystectomy after ERCP
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohamed Bakr Mohamed AhmedUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of outcomes of early and late laparoscopic cholecystectomy after ERCP
Detailed description
Evaluation of both benefits and harms of doing laparoscopic cholecystectomy early within first 72 hours and late from the third day up to 2 months after ERCP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early laparoscopic cholecystectomy after ERCP | – | Procedure: Laparoscopic cholecystectomyEvaluation of outcomes of early ( within 72 hours) laparoscopic cholecystectomy after ERCP |
| Late laparoscopic cholecystectomy after ERCP | – | Procedure: Laparoscopic cholecystectomyEvaluation of outcomes of late ( form third day up to 2months ) laparoscopic cholecystectomy after ERCP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patient present with CBD obstruction and GB stones So Undergoing ERCP then Laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- female patient
- 18-60 years old
Key exclusion criteria (2 listed)
- male patient
- extremes of age less than 18 and more than 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyAlso: ERCPDoing laparoscopic cholecystectomy after ERCP at different intervals | Procedure or surgery | Early laparoscopic cholecystectomy after ERCP, Late laparoscopic cholecystectomy after ERCP |
Primary outcome
Duration of the operation
Time frame: 5 hours
Measuring the time of the operation
Bleeding during operation
Time frame: 5 hours
Measuring amount of blood loss during operation
Hospital stay duration
Time frame: 7 days
Measuring time of hospital stay
Rate of Conversion to open cholecystectomy
Time frame: 5 hours
Documenting number of cases undergoing conversion from laparoscopic to open cholecystectomy
1 secondary outcome
Total cost of the medical service in both categories
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bakr contact
Thabet study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy, run by Mohamed Bakr Mohamed Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahran (01062837490, mbakrmahran00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the operation (time frame: 5 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.