CholecystectomyAL-CODSNCT06481007
ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS)
An observational study of Cholecystectomy and Adults, run by University of Oran 1.
Trial summary
Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Adults, Gall Stone
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 2 Jul 2025
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients aged 18 years and older who undergo cholecystectomy for benign gallbladder diseases in Algeria. This includes patients who have their gallbladders removed due to conditions such as gallstones, cholecystitis, biliary dyskinesia and any other benign pathology
Who may be able to join
- Patients aged 18 years and older.
- Undergoing cholecystectomy.
- Surgery performed in public or private hospitals in Algeria.
- Surgery performed from January 1, 2025, to June 30, 2025.
Who cannot join
- Patients younger than 18 years.
- Patients refusing to participate.
- Cholecystectomy performed for Gallbladder cancer.
- Cholecystectomy performed outside the inclusion period.
- Cholecystectomies performed in conjunction with other major surgeries.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Algerian Cholecystectomy Outcomes and Determinants Study
Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. While generally considered safe, this surgery can be associated with significant morbidity and mortality, particularly in certain populations or healthcare settings. Understanding these outcomes and the factors influencing them is crucial for improving patient care and surgical practices.
In Algeria, the healthcare landscape presents unique challenges and opportunities for evaluating surgical outcomes. Limited studies have specifically focused on the morbidity and mortality associated with cholecystectomy in this context. This study aims to fill that gap by providing comprehensive data on 30-day postoperative outcomes following cholecystectomy for benign gallbladder diseases in Algeria. Such data is essential for benchmarking current practices, identifying areas for improvement, and ultimately enhancing patient safety and surgical efficacy.
Read the detailed description
This study seeks to bridge this knowledge gap by offering detailed data on 30-day postoperative outcomes after cholecystectomy for benign gallbladder diseases in Algeria. This information is crucial for benchmarking existing practices, pinpointing areas for enhancement, and ultimately improving patient safety and surgical effectiveness.
- Conditions
- Cholecystectomy, Adults, Gall Stone, Polyps, Pancreatitis Biliary, Gallbladder Dyskinesia
- Keywords
- Algeria, Cholecystectomy, mortality, morbidity, 30 days, determinants
- Medical subject headings
- Gallstones, Polyps, Biliary Dyskinesia, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy | patient opérated ( cholecystectomy) and responding to inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 30-day mortality and morbidity
Evaluation of rate of mortality and morbidity at 30 day
Measured: occuring in of before 30 day postopérative période.
factors associated with 30-day morbidity and mortality
determinants of the occurence of complications and mortality on or before 30 day in postopérative period
Measured: occuring in of before 30 day postopérative période.
Secondary outcomes (3)
estimate the incidence of incidental gallbladder cancer discovered during cholecystectomy in Algeria.
Measured: postoperative periode ( during or after surgical procedure)
estimate the incidence of bile duct injuries following cholecystectomy for benign diseases
Measured: occuring in of before 30 day postopérative periode.
assess surgical practices related to cholecystectomy in Algeria.
Measured: During surgical procedure ( Cholecystectomy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Oran 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisse Tidjane, University of Oran 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481007
- Sponsor's protocol ID
- Univ-2024-0017
- Acronym
- AL-CODS
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we are not going to share data , but the study will be published in an open acces journal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algerian Cholecystectomy Outcomes and Determinants Study
- ClinicalTrials.gov ID
- NCT06481007
- Acronym / sponsor ID
- AL-CODS / Univ-2024-0017
- Conditions
- Cholecystectomy, Adults, Gall Stone, Polyps, Pancreatitis Biliary, Gallbladder Dyskinesia
- Keywords
- Algeria, Cholecystectomy, mortality, morbidity, 30 days, determinants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Oran 1University, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 1 Jul 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.
Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. While generally considered safe, this surgery can be associated with significant morbidity and mortality, particularly in certain populations or healthcare settings. Understanding these outcomes and the factors influencing them is crucial for improving patient care and surgical practices.
In Algeria, the healthcare landscape presents unique challenges and opportunities for evaluating surgical outcomes. Limited studies have specifically focused on the morbidity and mortality associated with cholecystectomy in this context. This study aims to fill that gap by providing comprehensive data on 30-day postoperative outcomes following cholecystectomy for benign gallbladder diseases in Algeria. Such data is essential for benchmarking current practices, identifying areas for improvement, and ultimately enhancing patient safety and surgical efficacy.
Detailed description
This study seeks to bridge this knowledge gap by offering detailed data on 30-day postoperative outcomes after cholecystectomy for benign gallbladder diseases in Algeria. This information is crucial for benchmarking existing practices, pinpointing areas for enhancement, and ultimately improving patient safety and surgical effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy | – | –patient opérated ( cholecystectomy) and responding to inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients aged 18 years and older who undergo cholecystectomy for benign gallbladder diseases in Algeria. This includes patients who have their gallbladders removed due to conditions such as gallstones, cholecystitis, biliary dyskinesia and any other benign pathology
Key inclusion criteria (4 listed)
- Patients aged 18 years and older.
- Undergoing cholecystectomy.
- Surgery performed in public or private hospitals in Algeria.
- Surgery performed from January 1, 2025, to June 30, 2025.
Key exclusion criteria (5 listed)
- Patients younger than 18 years.
- Patients refusing to participate.
- Cholecystectomy performed for Gallbladder cancer.
- Cholecystectomy performed outside the inclusion period.
- Cholecystectomies performed in conjunction with other major surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the 30-day mortality and morbidity
Time frame: occuring in of before 30 day postopérative période.
Evaluation of rate of mortality and morbidity at 30 day
factors associated with 30-day morbidity and mortality
Time frame: occuring in of before 30 day postopérative période.
determinants of the occurence of complications and mortality on or before 30 day in postopérative period
3 secondary outcomes
estimate the incidence of incidental gallbladder cancer discovered during cholecystectomy in Algeria.
Time frame: postoperative periode ( during or after surgical procedure)
estimate the incidence of bile duct injuries following cholecystectomy for benign diseases
Time frame: occuring in of before 30 day postopérative periode.
assess surgical practices related to cholecystectomy in Algeria.
Time frame: During surgical procedure ( Cholecystectomy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No. we are not going to share data , but the study will be published in an open acces journal.
Related trials for Cholecystectomy
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingObservational study
Incidental Gallbladder Carcinoma :Incidence and Clinical Significance in Specimens From Routine Cholecystectomies in Sohag Locality
Gall Bladder Carcinoma
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy and Adults, run by University of Oran 1.
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 4 inclusion and 5 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 1 Jul 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 Anisse Tidjane, Pr (00213 561806152, tidjane.anisse@univ-oran1.dz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the 30-day mortality and morbidity (time frame: occuring in of before 30 day postopérative période.). The study lists 2 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 1 Jul 2024.