Acute CholecystitisNCT03853408
Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital
An observational study of Acute Cholecystitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 26 Jul 2017to 29 Nov 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data were collected retrospectively from the electronic medical records data system at KAUH. We included all adult patients who presented to the Emergency Department of KAUH with an acute cholecystitis between January 2010 and April 2018
Who may be able to join
- Male and female patients who presented to the Emergency Department of KAUH with an acute cholecystitis
Who cannot join
- Patients with no acute cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia.
Read the detailed description
This study was conducted retrospectively through reviewing patients medical records
- Conditions
- Acute Cholecystitis
- Being tested
- Cholecystectomy
- Keywords
- Acute cholecystitis, Cholecystectomy, overweight, BMI, early, delayed
- Medical subject headings
- Cholecystitis, Acute, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Cholecystectomy (removal of the gallbladder) for acute cholecystitis
| Study group | Role | What they receive |
|---|---|---|
| First Admission | Cholecystectomy during first admission Receives: Procedure: Cholecystectomy | |
| Second Admission | Cholecystectomy during second admission Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of surgery
Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open
Measured: Intraoperative (during surgery) - surgery takes an hour on an average
Blood Transfusion need
- Yes
- No
Measured: Intraoperative (during surgery) - surgery takes an hour on an average
ICU admission:
- Yes
- No
Measured: Post operation "after surgery" immediately
Duration of Surgery
How many minutes did the surgery take (range)
Measured: minutes "intraoperative" (surgery takes 1 hour on an average)
Time to operation room (hours)
How many hours from admission to surgery
Measured: hours pre surgery
Length of stay after surgery
How many days did patients stay after surgery (range)
Measured: Days ( usually 2 days on an average )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start26 Jul 2017
- Primary completion14 Sep 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munirah Fetaini, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853408
- Sponsor's protocol ID
- D/39/3441
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during this study are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital
- ClinicalTrials.gov ID
- NCT03853408
- Acronym / sponsor ID
- D/39/3441
- Conditions
- Acute Cholecystitis
- Keywords
- Acute cholecystitis, Cholecystectomy, overweight, BMI, early, delayed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 25 Feb 2019 (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.
The aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia.
Detailed description
This study was conducted retrospectively through reviewing patients medical records
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Admission | – | Procedure: CholecystectomyCholecystectomy during first admission |
| Second Admission | – | Procedure: CholecystectomyCholecystectomy during second admission |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data were collected retrospectively from the electronic medical records data system at KAUH. We included all adult patients who presented to the Emergency Department of KAUH with an acute cholecystitis between January 2010 and April 2018
Key inclusion criteria (1 listed)
- Male and female patients who presented to the Emergency Department of KAUH with an acute cholecystitis
Key exclusion criteria (1 listed)
- Patients with no acute cholecystitis
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 |
|---|---|---|
| CholecystectomyCholecystectomy (removal of the gallbladder) for acute cholecystitis | Procedure or surgery | First Admission, Second Admission |
Primary outcome
Type of surgery
Time frame: Intraoperative (during surgery) - surgery takes an hour on an average
Laparoscopic cholecystectomy or Laparoscopic cholecystectomy converted to open
Blood Transfusion need
Time frame: Intraoperative (during surgery) - surgery takes an hour on an average
* Yes * No
ICU admission:
Time frame: Post operation "after surgery" immediately
* Yes * No
Duration of Surgery
Time frame: minutes "intraoperative" (surgery takes 1 hour on an average)
How many minutes did the surgery take (range)
Time to operation room (hours)
Time frame: hours pre surgery
How many hours from admission to surgery
Length of stay after surgery
Time frame: Days ( usually 2 days on an average )
How many days did patients stay after surgery (range)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during this study are available upon request
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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
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RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
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Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
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Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of surgery (time frame: Intraoperative (during surgery) - surgery takes an hour on an average). The study lists 6 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 25 Feb 2019.