Acute CholecystitisNCT06459323
the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!
A study testing Laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Assiut University.
Trial summary
Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute cholecystitis within and after 72 hours.
- Patients over 18 years.
- Patients with no common bile duct stones based on imaging and biochemical criteria
- Fit for surgery.
Who cannot join
- Patients not fit for surgery
- Patients with Pancreatitis.
- Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)
About this study
Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.
Read the detailed description
Laparoscopic cholecystectomy (LC) is the mainstay treatment of acute cholecystitis. However, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of AC progresses. New Guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. Hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients Studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the Calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for LC performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. After 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.Studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. However, other studies did not report any difference in operation times between both groups.
- Conditions
- Acute Cholecystitis
- Being tested
- Laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy within first 72hours | Experimental | Not described Receives: Procedure: Laparoscopic cholecystectomy |
| Laparoscopic cholecystectomy beyond first 72hours | Experimental | Not described Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile duct injury , intraoperative bleeding and operative time
Evaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Refaat Mansour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459323
- Sponsor's protocol ID
- Cholecystectomy timing
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!
- ClinicalTrials.gov ID
- NCT06459323
- Acronym / sponsor ID
- Cholecystectomy timing
- Conditions
- Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 14 Jun 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.
Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.
Detailed description
Laparoscopic cholecystectomy (LC) is the mainstay treatment of acute cholecystitis. However, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of AC progresses. New Guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. Hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients Studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the Calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for LC performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. After 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.Studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. However, other studies did not report any difference in operation times between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy within first 72hours | Experimental | Procedure: Laparoscopic cholecystectomy |
| Laparoscopic cholecystectomy beyond first 72hours | Experimental | Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute cholecystitis within and after 72 hours.
- Patients over 18 years.
- Patients with no common bile duct stones based on imaging and biochemical criteria
- Fit for surgery.
Key exclusion criteria (3 listed)
- Patients not fit for surgery
- Patients with Pancreatitis.
- Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)
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 cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy beyond first 72hours, Laparoscopic cholecystectomy within first 72hours |
Primary outcome
Bile duct injury , intraoperative bleeding and operative time
Time frame: One week
Evaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Navez, B., Ungureanu, F., Michiels, M. et al. Surgical management of acute cholecystitis: results of a 2-year prospective multicenter survey in Belgium. Surg Endosc 26, 2436-2445 (2012).Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Assiut University.
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 3 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 14 Jun 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?
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?
Bile duct injury , intraoperative bleeding and operative time (time frame: One week). 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 14 Jun 2024.