Cholecystitis, AcuteNCT05502744
Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
A study testing Laparoscopic cholecystectomy in people with Cholecystitis, Acute, run by Assiut University.
Trial summary
The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystitis, Acute
- 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2022to 14 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age less than 70 years.
- fit for surgery.
Who cannot join
- patients with co-existent common bile duct stones based on imaging and biochemical criteria.
- Patients with Pancreatitis .
- Patients with previous upper abdominal surgery.
- Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)
About this study
Official title: Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study
The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.
Read the detailed description
Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.
- Conditions
- Cholecystitis, Acute
- 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
Also called Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopy
Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy | Experimental | A Prospective Randomized Comparative Study. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
Collect results and see.
Measured: Intraoperative time
Secondary outcomes (1)
Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
Collect results and see.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start14 Aug 2022 (estimated)
- Primary completion14 Sep 2022 (estimated)
- Study completion14 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Ezz Rabie, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502744
- Sponsor's protocol ID
- Still not known
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05502744
- Acronym / sponsor ID
- Still not known
- Conditions
- Cholecystitis, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Aug 2022 (estimated)
- Primary completion
- 14 Sep 2022 (estimated)
- Study completion
- 14 Aug 2023 (estimated)
- First posted
- 16 Aug 2022 (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 study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.
Detailed description
Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy | Experimental | Procedure: Laparoscopic cholecystectomyA Prospective Randomized Comparative Study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age less than 70 years.
- fit for surgery.
Key exclusion criteria (4 listed)
- patients with co-existent common bile duct stones based on imaging and biochemical criteria.
- Patients with Pancreatitis .
- Patients with previous upper abdominal surgery.
- Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.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 cholecystectomyAlso: Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopyLaparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective. | Procedure or surgery | Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy |
Primary outcome
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
Time frame: Intraoperative time
Collect results and see.
1 secondary outcome
Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
Time frame: 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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 Cholecystitis, Acute, 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 2 inclusion and 4 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 16 Aug 2022. 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?
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy. (time frame: Intraoperative time). 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 16 Aug 2022.