Acute CholecystitisRCTNCT03999645
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?
A study testing Early laparoscopic cholecystectomy and Late laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC). Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Early laparoscopic cholecystectomy and Late laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 30 Apr 2019
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with AC within seven days from symptom onset
- American Society of Anesthesiologist (ASA) physical status ≤ II
- Age from 21 to 60 years
Who cannot join
- Patients with ASA physical status > II
- Age < 21 years or > 60 years
- Child classification B or C
- Choledocholithiasis
- Acute pancreatitis
- Severe sepsis
- Gallbladder perforation
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).
Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.
Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.
- Conditions
- Acute Cholecystitis
- Being tested
- Early laparoscopic cholecystectomy, Late laparoscopic cholecystectomy
- Keywords
- Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Acute, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early laparoscopic cholecystectomyProcedure or surgery
within 72h from symptom onset
Late laparoscopic cholecystectomyProcedure or surgery
after 72h up to seven days from symptom onset
| Study group | Role | What they receive |
|---|---|---|
| Group E: Early LC (n=60) | Active comparator | Early laparoscopic cholecystectomy (within 72h from symptom onset) Receives: Procedure: Early laparoscopic cholecystectomy |
| Group L: Late LC (n=60) | Active comparator | Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset) Receives: Procedure: Late laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants and Rate of Post-operative complications
Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate
Measured: 30 days post-operatively
Secondary outcomes (4)
Mean and Standard deviation of Operative duration (hours) (mean±SD)
Mean and Standard deviation of Operative duration (hours)
Measured: from surgical incision till suture closure
Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)
Mean and Standard deviation of Intra-operative blood loss (ml)
Measured: from surgical incision till suture closure
Number of participants and Rate of Conversion to open cholecystectomy
Number of participants and Rate of Conversion to open cholecystectomy
Measured: from the start till the end of surgical procedure
Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
Mean and Standard deviation of Length of hospital stay (days)
Measured: from hospital admission till home discharge within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Sep 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohamed M Abdalgaleil, MD, Principal investigator, Damanhour Teaching HospitalAhmed M Shaat, MD, Principal investigator, Damanhour Teaching HospitalOsama S Elbalky, MD, Study director, Damanhour Teaching HospitalMamdouh M Ibrahim, MD, Study chair, Damanhour Teaching HospitalMohamed S Elnagar, MD, Study chair, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999645
- Sponsor's protocol ID
- DTH:19002
- Acronym
- RCT
- Status last verified
- Jun 2019
- First submitted
- 23 Jun 2019
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03999645
- Acronym / sponsor ID
- RCT / DTH:19002
- Conditions
- Acute Cholecystitis
- Keywords
- Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 27 Jun 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.
Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).
Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.
Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E: Early LC (n=60) | Active comparator | Procedure: Early laparoscopic cholecystectomyEarly laparoscopic cholecystectomy (within 72h from symptom onset) |
| Group L: Late LC (n=60) | Active comparator | Procedure: Late laparoscopic cholecystectomyLate laparoscopic cholecystectomy (after 72h up to seven days from symptom onset) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with AC within seven days from symptom onset
- American Society of Anesthesiologist (ASA) physical status ≤ II
- Age from 21 to 60 years
Key exclusion criteria (8 listed)
- Patients with ASA physical status > II
- Age < 21 years or > 60 years
- Child classification B or C
- Choledocholithiasis
- Acute pancreatitis
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 |
|---|---|---|
| Early laparoscopic cholecystectomywithin 72h from symptom onset | Procedure or surgery | Group E: Early LC (n=60) |
| Late laparoscopic cholecystectomyafter 72h up to seven days from symptom onset | Procedure or surgery | Group L: Late LC (n=60) |
Primary outcome
Number of participants and Rate of Post-operative complications
Time frame: 30 days post-operatively
Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate
4 secondary outcomes
Mean and Standard deviation of Operative duration (hours) (mean±SD)
Time frame: from surgical incision till suture closure
Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)
Time frame: from surgical incision till suture closure
Number of participants and Rate of Conversion to open cholecystectomy
Time frame: from the start till the end of surgical procedure
Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
Time frame: from hospital admission till home discharge within 30 days
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 27 Jun 2019.
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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.
Mohamed M Abdalgaleil, MD principal investigator
Damanhour Teaching Hospital
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
Osama S Elbalky, MD study director
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early laparoscopic cholecystectomy and Late laparoscopic cholecystectomy in people with Acute Cholecystitis, run by Damanhour Teaching Hospital at 1 site in Egypt.
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 3 inclusion and 8 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 27 Jun 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 Egypt. 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?
Number of participants and Rate of Post-operative complications (time frame: 30 days post-operatively). 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 27 Jun 2019.