Acute CholecystitisACCNCT04405713
Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis
A study testing from the onset of symptoms within the first 3 days, : from the onset of symptoms within the 4-7 days and from the onset of symptoms beyond 7 days in people with Acute Cholecystitis, run by Mansoura University at 1 site in Egypt.
Trial summary
The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- from the onset of symptoms within the first 3 days, : from the onset of symptoms within the 4-7 days and from the onset of symptoms beyond 7 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 25 Mar 2020
- 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
- ACC patients who underwent early LC
Who cannot join
- Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)
The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy
Read the detailed description
This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.
- Conditions
- Acute Cholecystitis
- Being tested
- from the onset of symptoms within the first 3 days, : from the onset of symptoms within the 4-7 days, from the onset of symptoms beyond 7 days
- Keywords
- Early laparoscopic cholecystectomy, postcholecystectomy bile injury, delay 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.
from the onset of symptoms within the first 3 daysProcedure or surgery
Also called group 1
ELC within 3 days of onset of ACC
: from the onset of symptoms within the 4-7 daysProcedure or surgery
Also called Group II
ELC 4-7days of onset of ACC
from the onset of symptoms beyond 7 daysProcedure or surgery
Also called Group III
ELC after 7days of onset of ACC
| Study group | Role | What they receive |
|---|---|---|
| from the onset of symptoms within the first 3 days (group 1) | Active comparator | ELC for ACC from the onset of symptoms within the first 3 days (group 1) Receives: Procedure: from the onset of symptoms within the first 3 days |
| from the onset of symptoms within the 4-7 days | Active comparator | ELC for ACC from the onset of symptoms within the4-7 days (group II) Receives: Procedure: : from the onset of symptoms within the 4-7 days |
| from the onset of symptoms beyond 7 days | Active comparator | ELC for ACC from the onset of symptoms beyond 7 days (group III) Receives: Procedure: from the onset of symptoms beyond 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative morbidity
the incidence of postoperative morbidity during the 30th day of postoperative procedure
Measured: 30 DAYS
Secondary outcomes (3)
conversion rate
conversion rate to open cholecystectomy
Measured: INTRAOPERATIVE
blood loss
blood loss
Measured: intraoperative
hospital stay
overall hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Apr 2018
- Primary completion1 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman E Nakeeb, Principal investigator, Mansoura University, Gastrointestinal Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405713
- Sponsor's protocol ID
- early LC for ACC
- Acronym
- ACC
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: plan to make individual participant data (
Publications
El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2):e2020.00015. doi: 10.4293/JSLS.2020.00015.
PubMed 32425482Mora-Guzman I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2020 Aug;24(8):1827-1832. doi: 10.1007/s11605-019-04335-5. Epub 2019 Aug 6.
PubMed 31388885Brunee L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: 10.1080/00015458.2018.1529344. Epub 2018 Oct 25.
PubMed 30354853Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-0631-8.
PubMed 28569137Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. doi: 10.1007/s13304-016-0409-5. Epub 2016 Oct 26.
PubMed 27785732Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Oct;17(10):857-62. doi: 10.1111/hpb.12449. Epub 2015 Jul 27.
PubMed 26218858
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)
- ClinicalTrials.gov ID
- NCT04405713
- Acronym / sponsor ID
- ACC / early LC for ACC
- Conditions
- Acute Cholecystitis
- Keywords
- Early laparoscopic cholecystectomy, postcholecystectomy bile injury, delay laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 28 May 2020 (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 ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy
Detailed description
This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
| Arm | Type | Receives |
|---|---|---|
| from the onset of symptoms within the first 3 days (group 1) | Active comparator | Procedure: from the onset of symptoms within the first 3 daysELC for ACC from the onset of symptoms within the first 3 days (group 1) |
| from the onset of symptoms within the 4-7 days | Active comparator | Procedure: : from the onset of symptoms within the 4-7 daysELC for ACC from the onset of symptoms within the4-7 days (group II) |
| from the onset of symptoms beyond 7 days | Active comparator | Procedure: from the onset of symptoms beyond 7 daysELC for ACC from the onset of symptoms beyond 7 days (group III) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ACC patients who underwent early LC
Key exclusion criteria (1 listed)
- Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
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 |
|---|---|---|
| from the onset of symptoms within the first 3 daysAlso: group 1ELC within 3 days of onset of ACC | Procedure or surgery | from the onset of symptoms within the first 3 days (group 1) |
| : from the onset of symptoms within the 4-7 daysAlso: Group IIELC 4-7days of onset of ACC | Procedure or surgery | from the onset of symptoms within the 4-7 days |
| from the onset of symptoms beyond 7 daysAlso: Group IIIELC after 7days of onset of ACC | Procedure or surgery | from the onset of symptoms beyond 7 days |
Primary outcome
the incidence of postoperative morbidity
Time frame: 30 DAYS
the incidence of postoperative morbidity during the 30th day of postoperative procedure
3 secondary outcomes
conversion rate
Time frame: INTRAOPERATIVE
blood loss
Time frame: intraoperative
hospital stay
Time frame: 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 28 May 2020.
- Results publication: PubMed 32425482El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2):e2020.00015. doi: 10.4293/JSLS.2020.00015.
- Results publication: PubMed 31388885Mora-Guzman I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2020 Aug;24(8):1827-1832. doi: 10.1007/s11605-019-04335-5. Epub 2019 Aug 6.
- Results publication: PubMed 30354853Brunee L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: 10.1080/00015458.2018.1529344. Epub 2018 Oct 25.
- Results publication: PubMed 28569137Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-0631-8.
- Results publication: PubMed 27785732Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. doi: 10.1007/s13304-016-0409-5. Epub 2016 Oct 26.
- Results publication: PubMed 26218858Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Oct;17(10):857-62. doi: 10.1111/hpb.12449. Epub 2015 Jul 27.
- Mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. plan to make individual participant data (
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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.
Ayman E Nakeeb principal investigator
Mansoura University, Gastrointestinal Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing from the onset of symptoms within the first 3 days, : from the onset of symptoms within the 4-7 days and from the onset of symptoms beyond 7 days in people with Acute Cholecystitis, run by Mansoura University 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 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 28 May 2020. 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?
the incidence of postoperative morbidity (time frame: 30 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405713, which also lists 6 linked publications.
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 28 May 2020.