Acute Calculous CholecystitisNCT05484232
Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
A study testing Laparoscopic Cholecystectomy in people with Acute Calculous Cholecystitis, run by Sohag University at 1 site in Egypt.
Trial summary
Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acute Calculous Cholecystitis
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Feb 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient presented by Acute cholecystitis fit for lap cholecystectomy .
Who cannot join
- Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones
Trial locations and contacts
1 site in 1 country.
Ahmed e Ahmed, professor contact
About this study
Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks.
Elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment.
Early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.
- Conditions
- Acute Calculous 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
Early laparoscopic cholecystectomy in patients with acute calcular cholecystitis
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of surgery ,
compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Measured: Intraoperative
percentage of complications
compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Measured: 6 months
morbidity
compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Measured: 6 months
mortality
compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
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 posted2 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Calculous CholecystitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Ali Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484232
- Sponsor's protocol ID
- Soh-Med-22-07-10
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gul R, Dar RA, Sheikh RA, Salroo NA, Matoo AR, Wani SH. Comparison of early and delayed laparoscopic cholecystectomy for acute cholecystitis: experience from a single center. N Am J Med Sci. 2013 Jul;5(7):414-8. doi: 10.4103/1947-2714.115783.
PubMed 24020050Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.
PubMed 24444271Cao AM, Eslick GD, Cox MR. Early Cholecystectomy Is Superior to Delayed Cholecystectomy for Acute Cholecystitis: a Meta-analysis. J Gastrointest Surg. 2015 May;19(5):848-57. doi: 10.1007/s11605-015-2747-x. Epub 2015 Mar 7.
PubMed 25749854Minutolo V, Licciardello A, Arena M, Nicosia A, Di Stefano B, Cali G, Arena G. Laparoscopic cholecystectomy in the treatment of acute cholecystitis: comparison of outcomes and costs between early and delayed cholecystectomy. Eur Rev Med Pharmacol Sci. 2014 Dec;18(2 Suppl):40-6.
PubMed 25535191
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT05484232
- Acronym / sponsor ID
- Soh-Med-22-07-10
- Conditions
- Acute Calculous Cholecystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 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.
Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks.
Elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment.
Early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient presented by Acute cholecystitis fit for lap cholecystectomy .
Key exclusion criteria (1 listed)
- Patients unfit for laparoscopic surgery such as patients with significant medical illness (ASAgrade more 3), pancreatitis and common bile duct stones
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 CholecystectomyEarly laparoscopic cholecystectomy in patients with acute calcular cholecystitis | Procedure or surgery | – |
Primary outcome
duration of surgery ,
Time frame: Intraoperative
compare between duration of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
percentage of complications
Time frame: 6 months
compare between percentage of complications of surgery between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
morbidity
Time frame: 6 months
compare morbidity between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
mortality
Time frame: 6 months
compare mortality between traditional elective laparoscopic cholecystectomy and early laparoscopic cholecystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 24020050Gul R, Dar RA, Sheikh RA, Salroo NA, Matoo AR, Wani SH. Comparison of early and delayed laparoscopic cholecystectomy for acute cholecystitis: experience from a single center. N Am J Med Sci. 2013 Jul;5(7):414-8. doi: 10.4103/1947-2714.115783.
- Background: PubMed 24444271Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.
- Background: PubMed 25749854Cao AM, Eslick GD, Cox MR. Early Cholecystectomy Is Superior to Delayed Cholecystectomy for Acute Cholecystitis: a Meta-analysis. J Gastrointest Surg. 2015 May;19(5):848-57. doi: 10.1007/s11605-015-2747-x. Epub 2015 Mar 7.
- Background: PubMed 25535191Minutolo V, Licciardello A, Arena M, Nicosia A, Di Stefano B, Cali G, Arena G. Laparoscopic cholecystectomy in the treatment of acute cholecystitis: comparison of outcomes and costs between early and delayed cholecystectomy. Eur Rev Med Pharmacol Sci. 2014 Dec;18(2 Suppl):40-6.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Calculous Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
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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
Recruiting
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.
Ahmed e Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Cholecystectomy in people with Acute Calculous Cholecystitis, run by Sohag 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sherif A Ahmed, resident (01094995035, shreif011109@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of surgery , (time frame: Intraoperative). The study lists 4 primary outcomes in all. 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 NCT05484232, which also lists 4 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 2 Aug 2022.