Acute Calculous CholecystitisNCT03477253
Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days
A study testing Laparoscopic cholecystectomy in people with Acute Calculous Cholecystitis, run by Assiut University at 1 site in Egypt.
Trial summary
This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Calculous 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
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
- Initial surgical management planned for immediate laparoscopic cholecystectomy.
- Patients who are fit for laparoscopy and general anesthesia.
- Patient who agree to provide short term outcome data and agree to provide contact information.
Who cannot join
- Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
- Patients with other associated abdominal pathology.
- Patients with any previous abdominal surgery or any significant systemic disease.
- Septic shock.
- Pregnancy/ Breast-feeding mothers.
- Participation in an additional drug or device study and inability to offer informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset
This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.
Read the detailed description
The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.
This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.
- Conditions
- Acute Calculous Cholecystitis
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Acute calculous cholecystitis, Laparoscopic cholecystectomy, Early laparoscopic cholecystectomy, Late 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
The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits
| Study group | Role | What they receive |
|---|---|---|
| LC within 72 hours of disease onset | Active comparator | Immediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients Receives: Procedure: Laparoscopic cholecystectomy |
| LC after 72 hours of disease onset | Active comparator | Late laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between early and late laparoscopic cholecystectomy regarding Operation time
comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes
Measured: intra-operative
Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation
comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy
Measured: intra-operative
comparison between early and late laparoscopic cholecystectomy regarding post operative pain
comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics
Measured: within 1month post operative
Duration of postoperative hospital stay
comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital
Measured: within 2 weeks post-operative
Secondary outcomes (3)
comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage
compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage
Measured: first 72 hours post-operative
comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding
compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding
Measured: 7 days postoperative
presence of any wound complication by examining the wound
comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative
Measured: within 10 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Oct 2017
- Primary completion1 Jan 2020
- Study completion1 Apr 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 Calculous 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elmahdy Ali Abdel Rahman Morsy, Assiut University
- Investigators
- Mohamed Elmahdy, Study chair, Assiut UniversityGamal Abdel Hameed, Study director, Assiut UniversityGamal Makhlouf, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477253
- Sponsor's protocol ID
- LC in management of ACC
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuval JB, Mizrahi I, Mazeh H, Weiss DJ, Almogy G, Bala M, Kuchuk E, Siam B, Simanovsky N, Eid A, Pikarsky AJ. Delayed Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis: Is it Time for a Change? World J Surg. 2017 Jul;41(7):1762-1768. doi: 10.1007/s00268-017-3928-4.
PubMed 28251270Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Correa LD, Alves CB, Guimaraes SF. Acute calculous cholecystitis: Review of current best practices. World J Gastrointest Surg. 2017 May 27;9(5):118-126. doi: 10.4240/wjgs.v9.i5.118.
PubMed 28603584Terho PM, Leppaniemi AK, Mentula PJ. Laparoscopic cholecystectomy for acute calculous cholecystitis: a retrospective study assessing risk factors for conversion and complications. World J Emerg Surg. 2016 Nov 16;11:54. doi: 10.1186/s13017-016-0111-4. eCollection 2016.
PubMed 27891173Bagla P, Sarria JC, Riall TS. Management of acute cholecystitis. Curr Opin Infect Dis. 2016 Oct;29(5):508-13. doi: 10.1097/QCO.0000000000000297.
PubMed 27429137Dudchenko MO, Kravtsiv MI, Lyulka MO, Lyakhovsky VI, Furman DD, Bondar LD. [TREATMENT OF ACUTE CALCULOUS CHOLECYSTITIS: "EARLY" OR "PLANNED" LAPAROSCOPIC CHOLECYSTECTMIVY]. Klin Khir. 2015 Jun;(6):19-21. Ukrainian.
PubMed 26521459Polo M, Duclos A, Polazzi S, Payet C, Lifante JC, Cotte E, Barth X, Glehen O, Passot G. Acute Cholecystitis-Optimal Timing for Early Cholecystectomy: a French Nationwide Study. J Gastrointest Surg. 2015 Nov;19(11):2003-10. doi: 10.1007/s11605-015-2909-x. Epub 2015 Aug 12.
PubMed 26264362
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset
- ClinicalTrials.gov ID
- NCT03477253
- Acronym / sponsor ID
- LC in management of ACC
- Conditions
- Acute Calculous Cholecystitis
- Keywords
- Acute calculous cholecystitis, Laparoscopic cholecystectomy, Early laparoscopic cholecystectomy, Late laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Mar 2018 (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.
This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.
Detailed description
The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.
This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A \& B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms
| Arm | Type | Receives |
|---|---|---|
| LC within 72 hours of disease onset | Active comparator | Procedure: Laparoscopic cholecystectomyImmediate laparoscopic cholecystectomy within 72 hours of the onset of symptoms was performed in these patients |
| LC after 72 hours of disease onset | Active comparator | Procedure: Laparoscopic cholecystectomyLate laparoscopic cholecystectomy after 72 hours of the onset of symptoms was performed in these patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
- Initial surgical management planned for immediate laparoscopic cholecystectomy.
- Patients who are fit for laparoscopy and general anesthesia.
- Patient who agree to provide short term outcome data and agree to provide contact information.
Key exclusion criteria (6 listed)
- Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
- Patients with other associated abdominal pathology.
- Patients with any previous abdominal surgery or any significant systemic disease.
- Septic shock.
- Pregnancy/ Breast-feeding mothers.
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 cholecystectomyThe use of laparoscopic cholecystectomy in management of acute calculous cholecysitits | Procedure or surgery | LC after 72 hours of disease onset, LC within 72 hours of disease onset |
Primary outcome
Comparison between early and late laparoscopic cholecystectomy regarding Operation time
Time frame: intra-operative
comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes
Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation
Time frame: intra-operative
comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy
comparison between early and late laparoscopic cholecystectomy regarding post operative pain
Time frame: within 1month post operative
comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics
Duration of postoperative hospital stay
Time frame: within 2 weeks post-operative
comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital
3 secondary outcomes
comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage
Time frame: first 72 hours post-operative
comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding
Time frame: 7 days postoperative
presence of any wound complication by examining the wound
Time frame: within 10 days post-operative
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 Apr 2021.
- Background: PubMed 28251270Yuval JB, Mizrahi I, Mazeh H, Weiss DJ, Almogy G, Bala M, Kuchuk E, Siam B, Simanovsky N, Eid A, Pikarsky AJ. Delayed Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis: Is it Time for a Change? World J Surg. 2017 Jul;41(7):1762-1768. doi: 10.1007/s00268-017-3928-4.
- Background: PubMed 28603584Gomes CA, Junior CS, Di Saverio S, Sartelli M, Kelly MD, Gomes CC, Gomes FC, Correa LD, Alves CB, Guimaraes SF. Acute calculous cholecystitis: Review of current best practices. World J Gastrointest Surg. 2017 May 27;9(5):118-126. doi: 10.4240/wjgs.v9.i5.118.
- Background: PubMed 27891173Terho PM, Leppaniemi AK, Mentula PJ. Laparoscopic cholecystectomy for acute calculous cholecystitis: a retrospective study assessing risk factors for conversion and complications. World J Emerg Surg. 2016 Nov 16;11:54. doi: 10.1186/s13017-016-0111-4. eCollection 2016.
- Background: PubMed 27429137Bagla P, Sarria JC, Riall TS. Management of acute cholecystitis. Curr Opin Infect Dis. 2016 Oct;29(5):508-13. doi: 10.1097/QCO.0000000000000297.
- Background: PubMed 26521459Dudchenko MO, Kravtsiv MI, Lyulka MO, Lyakhovsky VI, Furman DD, Bondar LD. [TREATMENT OF ACUTE CALCULOUS CHOLECYSTITIS: "EARLY" OR "PLANNED" LAPAROSCOPIC CHOLECYSTECTMIVY]. Klin Khir. 2015 Jun;(6):19-21. Ukrainian.
- Background: PubMed 26264362Polo M, Duclos A, Polazzi S, Payet C, Lifante JC, Cotte E, Barth X, Glehen O, Passot G. Acute Cholecystitis-Optimal Timing for Early Cholecystectomy: a French Nationwide Study. J Gastrointest Surg. 2015 Nov;19(11):2003-10. doi: 10.1007/s11605-015-2909-x. Epub 2015 Aug 12.
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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 Elmahdy study chair
Assiut University
Gamal Abdel Hameed study director
Assiut University
Gamal Makhlouf principal investigator
Assiut University
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 Assiut 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 4 inclusion and 6 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 Apr 2021. 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?
Comparison between early and late laparoscopic cholecystectomy regarding Operation time (time frame: intra-operative). 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 NCT03477253, 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 Apr 2021.