Acute CholecystititsNCT00557453
The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial
An observational study of Acute Cholecystitits, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or delayed surgery. To date there are no randomized trials proving the benefit of antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Cholecystitits
- What is being tested?
- Antibiotic treatment and No antibiotics
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Apr 2010
- Phase
- Observational
- 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
Study population: Patients admitted through the emergency department that are diagnosed with acute cholecystits and meet the inclusion criteria will be given the opportunity to participate in the trial. Informed consent is required. Patients may withdraw from the study at any time without giving reasons and without jeopardizing further treatment.
Who may be able to join
- Patients with the diagnosis of mild acute cholecystitis that meet the following:
- Sonographic (or CT) findings:
- cholelithiasis or sludge and
- wall thickening > 4 mm, and
- positive sonographic Murphy sign,
- distended gallbladder (optional)
Show all 11Show fewer
- pericystic fluid (optional)
- Additional one of the following:
- epigastric or RUQ pain
- fever > 38.0
- WBC > 10,000
Who cannot join
- Age - less than 18 or above 70
- Pregnant females
- Unconsentable patients
- NYHA > 3
- Use of steroids or immunosuppression
- Onset of typical abdominal pain for over than 72 hours
Show all 14Show fewer
- Hemodynamic instability
- Fever > 39 or chills
- Palpable inflammatory RUQ mass
- Presence of peritonitis on physical examination
- WBC > 18,000
- Diastase > 200 (NL 20-100)
- Bilirubin > 85 (X5 the norm)
- Multi organ failure
Trial locations and contacts
1 site in 1 country.
About this study
The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or delayed surgery. To date there are no randomized trials proving the benefit of antibiotic treatment.
The aim of this study is to prospectively and randomly compare between patients that are admitted for acute cholecystitis and treated with or without antibiotics.
Read the detailed description
Cholelithiasis and inflammatory biliary tract disease constitute a major health problem in western countries. Acute cholecystitis is the third major cause of emergency admission to a surgical ward and its incidence increases with increasing age. Acute cholecystitis is defined as acute inflammation of the gallbladder which is commonly caused by gallstones which are impacted in the cystic duct. The treatment of acute cholecystitis varies between different medical centers around the world. In some hospitals, mainly in the US, the most common treatment is early laparoscopic cholecystectomy within 72 hours from the onset of symptoms / admission. However, in the UK and many other centers in Europe the treatment of acute cholecystitis is conservative (NPO, IV fluids and antibiotics) and laparoscopic cholecystectomy is delayed. The reasons for delayed surgery differ between institutions and include the assumption of decreased complications, surgeon and OR availability and schedule, costs, and hospital policy.
A recent metanalysis proved similar safety and efficacy of early and delayed laparoscopic cholecystectomy. The conversion rate, length of operation and complication rate (overall complication rate, intra-abdominal collection, bile leak, and CBD injury) were also comparable.
At Hadassah-Hebrew University Medical Center, Mount Scopus patients with acute cholecystitis are treated conservatively followed by delayed laparoscopic cholecystectomy. Over the years this approach proved to carry relatively low rate of complications, mainly bile duct injuries <1%, without interruption to the busy OR schedule.
Regardless to the lack of evidence based guidelines for the treatment of acute cholecystitis the traditional triad of NPO, IV fluids and antibiotics was adopted at our institution vis-à-vis the higher complication and conversion rate for early cholecystectomy. The antibiotic treatment is associated with side effects, costs and most important unavoidable development of bacterial drug resistance. However, to date there are no randomized trials proving the superiority of either one of these methods.
- Conditions
- Acute Cholecystitits
- Being tested
- Antibiotic treatment, No antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatmentDrug
Cefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement.
No antibioticsDrug
Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.
| Study group | Role | What they receive |
|---|---|---|
| A | Antibiotic treatment Receives: Drug: Antibiotic treatment | |
| B | Non antibiotic treatment Receives: Drug: No antibiotics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystititsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Haggi Mazeh, M.D., Principal investigator, Hadassah Medical OrganizationHerbert R Freund, M.D., Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557453
- Sponsor's protocol ID
- cholecystitis-HMO-CTIL
- Status last verified
- Apr 2010
- First submitted
- 11 Nov 2007
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshida M, Takada T, Kawarada Y, Tanaka A, Nimura Y, Gomi H, Hirota M, Miura F, Wada K, Mayumi T, Solomkin JS, Strasberg S, Pitt HA, Belghiti J, de Santibanes E, Fan ST, Chen MF, Belli G, Hilvano SC, Kim SW, Ker CG. Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):83-90. doi: 10.1007/s00534-006-1160-y. Epub 2007 Jan 30.
PubMed 17252301
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00557453
- Acronym / sponsor ID
- cholecystitis-HMO-CTIL
- Conditions
- Acute Cholecystitits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Nov 2007 (estimated)
- 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 treatment of acute cholecystitis includes limited oral intake, antibiotics and early or delayed surgery. To date there are no randomized trials proving the benefit of antibiotic treatment.
The aim of this study is to prospectively and randomly compare between patients that are admitted for acute cholecystitis and treated with or without antibiotics.
Detailed description
Cholelithiasis and inflammatory biliary tract disease constitute a major health problem in western countries. Acute cholecystitis is the third major cause of emergency admission to a surgical ward and its incidence increases with increasing age. Acute cholecystitis is defined as acute inflammation of the gallbladder which is commonly caused by gallstones which are impacted in the cystic duct. The treatment of acute cholecystitis varies between different medical centers around the world. In some hospitals, mainly in the US, the most common treatment is early laparoscopic cholecystectomy within 72 hours from the onset of symptoms / admission. However, in the UK and many other centers in Europe the treatment of acute cholecystitis is conservative (NPO, IV fluids and antibiotics) and laparoscopic cholecystectomy is delayed. The reasons for delayed surgery differ between institutions and include the assumption of decreased complications, surgeon and OR availability and schedule, costs, and hospital policy.
A recent metanalysis proved similar safety and efficacy of early and delayed laparoscopic cholecystectomy. The conversion rate, length of operation and complication rate (overall complication rate, intra-abdominal collection, bile leak, and CBD injury) were also comparable.
At Hadassah-Hebrew University Medical Center, Mount Scopus patients with acute cholecystitis are treated conservatively followed by delayed laparoscopic cholecystectomy. Over the years this approach proved to carry relatively low rate of complications, mainly bile duct injuries <1%, without interruption to the busy OR schedule.
Regardless to the lack of evidence based guidelines for the treatment of acute cholecystitis the traditional triad of NPO, IV fluids and antibiotics was adopted at our institution vis-à-vis the higher complication and conversion rate for early cholecystectomy. The antibiotic treatment is associated with side effects, costs and most important unavoidable development of bacterial drug resistance. However, to date there are no randomized trials proving the superiority of either one of these methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Antibiotic treatmentAntibiotic treatment |
| B | – | Drug: No antibioticsNon antibiotic treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted through the emergency department that are diagnosed with acute cholecystits and meet the inclusion criteria will be given the opportunity to participate in the trial. Informed consent is required. Patients may withdraw from the study at any time without giving reasons and without jeopardizing further treatment.
Key inclusion criteria (11 listed)
- Sonographic (or CT) findings:
- Additional one of the following:
Key exclusion criteria (14 listed)
- Age - less than 18 or above 70
- Pregnant females
- Unconsentable patients
- NYHA > 3
- Use of steroids or immunosuppression
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 |
|---|---|---|
| Antibiotic treatmentCefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement. | Drug | A |
| No antibioticsAllowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated. | Drug | B |
Primary outcome
Not reported in the source record.
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 13 Jul 2010.
- Background: PubMed 17252301Yoshida M, Takada T, Kawarada Y, Tanaka A, Nimura Y, Gomi H, Hirota M, Miura F, Wada K, Mayumi T, Solomkin JS, Strasberg S, Pitt HA, Belghiti J, de Santibanes E, Fan ST, Chen MF, Belli G, Hilvano SC, Kim SW, Ker CG. Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):83-90. doi: 10.1007/s00534-006-1160-y. Epub 2007 Jan 30.
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.
Haggi Mazeh, M.D. principal investigator
Hadassah Medical Organization
Herbert R Freund, M.D. study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitits, run by Hadassah Medical Organization at 1 site in Israel.
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 11 inclusion and 14 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 13 Jul 2010. 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 Israel. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557453, which also lists 1 linked publication.
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 13 Jul 2010.