CholelithiasisPhase 4NCT01888822
Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
A Phase 4 study testing Ciprofloxacin and Ampicillin-sulbactam in people with Cholelithiasis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Ciprofloxacin and Ampicillin-sulbactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Jun 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy;
- patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.
Who cannot join
- acute cholecystitis;
- acute cholangitis;
- acute pancreatitis;
- pregnant or lactating women;
- antibiotic allergy;
- antibiotic therapy within 48 hours to 7 days prior to surgery;
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- clinically active infection at the moment of surgery;
- evidence of common bile duct stones;
- contraindications for laparoscopic cholecystectomy;
- no other additional procedure;
- indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).
- patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
Read the detailed description
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.
- Conditions
- Cholelithiasis
- Being tested
- Ciprofloxacin, Ampicillin-sulbactam, Placebo
- Keywords
- Laparoscopic cholecystectomy, Prophylactic antibiotics
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
Ampicillin-sulbactamDrug
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
PlaceboDrug
Prophylactic placebo infusion before elective laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. Receives: Drug: Placebo |
| Ampicillin-sulbactam | Active comparator | Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. Receives: Drug: Ampicillin-sulbactam |
| Ciprofloxacin | Active comparator | Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.
Measured: 30 days after operation
Secondary outcomes (3)
Extra-abdominal infections
Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
Measured: 30 days
Adverse events.
Adverse events, defined as allergic reactions to antibiotics.
Measured: 30 days
Quality of life
Quality of life measured with the 36-Item Short Form Health Survey
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 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionJun 2017
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 CholelithiasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erasmo Spaziani, University of Roma La Sapienza
- Investigators
- Erasmo Spaziani, MD, PhD, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888822
- Sponsor's protocol ID
- MarPic63
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;2010(12):CD005265. doi: 10.1002/14651858.CD005265.pub2.
PubMed 21154360
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01888822
- Acronym / sponsor ID
- MarPic63
- Conditions
- Cholelithiasis
- Keywords
- Laparoscopic cholecystectomy, Prophylactic antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Jun 2013 (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 trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
Detailed description
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
| Ampicillin-sulbactam | Active comparator | Drug: Ampicillin-sulbactamIntravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinIntravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective laparoscopic cholecystectomy;
- patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.
Key exclusion criteria (12 listed)
- acute cholecystitis;
- acute cholangitis;
- acute pancreatitis;
- pregnant or lactating women;
- antibiotic allergy;
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 |
|---|---|---|
| CiprofloxacinProphylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy | Drug | Ciprofloxacin |
| Ampicillin-sulbactamProphylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy | Drug | Ampicillin-sulbactam |
| PlaceboProphylactic placebo infusion before elective laparoscopic cholecystectomy | Drug | Placebo |
Primary outcome
Surgical site infection
Time frame: 30 days after operation
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.
3 secondary outcomes
Extra-abdominal infections
Time frame: 30 days
Adverse events.
Time frame: 30 days
Quality of life
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 21154360Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;2010(12):CD005265. doi: 10.1002/14651858.CD005265.pub2.
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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.
Erasmo Spaziani, MD, PhD study director
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin and Ampicillin-sulbactam in people with Cholelithiasis, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Mar 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Surgical site infection (time frame: 30 days after operation). 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 NCT01888822, 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 25 Mar 2020.