AppendicitisNCT02404064
Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?
A study testing cefamezin 1g IV and metronidazole 500 mg IV in people with Appendicitis, run by HaEmek Medical Center, Israel.
Trial summary
To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- cefamezin 1g IV and metronidazole 500 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.
Who cannot join
- Patients with a documented allergy to any of the medications in the trial.
- Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter? Randomized Control Trial
To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.
Read the detailed description
Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations.
Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .
- Conditions
- Appendicitis
- Being tested
- cefamezin 1g IV, metronidazole 500 mg IV, Placebo
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefamezin 1g IVDrug
Also called Cefotaxime
perioperative antibiotics (Cefamizin 1g IV; )
metronidazole 500 mg IVDrug
Also called falgyl
perioperative antibiotics (metronidazole 500 mg IV )
PlaceboDrug
No perioperative antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics perioperative | Other | dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department Receives: Drug: cefamezin 1g IV; Drug: metronidazole 500 mg IV |
| placebo - No Antibiotics perioperative | Placebo comparator | The intervention is No Antibiotics perioperative Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).
Criteria for a superficial incisional SSI are an infection occurring at the incision site within 30 days after surgery that involved only the skin and subcutaneous tissue and at least one of the following:
purulent drainage from the incision; an organism isolated from a culture of fluid from the superficial incision; incisional pain, tenderness, localized swelling, redness, or heat, and the wound was opened;
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 posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Hershko, HaEmek Medical Center, Israel
- Investigators
- Dan Hershko, Professor, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404064
- Sponsor's protocol ID
- 134-14
- Status last verified
- Mar 2015
- First submitted
- 15 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter? Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02404064
- Acronym / sponsor ID
- 134-14
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 31 Mar 2015 (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.
To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.
Detailed description
Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations.
Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics perioperative | Other | Drug: cefamezin 1g IV, Drug: metronidazole 500 mg IVdose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department |
| placebo - No Antibiotics perioperative | Placebo comparator | Drug: PlaceboThe intervention is No Antibiotics perioperative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.
Key exclusion criteria (2 listed)
- Patients with a documented allergy to any of the medications in the trial.
- Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study
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 |
|---|---|---|
| cefamezin 1g IVAlso: Cefotaximeperioperative antibiotics (Cefamizin 1g IV; ) | Drug | Antibiotics perioperative |
| metronidazole 500 mg IVAlso: falgylperioperative antibiotics (metronidazole 500 mg IV ) | Drug | Antibiotics perioperative |
| PlaceboNo perioperative antibiotics | Drug | placebo - No Antibiotics perioperative |
Primary outcome
The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).
Time frame: 30 Days
Criteria for a superficial incisional SSI are an infection occurring at the incision site within 30 days after surgery that involved only the skin and subcutaneous tissue and at least one of the following: purulent drainage from the incision; an organism isolated from a culture of fluid from the superficial incision; incisional pain, tenderness, localized swelling, redness, or heat, and the wound was opened;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Dan Hershko, Professor principal investigator
haemek medical center
Questions about this trial
What is this clinical trial studying?
A study testing cefamezin 1g IV and metronidazole 500 mg IV in people with Appendicitis, run by HaEmek Medical Center, 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 1 inclusion and 2 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Dan Hershko, Professor (972+46494391, dan_he@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC). (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2015.