Infection WoundPhase 4NCT06607887
The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy
A Phase 4 study testing IV antibiotic and Oral antibiotic in people with Infection Wound and Antibiotic Resistant Infection, run by Minia University Hospital at 1 site in Egypt.
Trial summary
Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Wound, Antibiotic Resistant Infection
- What is being tested?
- IV antibiotic and Oral antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to 30 Dec 2024
- 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
- Adult patients (aged above 18 years) undergoing laparoscopic cholecystectomy.
Who cannot join
- patients with comorbidities (Diabetes, malignancies, Immunosuppressed). Lost of follow-up. Patients received antibiotics within 72 hr before admission. Complicated cases involved, gangrenous and perforated cholecystitis and abscess.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya
asmaa Elsayed, Ph.D.
About this study
Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection.
- Conditions
- Infection Wound, Antibiotic Resistant Infection
- Being tested
- IV antibiotic, Oral antibiotic
- Keywords
- antibiotic, prophylaxis, cholecystectomy, postoperative
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV antibioticDrug
Parenteral prophylactic antibiotics (cefazolin), 1st dose at the time of induction of anesthesia, 2nd dose after 12hs from the surgery.
Oral antibioticDrug
Parenteral prophylactic antibiotic (cefazolin), dose at the time of induction of anesthesia and then oral antibiotic for five days postoperative.
| Study group | Role | What they receive |
|---|---|---|
| IV antibiotic | Experimental | Not described Receives: Drug: IV antibiotic |
| Oral Antibiotic | Active comparator | Not described Receives: Drug: Oral antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
DSSI = deep surgical site infection; SSSI = superficial surgical site infection.
Measured: 4 weeks
Secondary outcomes (3)
Fever
Measured: 4 weeks
Length of the hospital stay
Measured: 4 weeks
Hematoma and Seroma formation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start30 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection WoundStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa A. Elsayed, Sohag University
- Investigators
- Asmaa A Elsayed, Ph.D., Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607887
- Sponsor's protocol ID
- Antibiotic77
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06607887
- Acronym / sponsor ID
- Antibiotic77
- Conditions
- Infection Wound, Antibiotic Resistant Infection
- Keywords
- antibiotic, prophylaxis, cholecystectomy, postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minia University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Sep 2024 (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.
Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV antibiotic | Experimental | Drug: IV antibiotic |
| Oral Antibiotic | Active comparator | Drug: Oral antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (aged above 18 years) undergoing laparoscopic cholecystectomy.
Key exclusion criteria (1 listed)
- patients with comorbidities (Diabetes, malignancies, Immunosuppressed). Lost of follow-up. Patients received antibiotics within 72 hr before admission. Complicated cases involved, gangrenous and perforated cholecystitis and abscess.
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 |
|---|---|---|
| IV antibioticParenteral prophylactic antibiotics (cefazolin), 1st dose at the time of induction of anesthesia, 2nd dose after 12hs from the surgery. | Drug | IV antibiotic |
| Oral antibioticParenteral prophylactic antibiotic (cefazolin), dose at the time of induction of anesthesia and then oral antibiotic for five days postoperative. | Drug | Oral Antibiotic |
Primary outcome
Surgical site infection
Time frame: 4 weeks
DSSI = deep surgical site infection; SSSI = superficial surgical site infection.
3 secondary outcomes
Fever
Time frame: 4 weeks
Length of the hospital stay
Time frame: 4 weeks
Hematoma and Seroma formation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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.
Asmaa A Elsayed, Ph.D. principal investigator
Sohag University
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 IV antibiotic and Oral antibiotic in people with Infection Wound and Antibiotic Resistant Infection, run by Minia University Hospital 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 23 Sep 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa A Elsayed (01095727201, asmaa.abdelfattah@pharm.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 4 weeks). 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 23 Sep 2024.