Cholecystectomy, LaparoscopicNCT06193837
Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)
An observational study of Cholecystectomy, Laparoscopic, run by Assiut University at 1 site in Egypt.
Trial summary
To Compare between outcomes of Antibiotic prophylaxis and no antibiotic prophylaxis in low risk non-complicated laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Cefazoline
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with symptomatic chronic calcular cholecystitis with age above 18 years and fit for surgery. They should be with low-risk (Not immuno-compromized) and non-complicated cases.
Who may be able to join
- Adult male and female at the Age of 18 years or above.
- Symptomatic gall bladder stones.
- Ultrasonography shows gall bladder stones.
- Uncomplicated chronic calculous cholecystitis
Who cannot join
- Complicated gall bladder stones.
- Malignant gall bladder mass
- Laparoscopic cholecystectomy with Common Bile Duct (CBD) exploration.
- Absolute contraindications to LC like cardiovascular, pulmonary disease, coagulopathies and end stage liver disease.
- The cases of Laparoscopic Cholecystectomy conversion to Open Cholecystectomy due to equipment failure.
- Immunocompromised patients as Uncontrolled DM, HIV and patients on certain medications as corticosteroids and chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.
To Compare between outcomes of Antibiotic prophylaxis and no antibiotic prophylaxis in low risk non-complicated laparoscopic cholecystectomy
Read the detailed description
There is no doubt that Laparoscopic cholecystectomy (LC) is the surgery of choice in cholelithiasis [1].
Routine antibiotic prophylaxis in LC decreases the rate of the overall infectious complications especially surgical site infection (SSI) [2]. However, the rate of antibiotic side effects remains considerable, mainly antibiotic resistance to the commonly used antibiotics as Cefoperazone and other antibiotics used in routine prophylaxis [3]. So Some studies proved that no need for antibiotic prophylaxis [4]. In spite, no antibiotic prophylaxis may lead to infections mainly SSI, prolongation of hospitalization time and possibilities of rehospitalization [5]. However None of these studies has proved superiority over the other and stills a matter of controversy [6]. For this reason more efforts are directed to limit the use of antibiotic in non complicated low risk laparoscopic cholecystectomy. Prophylaxis in this study is directed to start from time of admission till next routine postoperative follow-up which is about ten days postoperative. In our study we follow both outcomes to compare between both techniques.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Cefazoline
- Keywords
- Antibiotic, Lap cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolineDrug
Use of cefazoline 2gm inravenously as a prophylactic antibiotic in lap cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not receiving prophylactic antibiotic in laparoscopic cholecystectomy | |
| Group 2 | The group receiving a prophylactic antibiotic in laparoscopic cholecystectomy Receives: Drug: Cefazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection (SSI)
Percentage of patients with SSI (superficial/deep/organ-space) per CDC/NHSN criteria, assessed clinically
Measured: Within 30 days after surgery
Change in serum CRP
CRP (mg/L) measured by lab assay, pre-op vs post-op
Measured: Baseline (within 24 hours before surgery) and 24 hours after surgery
Change in total leucocyte count (TLC)
TLC (×10⁹/L) by CBC, pre-op vs post-op
Measured: Baseline (within 24 hours before surgery) and 24 hours after surgery
Secondary outcomes (3)
Length of postoperative hospital stay
Hours from end of surgery to discharge
Measured: From end of surgery until discharge, up to 7 days
Rate of hospital readmission
Percentage of patients readmitted for any LC-related complication
Measured: Within 30 days after surgery
Quality of life score (GIQLI)
Gastrointestinal Quality of Life Index (0-144)
Measured: Baseline (before surgery) and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Mohammed Ali, Assiut University
- Investigators
- Mostafa M. Mohammad Sayed, Dr, Study director, General Surgery department of Assiut UniversityAhmed M. Ibrahim Taha, Dr, Study director, General Surgery department of Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193837
- Sponsor's protocol ID
- Prophylactic Antibiotic in LC
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kim HJ, Kang SH, Roh YH, Kim MC, Kim KW. Are prophylactic antibiotics necessary in elective laparoscopic cholecystectomy, regardless of patient risk? Ann Surg Treat Res. 2017 Aug;93(2):76-81. doi: 10.4174/astr.2017.93.2.76. Epub 2017 Jul 28.
PubMed 28835883Yan RC, Shen SQ, Chen ZB, Lin FS, Riley J. The role of prophylactic antibiotics in laparoscopic cholecystectomy in preventing postoperative infection: a meta-analysis. J Laparoendosc Adv Surg Tech A. 2011 May;21(4):301-6. doi: 10.1089/lap.2010.0436. Epub 2011 Mar 28.
PubMed 21443433
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT06193837
- Acronym / sponsor ID
- Prophylactic Antibiotic in LC
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- Antibiotic, Lap cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Jan 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.
To Compare between outcomes of Antibiotic prophylaxis and no antibiotic prophylaxis in low risk non-complicated laparoscopic cholecystectomy
Detailed description
There is no doubt that Laparoscopic cholecystectomy (LC) is the surgery of choice in cholelithiasis [1].
Routine antibiotic prophylaxis in LC decreases the rate of the overall infectious complications especially surgical site infection (SSI) [2]. However, the rate of antibiotic side effects remains considerable, mainly antibiotic resistance to the commonly used antibiotics as Cefoperazone and other antibiotics used in routine prophylaxis [3]. So Some studies proved that no need for antibiotic prophylaxis [4]. In spite, no antibiotic prophylaxis may lead to infections mainly SSI, prolongation of hospitalization time and possibilities of rehospitalization [5]. However None of these studies has proved superiority over the other and stills a matter of controversy [6]. For this reason more efforts are directed to limit the use of antibiotic in non complicated low risk laparoscopic cholecystectomy. Prophylaxis in this study is directed to start from time of admission till next routine postoperative follow-up which is about ten days postoperative. In our study we follow both outcomes to compare between both techniques.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Not receiving prophylactic antibiotic in laparoscopic cholecystectomy |
| Group 2 | – | Drug: CefazolineThe group receiving a prophylactic antibiotic in laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with symptomatic chronic calcular cholecystitis with age above 18 years and fit for surgery. They should be with low-risk (Not immuno-compromized) and non-complicated cases.
Key inclusion criteria (4 listed)
- Adult male and female at the Age of 18 years or above.
- Symptomatic gall bladder stones.
- Ultrasonography shows gall bladder stones.
- Uncomplicated chronic calculous cholecystitis
Key exclusion criteria (6 listed)
- Complicated gall bladder stones.
- Malignant gall bladder mass
- Laparoscopic cholecystectomy with Common Bile Duct (CBD) exploration.
- Absolute contraindications to LC like cardiovascular, pulmonary disease, coagulopathies and end stage liver disease.
- The cases of Laparoscopic Cholecystectomy conversion to Open Cholecystectomy due to equipment failure.
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 |
|---|---|---|
| CefazolineUse of cefazoline 2gm inravenously as a prophylactic antibiotic in lap cholecystectomy | Drug | Group 2 |
Primary outcome
Incidence of surgical site infection (SSI)
Time frame: Within 30 days after surgery
Percentage of patients with SSI (superficial/deep/organ-space) per CDC/NHSN criteria, assessed clinically
Change in serum CRP
Time frame: Baseline (within 24 hours before surgery) and 24 hours after surgery
CRP (mg/L) measured by lab assay, pre-op vs post-op
Change in total leucocyte count (TLC)
Time frame: Baseline (within 24 hours before surgery) and 24 hours after surgery
TLC (×10⁹/L) by CBC, pre-op vs post-op
3 secondary outcomes
Length of postoperative hospital stay
Time frame: From end of surgery until discharge, up to 7 days
Rate of hospital readmission
Time frame: Within 30 days after surgery
Quality of life score (GIQLI)
Time frame: Baseline (before surgery) and 30 days after surgery
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 Oct 2026.
- Background: PubMed 28835883Kim HJ, Kang SH, Roh YH, Kim MC, Kim KW. Are prophylactic antibiotics necessary in elective laparoscopic cholecystectomy, regardless of patient risk? Ann Surg Treat Res. 2017 Aug;93(2):76-81. doi: 10.4174/astr.2017.93.2.76. Epub 2017 Jul 28.
- Background: PubMed 21443433Yan RC, Shen SQ, Chen ZB, Lin FS, Riley J. The role of prophylactic antibiotics in laparoscopic cholecystectomy in preventing postoperative infection: a meta-analysis. J Laparoendosc Adv Surg Tech A. 2011 May;21(4):301-6. doi: 10.1089/lap.2010.0436. Epub 2011 Mar 28.
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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.
Mostafa M. Mohammad Sayed, Dr study director
General Surgery department of Assiut University
Ahmed M. Ibrahim Taha, Dr study director
General Surgery department of Assiut University
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 Cholecystectomy, Laparoscopic, 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 13 Oct 2026. 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?
Incidence of surgical site infection (SSI) (time frame: Within 30 days after surgery). The study lists 3 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 NCT06193837, which also lists 2 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 13 Oct 2026.