Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)
NCT ID: NCT06193837
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-01-01
2026-01-01
Brief Summary
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Detailed Description
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Routine antibiotic prophylaxis in LC decreases the rate of intra and post operative infections specifically the 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 and prolongation of hospitalization time \[5\]. 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 1 month post operative. In our study we Follow both outcomes to compare between both techniques
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group 1
Having prophylactic antibiotic in laparoscopic cholecystectomy
Augmentin
Use of prophylactic antibiotics in lap cholecystectomy
Group 2
Not having prophylactic antibiotics in laparoscopic cholecystectomy
No interventions assigned to this group
Interventions
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Augmentin
Use of prophylactic antibiotics in lap cholecystectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic gall bladder stones.
* Ultrasonography shows gall bladder stones.
* Uncomplicated chronic calculous cholecystitis
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Hassan Mohammed Ali
Assiut Lecturer
Principal Investigators
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Mostafa M. Mohammad Sayed, Dr
Role: STUDY_DIRECTOR
General Surgery department of Assiut University
Ahmed M. Ibrahim Taha, Dr
Role: STUDY_DIRECTOR
General Surgery department of Assiut University
Central Contacts
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References
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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.
Yan 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.
Other Identifiers
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Prophylactic Antibiotic in LC
Identifier Type: -
Identifier Source: org_study_id
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