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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06193837
Other study ID # Prophylactic Antibiotic in LC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2026

Study information

Verified date December 2023
Source Assiut University
Contact Ahmed H. Mohammed Ali, MD
Phone +201022033689
Email ahmedhsnmhmd@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To Compare between outcomes of Antibiotic Prophylaxis and No antibiotic prophylaxis in non-complicated low risk laparoscopic cholecystectomy


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 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 1, 2026
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Augmentin
Use of prophylactic antibiotics in lap cholecystectomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To compare between infection rate at both groups Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC Baseline
Primary Hospitalization time Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC Baseline
Secondary Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC Baseline
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