Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06193837
• Other study ID #: Prophylactic Antibiotic in LC
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic

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