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

Not yet recruiting

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Drug: Augmentin

• Registration Number: NCT06193837
• Lead Sponsor: Assiut University

Brief Summary

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

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study Start: 2024-01-01
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-08-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Augmentin	Having prophylactic antibiotic in laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
To compare between infection rate at both groups	Baseline	Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Hospitalization time	Baseline	Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC

Secondary Outcome Measures

Name	Time	Method
Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis	Baseline	Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC