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

A

Assiut University

Status

Not yet enrolling

Conditions

Cholecystectomy, Laparoscopic

Treatments

Drug: Augmentin

Study type

Observational

Funder types

Other

Identifiers

NCT06193837
Prophylactic Antibiotic in LC

Details and patient eligibility

About

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

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Group 1
Description:
Having prophylactic antibiotic in laparoscopic cholecystectomy
Treatment:
Drug: Augmentin
Group 2
Description:
Not having prophylactic antibiotics in laparoscopic cholecystectomy

Trial contacts and locations

0

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Central trial contact

Ahmed H. Mohammed Ali, MD; Moursy M. Moursy, Prof

Data sourced from clinicaltrials.gov

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