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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06193837
Enrollment
200
Registered
2024-01-05
Start date
2024-01-01
Completion date
2026-01-01
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy, Laparoscopic

Keywords

Antibiotic, Lap cholecystectomy

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

Interventions

Use of prophylactic antibiotics in lap cholecystectomy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To compare between infection rate at both groupsBaselineGroup 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Hospitalization timeBaselineGroup 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC

Secondary

MeasureTime frameDescription
Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitisBaselineGroup 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC

Contacts

Primary ContactAhmed H. Mohammed Ali, MD
ahmedhsnmhmd@gmail.com+201022033689
Backup ContactMoursy M. Moursy, Prof
morssy@aun.edu.eg+201006727303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026