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

December 21, 2023 updated by: Ahmed Hassan Mohammed Ali, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients with symptomatic chronic calcular cholecystitis with age above 18 years and fit for surgery. They should be with low-risk (Not immuno-compromized) and non-complicated cases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Having prophylactic antibiotic in laparoscopic cholecystectomy
Drug: Augmentin
Use of prophylactic antibiotics in lap cholecystectomy
Other Names:
  • laparoscopy
Group 2
Not having prophylactic antibiotics in laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare between infection rate at both groups
Time Frame: Baseline
Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Baseline
Hospitalization time
Time Frame: Baseline
Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis
Time Frame: Baseline
Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mostafa M. Mohammad Sayed, Dr, General Surgery department of Assiut University
  • Study Director: Ahmed M. Ibrahim Taha, Dr, General Surgery department of Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prophylactic Antibiotic in LC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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