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

NCT ID: NCT06193837

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

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

Detailed Description

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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

Conditions

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Cholecystectomy, Laparoscopic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Having prophylactic antibiotic in laparoscopic cholecystectomy

Augmentin

Intervention Type DRUG

Use of prophylactic antibiotics in lap cholecystectomy

Group 2

Not having prophylactic antibiotics in laparoscopic cholecystectomy

No interventions assigned to this group

Interventions

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Augmentin

Use of prophylactic antibiotics in lap cholecystectomy

Intervention Type DRUG

Other Intervention Names

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laparoscopy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Hassan Mohammed Ali

Assiut Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa M. Mohammad Sayed, Dr

Role: STUDY_DIRECTOR

General Surgery department of Assiut University

Ahmed M. Ibrahim Taha, Dr

Role: STUDY_DIRECTOR

General Surgery department of Assiut University

Central Contacts

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Ahmed H. Mohammed Ali, MD

Role: CONTACT

+201022033689

Moursy M. Moursy, Prof

Role: CONTACT

+201006727303

References

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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.

Reference Type BACKGROUND
PMID: 28835883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21443433 (View on PubMed)

Other Identifiers

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Prophylactic Antibiotic in LC

Identifier Type: -

Identifier Source: org_study_id

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