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

NCT06193837 | Unknown

• 1 other identifier: Prophylactic Antibiotic in LC
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cholecystectomy, Laparoscopic

Keywords

Antibiotic; Lap cholecystectomy

Outcome Measures

Primary Outcomes (2)

• To compare between infection rate at both groups

  Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC

  Baseline

• Hospitalization time

  Group 1; Prophylactic Antibiotics in LC and Group 2; No prophylactic antibiotics in LC

  Baseline

Secondary Outcomes (1)

• Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis

  Baseline

Study Arms (2)

Group 1

Having prophylactic antibiotic in laparoscopic cholecystectomy

Drug: Augmentin

Group 2

Not having prophylactic antibiotics in laparoscopic cholecystectomy

Interventions

Augmentin DRUG

Use of prophylactic antibiotics in lap cholecystectomy

Also known as: laparoscopy

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 28835883 BACKGROUND

• 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.

  PMID: 21443433 BACKGROUND

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Laparoscopy

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mostafa M. Mohammad Sayed, Dr

  General Surgery department of Assiut University

  STUDY DIRECTOR

• Ahmed M. Ibrahim Taha, Dr

  General Surgery department of Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed H. Mohammed Ali, MD

CONTACT

+201022033689; ahmedhsnmhmd@gmail.com

Moursy M. Moursy, Prof

CONTACT

+201006727303; morssy@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut Lecturer

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 5, 2024

Record last verified: 2023-12