Clinical trial NCT06193837: Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)
Official title: Prophylactic Antibiotic in Non-complicated Low Risk Laparoscopic Cholecystectomy; Is it Worthy? A Prospective Randomized Comparative Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholecystectomy, Laparoscopic
Keywords: Antibiotic
Lap cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: To compare between infection rate at both groups
timeFrame: Baseline
measure: Hospitalization time
timeFrame: Baseline
Secondary outcomes:
measure: Improve quality of life to reduce mortality and morbidity in patients with chronic cholecystitis
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: General Surgery department of Assiut University
name: Mostafa M. Mohammad Sayed, Dr
role: STUDY_DIRECTOR
affiliation: General Surgery department of Assiut University
name: Ahmed M. Ibrahim Taha, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.