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IRCT20201023049120N1 IRCT 2021-04-01 Tehran University of Medical Sciences Effect of Antibiotics in superficial and deep infection after cholecystectomy Evaluation of the effect of antibiotics after surgery in patients with mild to moderate cholecystitis on the rate of infection at the site of surgery and deep infection 2019-03-21 anticipated 60 Complete https://irct.ir/trial/51828 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, patients with mild to moderate acute cholecystitis after surgery were randomly divided to two separate groups: group A (receiving antibiotic therapy after surgery) and group B (not receiving antibiotic therapy after surgery). The patients are divided into two groups by simple randomization method and using Microsoft Excel 2013 software by random numbers (the admission code is randomized by the software) and with a ratio of 1 to 1. The surgeon doesn't aware of classification of patients into groups A and B and only the executor of the project is aware of the classification process. In fact, after the surgery, all the orders required by the patients are the responsibility of the executor of the project, and no one other than him/her is involved in the post-operation process and has no information. N/A Cholecystitis. Intervention 1: Intervention group: Patients in the intervention group (postoperative antibiotic therapy) are treated with oral antibiotics with ciprofloxacin 500 mg every 12 hours and metronidazole 250 mg every eight hours for up to 5 days after surgery. Patients who are unable to receive oral antibiotics will be treated with an intravenous antibiotic regimen including ceftriaxone, 1 g every 12 hours and metronidazole 500 mg every 8 hours until PO is completed. Intervention 2: Control group: Patients with mild to moderate acute cholecystitis who do not receive post operative antibiotic treatment and are evaluated for surgical site infection rate and deep infection within the first 30 days after surgery. Yes - There is a plan to make this available What will be shared: All information used for this study can be shared after making patients unidentifiable. Statistical information, data analysis, study method, findings and conclusions can also be shared When: For ever To whom: Every body Conditions: Due to re-analysis the data and repeat the study Where to obtain: Dr Hossein Zabihi Mahmoudabadi, hzabihim@tums.ac.ir How to obtain: Getting an ethical code, authenticating and collecting data and getting conclusions from the study in order to use it Comments:
public Hossein Zabihi Mahmoudabadi
Sina Hospital; Hasanabad square; Emam Khomeini street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 h.zabihi.dr@gmail.com Tehran University of Medical Sciences scientific Hossein Zabihi Mahmoudabadi
Sina Hospital; Hasanabad square; Emam Khomeini street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 h.zabihi.dr@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who are classified as mild or moderate cholecystitis according to the Tokyo 2018 guideline Referred to the emergency department of Sina and Amir Alam hospitals from the March 21th, 2019 to March 20th, 2021 Age over 18 years 18 years no limit Both Patients with Severe cholecystitis (grade III) Patients who have had abdominal pain for more than 5 days Patients who have been diagnosed with common bile duct stones during preoperative or postoperative examinations Patients diagnosed with cholangitis include patients with concomitant pancreatitis Cirrhotic patients Patients with hepatobiliary system cancers Patients with acquired or primary immunodeficiency Patients with antibiotic susceptibility to beta-lactams Patients with cholecystitis since diagnosis acute mild or moderate for them until surgery more than 48 interruptions Pregnant or lactating patients Patients who did not consent to participate in this study K81.0 Acute cholecystitis Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group (postoperative antibiotic therapy) are treated with oral antibiotics with ciprofloxacin 500 mg every 12 hours and metronidazole 250 mg every eight hours for up to 5 days after surgery. Patients who are unable to receive oral antibiotics will be treated with an intravenous antibiotic regimen including ceftriaxone, 1 g every 12 hours and metronidazole 500 mg every 8 hours until PO is completed. Control group: Patients with mild to moderate acute cholecystitis who do not receive post operative antibiotic treatment and are evaluated for surgical site infection rate and deep infection within the first 30 days after surgery. The rate of infection at the operation site. Timepoint: Up to 30 days after surgery(At the time of hospitalization daily and every two weeks thereafter). Method of measurement: Presence of purulent discharge from the wound, positive culture of wound discharge sampled by sterile method with one or more of the following symptoms: pain, tenderness, local swelling, warmth or redness of the wound. The diagnosis of SSI is made by the patient's professor or resident. The rate of deep infection. Timepoint: Up to 30 days after surgery (At the time of hospitalization daily and every two weeks thereafter). Method of measurement: Presence of purulent discharge from the wound, positive culture of wound discharge sampled by sterile method with one or more of the following symptoms: pain, tenderness, local swelling, warmth or redness of the wound. The diagnosis of SSI is made by the patient's professor or resident. Tehran University of Medical Sciences Approved 2019-03-21 Ethics Committee of Tehran University of Medical Sciences Sina Hospital, Hasanabad square, Emam Khomeini street Tehran Tehran Iran (Islamic Republic of)