Effect of prophylactic antibiotics before intraureteral lithotripsy on infection and inflammatory factors

Effect of prophylactic antibiotics before intraureteral lithotripsy on infection and inflammatory factors

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. The rand function of Excel software was used for randomization.

In this double-blind clinical trial study, all non-febrile hospitalized patients with ureteral stones with negative preoperative culture in Shahid Beheshti Hospital of Babol are included in the study.One hour before surgery, the first group (intervention group) is given an intravenous dose of cefazolin 1gr (from the pharmaceutical company Aria). To the second group (control group) 1 hour before surgery, placebo, which is normal saline serum, is given. The placebo will be designed similar to cefazolin. After selecting and randomizing, patients will be divided into a and b groups. The participants and those who will evaluate outcome, will not be informed how to patients allocated in groups.

Inclusion criteria: All non-febrile hospitalized patients with ureteral stones with negative preoperative culture are included in the study. Exclusion criteria: age older than 65 years, heavy smoking, chronic steroid use, immunodeficiency

For the case group, 1 gram of cefazolin antibiotic is used one hour before the operation, and for the control group and for the control group, 1 hour before the operation, a placebo, which is normal saline, is given.

Infection, Fever

After applying the entry and exit criteria, subjects will be randomly assigned using permutation blocks. By using Sealedenvelop.com software, a sequence of size 80 will be produced. The randomization unit is an individual. The size of the blocks is 4 and in each block each intervention group will be repeated twice (the randomization ratio in each block is 1:1). Using this randomly generated list, the participants are assigned to one of the two study groups. In order to hide the list of random allocation, a special code will be assigned to each of the intervention groups, which even the main implementer of the project (supervisor) is not aware of. These codes are written on a paper and placed inside a sealed envelope. A unique code specific to each patient will be written on this paper and its envelope. All envelopes will be placed in a larger box in random order and sealed in the box. The main researcher, after reviewing the criteria for entering the study and obtaining informed consent, as well as registering the patient's profile in a special form, in collaboration with the random allocation list (this person is an expert, other than the main researcher, who is involved in the patient recruitment process and sample entry) is called and randomization of that patient is done.

After selection and randomization, patients will be divided into groups a and b. The form of the drugs is completely the same, so the patient will not know the type of intervention. The participants and those who will assess the outcome will not know how the patients are arranged in the groups. Therefore, the study will be conducted in a double-blind manner.

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