Evaluating the efficacy of ursodeoxycholic acid therapy in patients with acute cholecystitis who are candidates for delayed cholecystectomy in Ayatollah Mousavi Hospital in Zanjan

Evaluation of the effect of ursodeoxycholic acid in reducing pain in patients with acute cholecystitis who are candidates for delayed cholecystectomy

The study will be divided into two groups ( intervention and control). Each group's size will be 30 patients—randomization will be done by statistical software with the random blocks method. The study is a phase 3 clinical trial that will be performed on 60 patients.

Patients admitted to Ayatollah Mousavi Hospital in Zanjan after being diagnosed with cholecystitis and candidate for delayed cholecystectomy, will be divided into two groups. Prescription drugs will be different for patients. Data on the patient's pain will be collected with a Visual Analog Scale.

Inclusion criteria: Patient with a diagnosis of acute cholecystitis and a candidate for delayed surgery (patients who did not present in the first 72 hours of the disease, medical problems such as severe chronic heart failure). Stone size less than 15 mm, patients with mild symptoms or asymptomatic. Exclusion criteria: Patients who are unable to tolerate ursodeoxycholic acid, patients who become candidates for emergency or elective surgery before the sixth week during the prevention period. Age under 18 years, patients with moderate to severe symptoms, patients with complicated and complicated gallstones, patients with jaundice, patients with accompanying cholangitis, patients with impaired liver tests

Patients with acute cholecystitis who are candidates for delayed surgery are included in the study. Treatment will be performed in two groups with ursodeoxycholic acid and placebo.

Pain

A randomized block is used to randomize the patients under study and to fully observe the randomness of placement in the control group and the sample group because the inclusion process requires randomization due to the ongoing recruitment. Based on the calculated sample size, the sample size in each group is 24 people for easier application of random blocks to randomize the members of each group. Permutations are considered as 6 permutations according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The permutations are written on 6 cards and the selection of permutations and their order will be randomly selected from among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. An individual randomization unit will be used for the study. The information of the registered persons will be anonymous and without their personal information.