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IRCT20221230056987N1 IRCT 2023-05-09 Birjand University of Medical Sciences Evaluation of the relation between prophylactic antibiotics and prevalence of surgical site infection in elective laparoscopic cholecystectomy in low-risk patients Evaluation of the relation between prophylactic antibiotics and prevalence of surgical site infection in elective laparoscopic cholecystectomy in low-risk patients 2022-06-22 anticipated 122 Complete https://irct.ir/trial/69377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Intervention and Observation groups (A and B respectively) will be randomized in a block-to-block fashion, In which four block of 4 (AABB) is designed and randomly put after another until the designated sample size is reached. the aforementioned pattern will be used to distribute patients into a respected group, Blinding description: This study will be a double-blinded intervention so that the patient and the surgical team (residents and attending in charge of the patient) will not know about the allocation of the groups. 3 Condition 1: Symptomatic Cholelithiasis. Condition 2: Gallbladder Polyp. Condition 3: Chronic Cholecyctitis. Condition 4: Gallstone pancreatitis. Intervention 1: Intervention group: Patients in this group will receive prophylaxis in the form of one gram of intravenous cefazolin before surgical incision. All patients will be subjected to classic laparoscopic cholecystectomy in the 4-port method under direct supervision or by the university attendant at the educational center of Imam Reza Hospital. The preparation of the operation site will be performed according to the instructions of the operating room of Imam Reza (AS) hospital and with 10% iodine solution. Gallbladder will be removed directly without using endobag through epigastric port. The duration of the operation, the opening of the gallbladder or bleeding from the bed and the insertion of the catheter during the operation will be recorded for each patient. After the operation, the patients will be discharged with or without a drain and according to the opinion of the concerned doctor, until the significant recovery of pain and diet tolerance, and if there is no fever and the wound is clean. Intervention 2: Control group: patients in this group will not receive antibiotics before surgery and will instead receive a serum that does not contain antibiotics (placebo). All patients will be subjected to classic laparoscopic cholecystectomy in the 4-port method under direct supervision or by the university attendant at the educational center of Imam Reza Hospital. The preparation of the operation site will be performed according to the instructions of the operating room of Imam Reza (AS) hospital and with 10% iodine solution. Gallbladder will be removed directly without using endobag through epigastric port. The duration of the operation, the opening of the gallbladder or bleeding from the bed and the insertion of the catheter during the operation will be recorded for each patient. After the operation, the patients will be discharged with or without a drain and according to the opinion of the concerned doctor, until the significant recovery of pain and diet tolerance, and if there is no fever and the wound is clean. Yes - There is a plan to make this available What will be shared: All data will be made available in the form of SPSS files upon request When: The access period starts after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Overall evaluation of the research, re-analysis of the data, use of the data for further studies Where to obtain: Electronic correspondence with the researcher, Dr. Ali Najafi Semnani, through the following email address Sirius.ali@gmailcom How to obtain: Sending an email to the address provided and receive a response within 5 working days Comments:
public Ali Nadjafi-Semnani
East Saidi St., No. 14, Unit 8
Birjand Iran (Islamic Republic of) 9713664679 +98 56 3222 9129 Sirius.ali@gmail.com Birjand University of Medical Sciences scientific Ali Nadjafi-Semnani
East Saidi St., No. 14, Unit 8
Birjand Iran (Islamic Republic of) 9713664679 +98 56 3222 9129 Sirius.ali@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Symptomatic Cholelithiasis Gallbladder polyps Chronic cholecystitis Hx of Biliary Pancreatitis 18 years no limit Both Breast Feeding mothers Allergy to Cephalosporins Hx of Chemotherapy Hx of CKD or Chronic Liver Diseases Diabetes Regular Steroid Consumption Acute Cholecyctitis Hx of Antibiotic consumption 5 days prior to intervention K80 K87 K80.10 K85.1 Cholelithiasis Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere Calculus of gallbladder with chronic cholecystitis without obstruction Biliary acute pancreatitis Treatment - Drugs Placebo Intervention group: Patients in this group will receive prophylaxis in the form of one gram of intravenous cefazolin before surgical incision. All patients will be subjected to classic laparoscopic cholecystectomy in the 4-port method under direct supervision or by the university attendant at the educational center of Imam Reza Hospital. The preparation of the operation site will be performed according to the instructions of the operating room of Imam Reza (AS) hospital and with 10% iodine solution. Gallbladder will be removed directly without using endobag through epigastric port. The duration of the operation, the opening of the gallbladder or bleeding from the bed and the insertion of the catheter during the operation will be recorded for each patient. After the operation, the patients will be discharged with or without a drain and according to the opinion of the concerned doctor, until the significant recovery of pain and diet tolerance, and if there is no fever and the wound is clean. Control group: patients in this group will not receive antibiotics before surgery and will instead receive a serum that does not contain antibiotics (placebo). All patients will be subjected to classic laparoscopic cholecystectomy in the 4-port method under direct supervision or by the university attendant at the educational center of Imam Reza Hospital. The preparation of the operation site will be performed according to the instructions of the operating room of Imam Reza (AS) hospital and with 10% iodine solution. Gallbladder will be removed directly without using endobag through epigastric port. The duration of the operation, the opening of the gallbladder or bleeding from the bed and the insertion of the catheter during the operation will be recorded for each patient. After the operation, the patients will be discharged with or without a drain and according to the opinion of the concerned doctor, until the significant recovery of pain and diet tolerance, and if there is no fever and the wound is clean. Surgical site infection, superficial*. Timepoint: 7 days after the operation. Method of measurement: Diagnosis of superficial surgical site infection according to the physician's opinion and based on clinical or paraclinical findings. Surgical site infection, deep*. Timepoint: 7 days after the operation. Method of measurement: Diagnosis of deep surgical site infection according to the physician's opinion and based on clinical or paraclinical findings. Surgical site infection, Intra abdominal*. Timepoint: 7 days after the operation. Method of measurement: Diagnosis of intra abdominal surgical site infection according to the physician's opinion and based on clinical or paraclinical findings. Birjand University of Medical Sciences Approved 2023-03-06 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences, Ghafari Street, Birjand, South Khorasan, Iran Birjand South Khorasan Iran (Islamic Republic of)