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IRCT20210602051484N1 IRCT 2021-08-10 Zanjan University of Medical Sciences The effectiveness of enoxaparin in preventing deep vein thrombosis Evaluation of the effectiveness of enoxaparin in preventing the occurrence of deep vein thrombosis in patients' candidates for laparoscopic cholecystectomy 2021-06-20 anticipated 200 Complete https://irct.ir/trial/56720 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples were selected from 200 patients admitted to the surgical wards of Ayatollah Mousavi Hospital affiliated to Zanjan University of Medical Sciences. The samples were divided into 100 subjects in the intervention group and 100 subjects in the control group by simple random method using coin toss. In coin tossing, if the coin image part came, the samples were in the intervention group and otherwise the samples were in the control group. Sampling was continued until the number of samples in each group was completed. 3 Deep vein thrombosis. Intervention 1: In the intervention group, in addition to routine treatments, injectable enoxaparin 4000 units, made by Alborz Drug Company, single dose, half an hour before surgery, in the operating room, will be injected subcutaneously for these patients. Intervention 2: Control group: will receive only routine treatments including daily dressings and antibiotics. Yes - There is a plan to make this available What will be shared: After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary). When: The start of the access period to the data of this study will be from Early 2022 and approximately 6 months after the publication of the results. To whom: The data of this study are possible for all patients with gallstones and surgical candida, and especially those working in health care systems. Conditions: The researcher wants to use the data to improve gallstone patients and candidates for surgery. Where to obtain: To receive information anyone can be use the following email: mohammadarbati@zums.ac.ir How to obtain: After sending the message and introducing herself or himself and the reason for the need for data, the applicant will be provided with the information after confirmation. Comments:
public Dr Mohammad Mohammadiarbati
Ayatollah Mousavi Hospital, Gavazang Street,Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 009833130000 mohammadarbati@zums.ac.ir Zanjan University of Medical Sciences scientific Dr Mohammad Mohammadiarbati
Ayatollah Mousavi hospital, Gavazang Street, Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 mohammadarbati@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study All patients under 70 years of age do not have coagulation disorders Not having underlying diseases associated with DVT All patients have symptomatic gallstones (abdominal pain, nausea and vomiting after eating) Simultaneous existence of gallbladder polyps and gallstones Diabetic people with gallstones Patients with asymptomatic gallstones who are unable to access equipped centers in the future. Patients who have not allergy to enoxaparin. Do not take anti-coagulant drugs no limit 70 years Both Patients with surgical indications with the possibility of absolute rest after surgery Patients with the possibility of complications such as postoperative bleeding I80.2 Phlebitis and thrombophlebitis of other deep vessels of lower extremities Prevention Prevention In the intervention group, in addition to routine treatments, injectable enoxaparin 4000 units, made by Alborz Drug Company, single dose, half an hour before surgery, in the operating room, will be injected subcutaneously for these patients. Control group: will receive only routine treatments including daily dressings and antibiotics. Not occurrence of deep vein thrombosis. Timepoint: The effectiveness of enoxaparin in 24 hours after injection, 72 hours after injection and 14 days after injection. Method of measurement: Presence or absence of deep vein thrombosis examination and follow-up with color Doppler ultrasound and entering its information in a checklist. Not occurrence of pulmonary embolism. Timepoint: The effectiveness of enoxaparin in 24 hours after injection, 72 hours after injection and 14 days after injection. Method of measurement: Presence or absence of pulmonary embolism by examination and follow-up with CT pulmonary angiography with venous contrast and entering its information in a checklist. Zanjan University of Medical Sciences Approved 2021-06-08 Ethics Committee of Deputy of Research and Technology of Zanjan University of Medical Sciences Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)