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IRCT20200710048071N1 IRCT 2020-08-16 Tehran University of Medical Sciences Efficacy of fibrine glue on seroma formation after lymph nodes D2 dissection TFD2 Efficacy of fibrine glue on seroma formation after lymph nodes D2 dissection in gastric cancer surgery 2020-06-30 anticipated 80 Complete https://irct.ir/trial/49823 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is generated using random block generation. The block size includes 4 and 2 block. 15 blocks with size of 4 and 10 blocks with size of 2 will be generated using a computer program. The blocks will be allocated using random numbers and the allocation was concealed from the patients, Blinding description: The study will be one-sided blind so that patients will be completely unaware of the randomization protocol and allocation. 3 Gastric cancer. Intervention 1: Intervention group:In this group, after D2 lymphatic dissection, 0.5 ml of fibrine glue (IFABOND, Peters Surgical,Bobigny,France) is injected into the dissected area, and seroma formation is measured within 24-hours after dissection until the patient's discharge. Measurement method is based on the amount of discharge in the surgical drain of the patient placed during the surgery. Intervention 2: Control group: In this group, after D2 lymphatic dissection, not the fibrin glue nor any tissue adhesive is injected into the dissected area. similar to the intervention group the examiner measured the amount of discharge in the surgical drain. Yes - There is a plan to make this available What will be shared: All research data except the patient profile can be published When: 6 months after printing the results To whom: Researchers working in academic institutions Conditions: To continue research on this topic Where to obtain: To the main and scientific person in charge of research How to obtain: The email sent will be checked and the requested content will be answered if it is correct Comments:
public Ehsanollah Rahimi Movaghar
No62.Rahimi St.Valiasr Ave.Tehran
Tehran Iran (Islamic Republic of) 1586899567 +98 21 2265 9074 ehsanrm81@gmail.com Tehran University of Medical Sciences scientific Ehsanollah Rahimi Movaghar
No62.Rahimi St.Valiasr Ave.Tehran
Tehran Iran (Islamic Republic of) 1586899567 +98 21 2265 9074 ehsanrm81@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with gastric cancer are candidates for gastrectomy,hospitalized in 1399 18 years no limit Both Patients with a history of surgery, patients with dissatisfaction with the study, patients with any local allergy to fibrin glue, patients in the metastatic stage of cancer C16 Malignant neoplasm of stomach Treatment - Drugs Treatment - Drugs Intervention group:In this group, after D2 lymphatic dissection, 0.5 ml of fibrine glue (IFABOND, Peters Surgical,Bobigny,France) is injected into the dissected area, and seroma formation is measured within 24-hours after dissection until the patient's discharge. Measurement method is based on the amount of discharge in the surgical drain of the patient placed during the surgery. Control group: In this group, after D2 lymphatic dissection, not the fibrin glue nor any tissue adhesive is injected into the dissected area. similar to the intervention group the examiner measured the amount of discharge in the surgical drain. Seroma formation. Timepoint: Measurement of drainage (seroma) on a daily basis until discharge of patients. Method of measurement: Drain rate (ml / 24 hours). Number of days hospitalized. Timepoint: Duration of hospitalization. Method of measurement: Days of hospitalization. Tehran University of Medical Sciences Approved 2020-06-30 Ethics committe Imam Khomeini hospital complex-Tehran university of medical sciences No.62 Rahimi st,Valiasr blvd,Tehran Tehran Tehran Iran (Islamic Republic of)