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IRCT20200301046655N3 IRCT 2023-08-18 Tehran University of Medical Sciences Investigating the effect of glutamine in colorectal surgery Evaluation the effect of glutamine supplementation on inflammatory markers, surgical stress, carcinoembryonic antigen and postoperative outcomes in patients undergoing colorectal cancer surgery: a double-blind clinical trial study 2023-07-27 anticipated 200 Complete https://irct.ir/trial/71605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this experiment, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 200 people in the form of 50 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to carry out this trial correctly, a random allocation list will be produced separately for each of the two classes of body mass index 18.5 to 25 and 25 to 30, Blinding description: One of the nurses will be responsible for randomly selecting patients and prescribing supplements for them. In order to carry out this research blindly, the supplements will be completely similar and closed in terms of appearance. Also, glutamine supplement and placebo are separated by a specific code from the company, which will be determined after analyzing the results of the code for each group. Researchers and doctors will not know about the studied groups and the type of supplement prescribed. 3 Colorectal cancer. Intervention 1: Intervention group: They will receive glutamine powder (Karen Company) in the form of 30 grams per day for 10 days before surgery. Intervention 2: Control group: They will receive placebo with starch content (Karen Company) for 10 days before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences scientific Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) classification ≤ III Body mass index 18.5-30 Candidate for elective colorectal surgery 18 years no limit Both Absence of severe hepatic impairment Absence of renal impairment C18.9 Malignant neoplasm of colon, unspecified Prevention Prevention Intervention group: They will receive glutamine powder (Karen Company) in the form of 30 grams per day for 10 days before surgery. Control group: They will receive placebo with starch content (Karen Company) for 10 days before surgery. Carcinoembryonic antigen. Timepoint: At the beginning of the study (10 days before surgery), and one month after surgery. Method of measurement: Quantitative electroluminescence. Interleukin 6. Timepoint: At the beginning of the study (10 days before surgery), 12 hours before surgery and 48 hours after surgery. Method of measurement: Elisa method test. Neutrophil to lymphocyte ratio. Timepoint: At the beginning of the study (10 days before surgery), 12 hours before surgery and 48 hours after surgery. Method of measurement: The ratio of blood neutrophils to blood lymphocytes. Complications after surgery. Timepoint: During the first month after surgery. Method of measurement: Classification of complications based on Clavin-Dindo criteria. Average ratio of lymphocytes to monocytes. Timepoint: At the beginning of the study (10 days before surgery), 12 hours before surgery and 48 hours after surgery. Method of measurement: The ratio of lymphocyte to monocyte. Reactive protein c. Timepoint: At the beginning of the study (10 days before surgery), 12 hours before surgery and 48 hours after surgery. Method of measurement: Immunoturbidometry method. Tehran University of Medical Sciences Approved 2023-06-14 Research Ethics committee of Sina Hospital Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)