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IRCT20220530055031N4 IRCT 2023-10-21 Tehran University of Medical Sciences Comparing the effectiveness of Loperamide and Diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in 1402-1403 Comparing the effectiveness of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in ۱۴۰۲-۱۴۰۳ 2023-11-22 anticipated 120 Complete https://irct.ir/trial/73148 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into one of 2 groups: loperamide, loperamide and diphenoxylate. Block randomization with different block sizes is used to randomly assign two groups with 60 participants in each group (120 patients in total). The size of the blocks is a multiple of 2 and the divisor is 20. Initially, the block sizes are chosen randomly. Then, for each block, different permutations are determined for equal group size. Finally, one of the permutations is randomly selected and random numbers are generated using a computer in an independent statistical unit. N/A Output of ileostomy. Intervention 1: Intervention group: Intervention group: In this group, after ileostomy operation, they receive loperamide at a dose of 2 mg three times a day every 8 hours along with diphenoxylate at a dose of 2.5 mg twice a day every 12 hours. On the next day, if he does not respond to the treatment, loperamide at a dose of 2 mg four times a day every 6 hours along with diphenoxylate at a dose of 2.5 mg 4 times a day every 6 hours. Then loperamide at a dose of 4 mg three times a day every 8 hours along with diphenoxylate at a dose of 5 mg three times a day every 8 hours. Then loperamide at a dose of 4 mg four times a day every 6 hours along with diphenoxylate at a dose of 5 mg four times a day every 6 hours (maximum dose of loperamide 16 mg and maximum dose of diphenoxylate 20 mg). In this group of patients, loperamide and diphenoxylate are given to patients with maximum intervals (for example, twice a day with an interval of 12 hours, three times a day with an interval of 8 hours, and four times a day with an interval of 6 hours). Intervention 2: Control group: a group of patients who only receive routine treatment. Loperamide patients with a dose of 2 mg three times a day every 8 hours. On the next day, if he does not respond to the treatment, loperamide at a dose of 2 mg four times a day every 6 hours. Then loperamide at a dose of 4 mg three times a day every 8 hours. Then loperamide at a dose of 4 mg four times a day every 6 hours (maximum dose of loperamide 16 mg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Seyed Amir Miratashi Yazdi
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran, Iran, and Po BOX: 1136746911
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 amiratashi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Seyed Amir Miratashi Yazdi
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran, Iran, and Po BOX: 1136746911
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 amiratashi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who underwent surgery due to rectal cancer and protective ileostomy were installed 18 years no limit Both Patients who have a history of taking drugs that affect the function and motility of the digestive system within 2 weeks before the study Age below 18 years Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: In this group, after ileostomy operation, they receive loperamide at a dose of 2 mg three times a day every 8 hours along with diphenoxylate at a dose of 2.5 mg twice a day every 12 hours. On the next day, if he does not respond to the treatment, loperamide at a dose of 2 mg four times a day every 6 hours along with diphenoxylate at a dose of 2.5 mg 4 times a day every 6 hours. Then loperamide at a dose of 4 mg three times a day every 8 hours along with diphenoxylate at a dose of 5 mg three times a day every 8 hours. Then loperamide at a dose of 4 mg four times a day every 6 hours along with diphenoxylate at a dose of 5 mg four times a day every 6 hours (maximum dose of loperamide 16 mg and maximum dose of diphenoxylate 20 mg). In this group of patients, loperamide and diphenoxylate are given to patients with maximum intervals (for example, twice a day with an interval of 12 hours, three times a day with an interval of 8 hours, and four times a day with an interval of 6 hours). Control group: a group of patients who only receive routine treatment. Loperamide patients with a dose of 2 mg three times a day every 8 hours. On the next day, if he does not respond to the treatment, loperamide at a dose of 2 mg four times a day every 6 hours. Then loperamide at a dose of 4 mg three times a day every 8 hours. Then loperamide at a dose of 4 mg four times a day every 6 hours (maximum dose of loperamide 16 mg). Ileostomy output. Timepoint: The second day to the sixth day after the operation every 24 hours. Method of measurement: The output of the ostoma is collected in plastic containers with appropriate labels provided by the department. Drug complication. Timepoint: Within 5 days of starting the drug. Method of measurement: Expert opinion. Tehran University of Medical Sciences Approved 2025-10-11 Ethics committee of medical faculty of Tehran University of Medical Sciences Room 604, 6th floor, Tehran University of Medical Sciences Central Building, Keshavarz Blvd., Qods St. intersection Tehran Tehran Iran (Islamic Republic of)