Protocol summary
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Study aim
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Determining and comparing the efficacy of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients
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Design
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It is a randomized clinical trial study with a control group in a single-blind manner on 122 patients in 2 groups.
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Settings and conduct
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Patients who had a protective ileostomy (loop) installed in Sinai Hospital due to rectal cancer from 1402 to 1403 were randomly divided into one of 2 groups: loperamide, loperamide and diphenoxylate. become
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Participants/Inclusion and exclusion criteria
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Determining and comparing the efficacy of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients
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Intervention groups
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Patients will be randomly divided into 2 groups, and one group will receive loperamide. loperamide was started at 6 mg/day and increased daily by increments of 2-4 mg/day based on output and patient response, up to a maximum of 16 mg/day. In the Combination Group, loperamide (starting at 6 mg/day; maximum 16 mg/day) was administered alongside diphenoxylate, which was initiated at 5 mg/day and increased daily by 5 mg/day to a maximum of 20 mg/day
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Main outcome variables
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Ileostomy output ≤ 1500 g/day
General information
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Reason for update
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The primary reason for this update is that participant recruitment has now been completed. As the trial has concluded, we are updating the IRCT record to reflect the precise intervention details and study implementation. This includes correcting the description of intervention arms, adjusting the recruitment period to its actual duration, and updating the blinding status to accurately reflect the conducted trial. These updates are being made to ensure full transparency and alignment with the finalized protocol.
The original sample size of 40 participants was determined based on initial feasibility estimates and limited preliminary data. However, as the study progressed, interim observations and variability in patient outcomes indicated that a larger sample would be necessary to ensure adequate statistical power to detect clinically meaningful differences between the two intervention groups. Additionally, patient recruitment was slower than anticipated due to periodic disruptions in surgical scheduling and variability in postoperative ileostomy output among referred patients. As a result, the recruitment period was extended to allow for the inclusion of a sufficient number of eligible participants, ultimately improving the robustness and generalizability of the study findings. The final sample size was increased to a total of n=120 patients, with an equal allocation ratio, while adhering strictly to the original inclusion and exclusion criteria and maintaining full protocol compliance throughout.
Blinding status updated from single-blinded to open-label.
Initially, the study was planned to be single-blinded, with the intention of blinding participants to group allocation. However, as the trial was being planned, it became evident that due to the difference in medication regimens — with one group receiving a single agent (loperamide) and the other receiving a combination of loperamide and diphenoxylate-atropine — maintaining blinding was not practically feasible. The number and type of medications taken differed between groups, and matched placebos were not available to conceal treatment allocation. Therefore, the study was conducted as an open-label trial to ensure practical implementation while maintaining methodological rigor.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220530055031N4
Registration date:
2023-10-21, 1402/07/29
Registration timing:
prospective
Last update:
2025-04-17, 1404/01/28
Update count:
1
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Registration date
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2023-10-21, 1402/07/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-22, 1402/09/01
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Expected recruitment end date
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2025-02-19, 1403/12/01
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Actual recruitment start date
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2023-11-22, 1402/09/01
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Actual recruitment end date
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2025-02-19, 1403/12/01
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Trial completion date
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2025-03-10, 1403/12/20
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Scientific title
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Comparing the effectiveness of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in ۱۴۰۲-۱۴۰۳
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Public title
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Comparing the effectiveness of Loperamide and Diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in 1402-1403
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who underwent surgery due to rectal cancer and protective ileostomy were installed
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
Actual sample size reached:
122
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-10-11, 1404/07/19
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.371
Health conditions studied
1
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Description of health condition studied
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Output of ileostomy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Ileostomy output
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Timepoint
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The second day to the sixth day after the operation every 24 hours
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Method of measurement
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The output of the ostoma is collected in plastic containers with appropriate labels provided by the department
Secondary outcomes
1
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Description
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Drug complication
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Timepoint
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Within 5 days of starting the drug
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Method of measurement
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Expert opinion
Intervention groups
1
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Description
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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).
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Category
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Treatment - Drugs
2
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Description
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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).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The entire data will be shared after unidentifying people personal data
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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In order to perform further research with the request from the scientific institute
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From where data/document is obtainable
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Dear applicants will be referred to Sina Hospital's scientific Center for access to Documents and Data or the applicant can email the project executor. the email address is available. (amiratashi@sina.tums.ac.ir)
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What processes are involved for a request to access data/document
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After receiving the letter from the project executor, the applicant can refer to Sina Hospital Research Center and after the approval of the executor, the documents and data will be available to the executor within a week or the applicant can email directly to the project executor so the executor provide the information
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Comments
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