Comparing the effectiveness of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in ۱۴۰۲-۱۴۰۳

Determining and comparing the efficacy of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients

It is a randomized clinical trial study with a control group in a single-blind manner on 122 patients in 2 groups.

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

Determining and comparing the efficacy of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients

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

Ileostomy output ≤ 1500 g/day

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.

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.

The entire data will be shared after unidentifying people personal data

6 months after publishing the results

Researchers working in academic and scientific institutions

In order to perform further research with the request from the scientific institute

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)

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