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
Design
It is a randomized clinical trial study with a control group in a single-blind manner on 40 patients in 2 groups.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
Determining and comparing the efficacy of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients
Intervention groups
Patients will be randomly divided into 2 groups, and one group of patients will receive loperamide at a dose of 2 mg three times a day every 8 hours, the second group will receive loperamide at a dose of 2 mg twice a day every 12 hours along with diphenoxylate at a dose of 2 They receive 5 mg twice a day every 12 hours
Main outcome variables
Ileostomy output
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220530055031N4
Registration date:2023-10-21, 1402/07/29
Registration timing:prospective
Last update:2023-10-21, 1402/07/29
Update count:1
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Seyed Amir Miratashi Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
amiratashi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of loperamide and diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in ۱۴۰۲-۱۴۰۳
Public title
Comparing the effectiveness of Loperamide and Diphenoxylate in controlling the output of protective ileostomy in rectal cancer patients in Sinai Hospital in 1402-1403
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 20 participants in each group (40 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.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants do not know about being in two study groups, and the treatment is done for the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical faculty of Tehran University of Medical Sciences
Street address
Room 604, 6th floor, Tehran University of Medical Sciences Central Building, Keshavarz Blvd., Qods St. intersection
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2025-10-11, 1404/07/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.371
Health conditions studied
1
Description of health condition studied
Output of ileostomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ileostomy output
Timepoint
The second day to the fifth 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
Secondary outcomes
1
Description
Drug complication
Timepoint
Within 5 days of starting the drug
Method of measurement
Expert opinion
Intervention groups
1
Description
Intervention group: Intervention group: In this group, after ileostomy operation, they receive loperamide at a dose of 2 mg twice a day every 12 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 three times a day every 8 hours along with diphenoxylate at a dose of 2.5 mg three times a day every 8 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 6 hours, three times a day with an interval of 4 hours, and four times a day with an interval of 4 hours). 3 hours).
Category
Treatment - Drugs
2
Description
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).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Seyed Amir Miratashi
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Research and Technology Vice-Chancellor, 6th floor, Central Organization of the University, Keshavarz Blvd., corner of Quds St.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi Yazdi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran, Iran, and Po BOX: 1136746911
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
amiratashi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi Yazdi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran, Iran, and Po BOX: 1136746911
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
amiratashi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi Yazdi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue, Tehran, Iran, and Po BOX: 1136746911
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
amiratashi@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The entire data will be shared after unidentifying people personal data
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to perform further research with the request from the scientific institute
From where data/document is obtainable
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)
What processes are involved for a request to access data/document
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