Effect of adding egg lotion to routine treatment of solitary rectal ulcer.
Design
After receiving patients' consent and confirmation of existence of solitary rectal ulcer, patients are randomly assigned to two groups of 30 people.The randomization method is that envelopes containing drugs are provided and numbered by an individual outside the study based on a random allocation table. Then these envelopes are handed to patients in turn.
Settings and conduct
This is a double-blinded clinical trial in which researcher and patient are unaware of the type of intervention and is carried out on 60 patients with solitary rectal ulcer in Ghaem Hospital of Mashhad. Participants are randomly divided into intervention and control groups. Both groups are advised to use fiber for soft stools. Outpatient treatment is done for 7 days. Patients are examined every two days during treatment. After completing the course of treatment, patients are followed up monthly for a period of three months. After the three-month period, recto-sigmoidoscopy is carried out for confirmation or rejection of complete SRU improvement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with rectology who are confirmed to have solitary rectal ulcer throught recto-sigmoidoscopy.
Intervention groups
Intervention group: In addition to sucralfate enema, anti solitary rectal ulcer egg lotion is prescribed.
Control group: sucralfate enema is prescribed.
Main outcome variables
rate of improvement of solitary rectal ulcer, rate of hemorrhage improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140824018915N7
Registration date:2018-05-21, 1397/02/31
Registration timing:registered_while_recruiting
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-12, 1396/11/23
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of egg lotion on treatment of SRU
Public title
Evaluation of the effect of egg lotion on treatment of solitary rectal ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rectology who are confirmed to have solitary rectal ulcer throught recto-sigmoidoscopy
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method is that envelopes containing drugs are provided and numbered by an individual outside the study based on a random allocation table. Then these envelopes are handed to patients in turn.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study in which researcher and patient are unaware of the type of intervention which means researcher and patient have no knowledge of the content of the envelope and treatment method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.442
Health conditions studied
1
Description of health condition studied
Solitary rectal ulcer syndrome
ICD-10 code
K62.6
ICD-10 code description
Ulcer of anus and rectum
Primary outcomes
1
Description
rate of improvement of solitary rectal ulcer
Timepoint
Patients are under treatment for 7 days. They are examined every two days during treatment period. After completing the course of treatment, patients are followed up monthly for three months. After the three month period, recto-sigmoidoscopy is carried out.
Method of measurement
use of recto-sigmoidoscopy for confirmation or rejection of complete improvement of the SRU
2
Description
rate of hemorrhage improvement
Timepoint
Patients are under treatment for 7 days. They are examined every two days during treatment period. After completing the course of treatment, patients are followed up monthly for three months. After the three month period, recto-sigmoidoscopy is carried out.
Method of measurement
Clinical examination and recto-sigmoidoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to sucralfate enema, anti solitary rectal ulcer egg lotion is prescribed.
Category
Treatment - Drugs
2
Description
Control group: sucralfate enema is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Mousalreza Hoseini
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Email
hoseinimr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Dadellahi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
Dadelahif901@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In case organizations ask for the data of participants, the data will become accessible for them.
When the data will become available and for how long
The data can be accessible for specific organization request 6 month after the article is published.
To whom data/document is available
All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures.
Under which criteria data/document could be used
In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months.