Investigating the effect of biofeedback therapy compared to standard treatment on MR defecography indicators in patients with obstructive excretory syndrome.
Comparison the effect of biofeedback therapy versus standard treatment on Magnetic Resonance(MR)defecography indicators in patients with chronic constipation disorders.
Design
This study is a clinical trial with an intervention and control group conducted in a parallel and double-blind manner. The method of blinding will be in such a way that the subjects and the outcome evaluator will be unaware of the allocation of people to the intervention and control groups. Sample size There will be 14 people in each group and a total of 28 people. For randomization, the block randomization method is used.
Settings and conduct
This study conducted in a parallel and double-blind manner at Imam Khomeini Hospital. The method of blinding will be in such a way that the subjects and the outcome evaluator will be unaware of the allocation of people to the intervention and control groups.
Participants/Inclusion and exclusion criteria
All patients aged 18 to 65 with chronic constipation who have been diagnosed with Obstructive Defecation Syndrome (ODS) based on history, clinical examination and colon transit test will be included in the study. Pregnant and lactating people, and people with a history of substance abuse will not be included in the study.
Intervention groups
Intervention group: It includes people who underwent MR defecography and will be prescribed standard treatment along with biofeedback at the same time.
Control group: includes people who will be prescribed standard treatment including high-fiber diet, elimination training and laxative use
Main outcome variables
MR defecography indices before and after biofeedback
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056618N1
Registration date:2022-12-14, 1401/09/23
Registration timing:prospective
Last update:2022-12-14, 1401/09/23
Update count:0
Registration date
2022-12-14, 1401/09/23
Registrant information
Name
Dorsa Hadavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 0000
Email address
yousefkhani1984@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of biofeedback therapy compared to standard treatment on MR defecography indicators in patients with obstructive excretory syndrome.
Public title
Investigating the effect of biofeedback therapy on MR defecography indicators
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from chronic constipation based on history, clinical examinations and colon transit test and confirming the diagnosis of Obstructive Excretion Syndrome (ODS)
At first, 4 blocks of 4 were prepared in Excel software as (AA, BB), (BB, AA), (AB, BA), (BA, AB), (AB, AB), (BA, BA) and Then these blocks will be sorted from one to four. A was for the treatment or intervention group and B was for the control group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to treatment or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, so that the evaluator and the subject are not aware of the status of assigning people to the study groups. For the study subjects, before the random assignment, it is explained how the work process is.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.206
Health conditions studied
1
Description of health condition studied
Obstructive Defecation syndrome
ICD-10 code
K59.02
ICD-10 code description
Outlet dysfunction constipation
Primary outcomes
1
Description
MR defecography indicators in patients with obstructive syndrome
Timepoint
The examination of MR defecography indicators will be at the end of the third week after entering the study.
Method of measurement
Measurement and comparison of the results of the intervention will be done using MRI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It will include people who will be given standard treatment including high-fiber diet, training on bowel movement and laxative use along with biofeedback. Before doing biofeedback, it is necessary for the patient to have full knowledge of the functioning mechanism of the human body and know anorectal anatomy. The examination of the rectal bag is performed on the patient so that the patient gets familiar with the concept of contraction and expansion of the anal sphincter. The training method is side lying, which means that the patient is shown how the anal sphincter works with a bile duct pressure measurement catheter that enters the anal-rectum canal. With the doctor's explanation and guidance, the patient will be able to distinguish abnormal from normal images in this test and can perform the necessary procedures to increase intra-abdominal pressure and systolic pressure at the same time as the anal sphincter relaxes and repeat. The treatment protocol consists of 3 sessions per week and each session lasts for an hour, and each course consists of 8 sessions and will be accompanied by sessions to strengthen autonomous function at home.
Category
Treatment - Other
2
Description
Control group: The patients with diagnosis of Obstructive Defecation Syndrome(ODS) in Imam Khomeini Hospital who are waiting for biofeedback therapy and only receive standard constipation treatment including high fiber diet and using laxatives. These patients undergo MR defecography before and after standard treatment protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dorsa Hadavi
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 911 157 3462
Email
hadavidorsa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotouhi
Street address
Research and Technology Vice-Chancellor, 6th corner of Quds St, Organization of the University, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 8163 3698
Email
vcr@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
Dorsa Hadavi
Position
Radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 21 61190
Email
hadavidorsa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dorsa Hadavi
Position
Radiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 21 61190
Email
hadavidorsa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dorsa Hadavi
Position
Radiology residenti
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 21 61190
Email
hadavidorsa@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file of the participants, the study protocol, the informed consent form and the clinical study report will be provided to the interested researchers in compliance with the ethical standards, including non-identification of the patients and other such matters.
When the data will become available and for how long
The data access period will start after the publication of the research articles
To whom data/document is available
All researchers interested in working in this field
Under which criteria data/document could be used
The data of the study will be made available to interested parties for the purpose of secondary analysis or other relevant research purposes while maintaining the confidentiality of the participants.
From where data/document is obtainable
To receive data, applicants can write to the email address hadavidorsa@gmail.com
What processes are involved for a request to access data/document
After the correspondence by the applicants in order to receive the data of the study, after the necessary checks, the data will be provided to them within a week.