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IRCT20221126056618N1 IRCT 2022-12-14 Tehran University of Medical Sciences Investigating the effect of biofeedback therapy on MR defecography indicators Investigating the effect of biofeedback therapy compared to standard treatment on MR defecography indicators in patients with obstructive excretory syndrome. 2023-01-21 anticipated 28 Complete https://irct.ir/trial/67077 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 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. N/A Obstructive Defecation syndrome. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 access period will start after the publication of the research articles To whom: All researchers interested in working in this field Conditions: 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. Where to obtain: To receive data, applicants can write to the email address hadavidorsa@gmail.com How to obtain: 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. Comments:
public Dorsa Hadavi
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ 0098 21 61190 hadavidorsa@gmail.com Tehran University of Medical Sciences scientific Dorsa Hadavi
Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ 0098 21 61190 hadavidorsa@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Suffering from chronic constipation based on history, clinical examinations and colon transit test and confirming the diagnosis of Obstructive Excretion Syndrome (ODS) 18 years 65 years Both Psychiatric disorders pregnancy breastfeeding Substance abuse K59.02 Outlet dysfunction constipation Treatment - Other Treatment - Other 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. 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. 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. Tehran University of Medical Sciences Approved 2022-11-15 Research Ethics Committee of Imam Khomeini Hospital Complex - Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Dr. Gharib Street, at the end of Keshavarz Boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)