The main goal of this study is to compare two alternative treatment options for chronic constipation, namely water enema and common medical therapy. A comparison will be conducted on the level of symptoms alleviation, such as the frequency of bleeding or the pain severity, and the perceived improvement in quality of life. Analysing the results of this study will enable the clinicians to select a more appropriate strategy for treating chronic constipation and to improve the patients’ overall quality of life.
Design
This will be an un blinded clinical trial, randomized by application of the sealed envelope method. It will have parallel design including a control group. This clinical trial will have a sample size of at least 60 patients.
Settings and conduct
The cases of chronic constipation which are referred to the Bojnourd hospitals during the defined interval will be enrolled in our study. Opportunistic sampling and randomization via sealed envelope method will be carried out.
Participants/Inclusion and exclusion criteria
The presence of chronic constipation ( having two or fewer defecations per week)
Intervention groups
The first group consists of patients who are treated with water enema ( 150 to 200 milliliter of water). Patients in second group undergo medical therapy with MgOH syrup and Bisacodyl Suppositories.
Main outcome variables
Alleviation of symptoms associated with chronic constipation (such as pain severity and frequency of bleeding)/ increase in the number of defecations in each week will be compared among the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049547N1
Registration date:2021-12-06, 1400/09/15
Registration timing:registered_while_recruiting
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Mohsen Rakhsha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 3012
Email address
sadafdelshad.98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Water Enema with common medical therapy in alleviating Constipation in Chronic Constipation patients
Public title
Effects of Water Enema on Chronic Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients suffering from signs of chronic constipation ( two or fewer defecations in a week )can be included in the study
Exclusion criteria:
Age
From 15 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be carried out using the “sealed envelope method” . Every participating clinician are provided with an identical set of envelopes which contain either of the two treatment options. Each of the two options have the same in the number in the sets. Each clinician would draw one envelope from the set for each patient and continue the patient’s treatment according to the drawn result.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
North Khorasan University of Medical Sciences; Shahriar St; Bojnurd; North Khorasan Province
City
Bojnurd
Province
North Khorasan
Postal code
9413875199
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.NKUMS.REC.1399.062
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
ME05.0
ICD-10 code description
Constipation is an acute or chronic condition in which bowel movements occur less often than usual or consist of hard, dry stools that are often painful or difficult to pass. Here constipation other than specifically described elsewhere such as in here.
Primary outcomes
1
Description
An increase in the number of defecations : more than two defecations per week
Timepoint
Three months and Six months after the intervention
Method of measurement
Patients’ Inquiry regarding the number of defecations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Water Enema recipients Patients will enema 150 to 200 cc of water through the anus daily with Powar. During the 6-month study period, the patient is advised to use only the treatment provided.
Category
Treatment - Devices
2
Description
Control group: The control group will use the usual treatment for patients with constipation, which includes drug treatment (30 cc of Magnesium Hydroxide syrup every 12 hours and daily Bisacodyl suppository).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Mohsen Rakhsha
Street address
No. 86, kallantari Ave., East Talleghani, Bojnurd,
City
Bojnurd
Province
North Khorasan
Postal code
9415643344
Phone
+98 58 3229 6769
Fax
+98 58 3229 6764
Email
dr.rakhsha@yahoo.com
Web page address
http://nkums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohsen Rakhsha
Street address
No. 86, kallantari11 Ave., East Talleghani., Bojnurd,
City
Bojnurd
Province
North Khorasan
Postal code
9415643344
Phone
+98 58 3229 6769
Fax
+98 58 3229 6764
Email
m.rakhsha@nkums.ac.ir
Web page address
http://nkums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mohsen Rakhsha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. Shahriar6 Ave., Alghadir, Bojnurd,
City
Bojnurd
Province
North Khorasan
Postal code
9415643344
Phone
+98 912 126 1128
Email
dr.rakhsha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hamid Reza Shoraka
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Vector - Borne Research center- Shahriar St
City
Bojnurd
Province
North Khorasan
Postal code
941236542
Phone
+98 58 3229 7182
Email
hamidrezashoraka@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohsen Rakhsha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No.86, Kallantary Ave., East Kallantary., Bojnurd.
City
Bojnurd
Province
North Khorasan
Postal code
941236542
Phone
+98 912 126 1128
Email
dr.rakhsha@yahoo.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
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
All personal data is shared after deleting the profile
When the data will become available and for how long
Access period starts 9 months after the results are published
To whom data/document is available
Researchers working in academic institutions and public and private scientific research centers
Under which criteria data/document could be used
Any analysis and use of this data is permitted.
From where data/document is obtainable
dr.rakhsha@yahoo.com
What processes are involved for a request to access data/document
Obtaining the permit of the deputy of research and technology of North Khorasan University of Medical Sciences.