The effect of colon washing and conditioning with low pressured irrigator in treatment of chronic constipation and secondary hemorrhoid on women aged 20-40 years
The purpose this clinical trial study is to determine the therapeutic effectiveness of colon washing and its conditional by irrigator (designed by researchers and made by the Dourika factory) with a low pressure (2.5-5 PSI) in the secondary constipation and hemorrhoids in women aged 40 - 20 years. 40 patients with chronic constipation and secondary hemorrhoid, from 22 Bahman hospital, will be randomly assigned into intervention or control group. The intervention group was received a six months colon washing with irrigator but the control group will receive conventional treatment method. Constipation, hemorrhoids, and conditioning parts will be measured through a three points rating scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904074263N1
Registration date:2010-09-14, 1389/06/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-14, 1389/06/23
Registrant information
Name
Jahanshir Tavakolizadeh
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3725 5335
Email address
dr.tavakolizadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Education and Research, Gonabad University Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of colon washing and conditioning with low pressured irrigator in treatment of chronic constipation and secondary hemorrhoid on women aged 20-40 years
Public title
Treatment of chronic constipation and hemorrhoid with colon washing and its conditioning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: To be women and have been between 40-20 years old . –inclusion criteria of samples for chronic constipation have been done according to criteria in Table 2.
inclusion criteria of hemorrhoid: Any hemorrhoid accompanied by constipation and it has been secondary.
Table 1: Rome II criteria for chronic constipation (derived from Johnson KralStein, 2007)
The presence of 2 or more of the following for at least 3 months, which need not be consecutive, in the past 12 months *:
- straining during more than 25% of defecations
- Lumpy or hard stool more than 25% of defecations
- Sensation of incomplete evacuation more than 25% of of defecations
- Sensation of anorectal obstruction / lockade more than 25% of defecations.
- Manual maneuvers to facilitate more than 25% of defecations
- Less than three defecations per week
* loose stools not present, and criteria are insufficient for irritable bowel Syndrome . The Table from Johanson and Kralstein (2007) 22.
Table 2 Rome III criteria for functional constipation:
-Two or more of the following for the last 3 months:
- straining during at least 25% of defecations
- hard or Lumpy stools in at least 25% of defecations
- Sensation of incomplete evacuation in at least 25% of defecations
- Sense of anorectal obstruction in at least 25% of defecations.
- Manual maneuvers to facilitate in at least 25% of defecations
- Less than 3 bowel movements per week
- loose stools are rarely present without the use of laxatives. criteria for irritable bowel Syndrome are not fullfilled
The table derived from Choung, et al, 2007)
Exclusion criteria:
- no pregnant
– the history of cancer disease or other organic diseases ( by physician diagnosis), such as (diverticulosis, inflammatory bowel disease, IBD and irritable bowel syndrome, IBS-C), by taking the observation from patient and examination by surgeon general is rule out.
- the history of pathologies such as tumors of the colon area, that led to hemorrhoid are rejected,
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences , Sento road
City
Gonabad
Postal code
Approval date
2010-08-21, 1389/05/30
Ethics committee reference number
2-30-5-1389
Health conditions studied
1
Description of health condition studied
Chronic constipation and secondary hemorrhoid
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chronic constipation
Timepoint
6 months
Method of measurement
A rating scale
2
Description
Secondry hemorhoid
Timepoint
6 months
Method of measurement
A rating scale
3
Description
Ordely defecation
Timepoint
6 months
Method of measurement
A rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Colon washing by irregator (Duration: 1-3 months, how to use of Irregator: with teaching by a psychologist and a physician)
Category
Treatment - Other
2
Description
Conditioning (duration 1-6 months, how to use: with doing colon washing precisely and orderly by Irregator at special time)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Dr Shirin Torabi, Assistant professor
Street address
Women clinic-22 Bahman hospital- Naser Khosro street
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drputy for Education and Research, Gonabad University of Medical Sciences
Full name of responsible person
Dr Kianmehr
Street address
Drputy for Education and Research, Gonabad University of Medical Sciences , Cento road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drputy for Education and Research, Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Mohammadpour
Position
Research manager, Assistant Professor
Other areas of specialty/work
Street address
Deputy for Education and Research, Gonabad University of Medical Sciences, Cento road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
amohammadpur@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Jahanshir Tavakolizadeh
Position
Assistant professor
Other areas of specialty/work
Street address
The board of basic science-Deputy for Education and Research, Gonabad University Medical Sciences, Cento road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
jahanshir_t@yahoo.com.au
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mr Ali Ekrami
Position
Research expert
Other areas of specialty/work
Street address
Research managemete- Deputy for Education and Research, Gonabad University of Medical Sciences, Cento road
City
Goabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)