Protocol summary

Summary
Objective: This study was designed supportive care in patients with faecal incontinence. Design of study: A crossover randomized clinical trial. Study population: patients with fecal incontinence have appendicostomy. Sample size: 30 intervention studies: irrigation pumps effects on the toileting time , volume of infusion and quality of continence. Intervention time: 2 weeks primary outcome: toileting time, volume of infusion required to colon irrigation, fecal incontinence quality by CCF-FI score. Secondary outcomes of the study: The time required for the injected fluid to the colon, Duration of excretion of the injected fluid, Abdominal pain and nausea during fluid injection.

General information

Acronym
CRIS(colon rapid irrigation set)
IRCT registration information
IRCT registration number: IRCT2013020810519N2
Registration date: 2013-03-09, 1391/12/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Rezvan Mirzaee
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9056
Email address
r-mirzaee@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Colorectal Research Center, Rasoul Akram Hospital,Tehran, Iran.
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of pump to reduce the time required for the appandicostomy colonic irrigation in patients with fecal incontinence compared to the traditional method.
Public title
Appendicostomy colonic irrigation by pump
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patient consent to inclusion. there is appendicostomy or any type of ostomy for colon irrigation(cecostomy, neoappendicostomy). at least 2 months using appendicostomy colon irrigation. no case of known case of psychological disease. Exclusion criteria: Patient dissatisfaction to entering or Continue participation in the study. Complications during the study.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences ethic committee
Street address
Number 23, Dameshgh St, Palesteen St, Keshavarz Blv
City
Tehran
Postal code
Approval date
2012-11-13, 1391/08/23
Ethics committee reference number
1958/130/د/91

Health conditions studied

1

Description of health condition studied
Fecal incontinence
ICD-10 code
R15
ICD-10 code description
Faecal incontinence

Primary outcomes

1

Description
colon irrigation time
Timepoint
Exactly after intervention
Method of measurement
minute

2

Description
volume of infusion for colon irrigation
Timepoint
Exactly after intervention
Method of measurement
ml

3

Description
CCF-FI score
Timepoint
one week after intervention
Method of measurement
according to CCF-FIS guideline

Secondary outcomes

1

Description
Duration of excretion after the injected fluid
Timepoint
exactly after intervention
Method of measurement
minute

2

Description
abdominal pain
Timepoint
during fluid injection(intervention)
Method of measurement
positive-negative

3

Description
nausea
Timepoint
during intervention
Method of measurement
positive-nagative

4

Description
fluid infusion time
Timepoint
exactly after intervention
Method of measurement
minute

Intervention groups

1

Description
Patients were divided into 2 groups. In the first group, each patient is asked to perform traditional colon irrigation. In this method, 1 liter fluid infused trans appendicostomy by gravity into the colon, and patients wait up to complete fecal evacuation. Patients record time duration of irrigation in the registration form. Fecal incontinence of patients scored by Cleveland Clinic Florida Score (CCF-FIS) after a week. Then, the patient is asked to use the pump for colonic irrigation. In This method, 1 liter water infused into the colon by pump. Patients after each colon irrigation record time duration of irrigation by pump to the registration form. After a week, patients score their incontinent by CCF_FIS.
Category
Lifestyle

2

Description
Patients were divided into 2 groups. In the second group, each patient is asked to perform colon irrigation by pump. In This method, 1 liter water infused into the colon by pump. Patients after each colon irrigation record time duration of irrigation by pump to the registration form. Fecal incontinence of patients scored by Cleveland Clinic Florida Score (CCF-FIS) after a week. Then, the patient is asked to perform traditional colon irrigation. In this method, 1 liter fluid infused trans appendicostomy by gravity into the colon. Patients record time duration of irrigation in the registration form. After a week, patients score their incontinent by CCF_FIS.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Departman of colorectal surgery, Rasoal Akram Hospital
Full name of responsible person
Rezvan Mizaee
Street address
Department of colorectal surgery, Rasoal Akram Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Colorectal Research Center
Full name of responsible person
Dr. Shahram Agah
Street address
Satarkhan, Niayesh, Rasoul Akram Hospital, Colorectal Research Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Colorectal Research Center
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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Mousavi
Position
Resident in General Surgery
Other areas of specialty/work
Street address
Department of general surgery, Rasoal Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6435 2215
Fax
Email
shm135978@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rezvan Mirzaee
Position
Fellowship of Colorectal Surgery
Other areas of specialty/work
Street address
Dematment of colorectal surgery, Rasoal Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6435 2215
Fax
Email
r-mirzaee@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of general surgery, Rasol Akram Hospital
Full name of responsible person
Seyed Hamzah Mousavi
Position
Other areas of specialty/work
Street address
Sattarkhan street, Niayesh Ave, Rasoul Akram Hospital
City
Tehran
Postal code
Phone
+98 44501776
Fax
Email
shm135978@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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