Determining the effect of pelvic floor physiotherapy in children with fecal incontinence after surgery for anorectal malformation compared with conventional medical treatment
Design
A randomized clinical trial study with a control group and single blind. The final sample size will be 15 people in each group.
Settings and conduct
This study will be performed in the specialized clinic of Tabriz University of Medical Sciences. Thirty children with fecal incontinence after surgery for anorectal malformation aged 4 to 6 years participated in the study with the consent of their parents. This study will be conducted in a single-blind manner and with the blinding of a researcher and statistician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with fecal incontinence after surgery for anorectal malformations at preschool age (4 to 6 years).
These malformations include recto-perinatal fistula and closed anus without fistula in both sexes, which undergo corrective anorectoplasty surgery in three stages before 6 months of age (colostomy at birth and anorectoplasty and then colostomy closure).
Exclusion criteria:
Children with associated anomalies such as myelomeningocele, congenital hip dislocation, multiple anomalies; Children with learning disabilities.
Intervention groups
Intervention group: Pelvic floor physiotherapy including electrical stimulation, biofeedback, and pelvic floor exercises to strengthen the pelvic floor muscles and improve sphincter function.
control group: A routine care consists of laxatives and controlling diet and advising to be physically active
Main outcome variables
Severity of fecal incontinence and severity of constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140811018760N7
Registration date:2021-04-15, 1400/01/26
Registration timing:prospective
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor physiotherapy in children with fecal incontinence after surgery for anorectal malformation
Public title
The effect of pelvic floor physiotherapy in children with fecal incontinence after surgery for anorectal malformation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with fecal incontinence after surgery for anorectal malformation include recto-perinatal fistula and closed anus without fistula
Preschool age (4 to 6 years) undergo corrective anorectoplasty surgery in three stages before 6 months of age (colostomy at birth and anorectoplasty and then colostomy closure).
Both sexes
Exclusion criteria:
Children with associated anomalies such as myelomeningocele, congenital hip dislocation, multiple anomalies
Children with learning disabilities
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly divided into two groups of 15 participants in the intervention and control groups using a random blocking method with block sizes of 4 and 6 and allocation ratio of 1:1. The output will be A or B that each one is representative of one of the groups. To conceal the allocation, the intervention type will be written on a sheet of paper and placed in a opaque envelope with order number on them. َ Envelopes will be opened in the order as soon as a participant join the study, so the type of group will identified.
Blinding (investigator's opinion)
Single blinded
Blinding description
This will be a single-blind study, according to the process of interventions, the therapist and the patient can not be blind to the interventions,only the data assessor will be blind to the study groups. The allocation process to the groups will be concealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of Rehabilitation, Daneshgah St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.TBZMED.REC.1399.955
Health conditions studied
1
Description of health condition studied
Fecal incontinence
ICD-10 code
R15
ICD-10 code description
Fecal incontinence
Primary outcomes
1
Description
Severity of fecal incontinence
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
Rintala Questionnaire
2
Description
Severity of constipation
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
Pediatric constipation score Questionnaire
Secondary outcomes
1
Description
Pelvic floor muscles strength
Timepoint
At the beginning of the study (before the intervention) and at the end of the intervention
Method of measurement
The strength of pelvic floor muscles will be determined by rectal digital examination and oxford scale.
Intervention groups
1
Description
Intervention group: Pelvic floor physiotherapy consists of once a week progressive pelvic floor exercises, biofeedback and electrical stimulation at pelvic floor physiotherapy clinic for 12 weeks. Each session will take 40-50 minutes. Exercises will continued every day at home.
Category
Treatment - Other
2
Description
Control group: A routine care consists of laxatives and controlling diet and advising to be physically active
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pelvic floor physiotherapy clinic - Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Pelvic floor physiotherapy clinic - Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 41 3329 9799
Email
ghaderif@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Tabriz, University street, Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Daneshgah St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Daneshgah St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Daneshgah St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol, statistical analysis data and informed consent form will be available if requested by another researcher via email.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
For researchers working in scientific and academic institutions
Under which criteria data/document could be used
At the request of the journals or the reviewers of the journals
From where data/document is obtainable
By email and by providing documentation for authentication through the project manager Dr. Fariba Ghaderi ghaderimailbox@gmail.com or ghaderif@gmail.com
What processes are involved for a request to access data/document
Send request via email and authentication documents