The object of this one center study is to determine the effect of injectable bulking agent on fecal incontinence after surgical intervention for rectal prolaps. 50 patients suffering from fecal incontinence after surgery for rectal prolapse will be enrolled to study and based on lottery will be divided into two equal groups of case and control. Important inclusion criteria is low anal tonosity ; exclusion criteria is sphincter gap >180 degree & concurrent perianal disease. Endoanal ultrasound and anal manometery (pressure at rest and squeeze) will be performed. According to Wexner table (Cleveland Clinic Florida Incontinence Score) fecal incontinence will be record (from 0 to 20). Case group receives injectable bulking agent (5cc) sub mucosally. Active ingredient is polyacrylatepolyalcohol coplymer. Anal Manometry and endosonography will be carried out at the end of the first & the sixth month after the injection as well as score of incontinence will be measured. In the control group , endosonography and anal manometry and scoring of fecal incontinence will be performed at the same time and the results will record
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092124104N2
Registration date:2015-11-05, 1394/08/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-05, 1394/08/14
Registrant information
Name
Rezvan Mirzaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66509056
Email address
mirzaei.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy of injectable bulking agent in low anal sphincter tonosity after surgical intervention for rectal prolapse
Public title
Effect of bulking agent on fecal incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: history of surgical intervention for rectal prolapse; fecal incontinence; no response to medical treatment; low tone anal sphincter
exclusion criteria: anorectal malignancy; concurrent perianal disease (abscess, fistula, sepsis); anal sphincter defect >90 degree; sphinctroplasty; IBD; radiation; psychological & cognitive problem
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Iran University of Medical Sciences
Street address
Hemmat high way
City
Tehran
Postal code
Approval date
2015-09-07, 1394/06/16
Ethics committee reference number
IR.IUMS.REC.1394.25892
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
fecal incontinence
Timepoint
before , 1month ,6 months after injection
Method of measurement
wexner score
Secondary outcomes
1
Description
correction of anal sphincter
Timepoint
before intervention , 1 &6 mounth after
Method of measurement
observation of ultrasonic scan
2
Description
pressure of anal sphincter
Timepoint
before intervention , 1 &6 mounth after
Method of measurement
anal manometery
Intervention groups
1
Description
case group: Exantia injected single dose, submucosally 5cc in anal canal.
Category
Treatment - Drugs
2
Description
control group: no treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Rasool General Hospital
Full name of responsible person
Mirzaei Rezvan
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St.,
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Javadmusavi Seyyedali
Street address
Shahid Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran Uviversity of Medical Sciences
Full name of responsible person
Mirzaei Rezvan
Position
associated profossore
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6650 9056
Fax
Email
rezvan_mirzaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Universty of Medical Sciences
Full name of responsible person
Mirzaei Rezvan
Position
associated professor
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
City
tehran
Postal code
Phone
+98 21 6650 9056
Fax
Email
rezvan_mirzaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mirzaei Rezvan
Position
Associated professor
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6650 9056
Fax
Email
rezvan_mirzaei\@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)