Protocol summary

Summary
The women who suffering of fecal incontinence after normal vaginal delivery (NVD) that need surgical intervension depend on anal manometry and endoanal sonogeraphy. The patients have fecal incontinance after first NVD are going to refer to colorectal clinic of shahid faghihi hospital. exclusion criteria including: without post history of gas, stool or urinary incontinance, past medical history of diabetus melitus, musculo-skeletal disorders, previous pelvic or perineal surgery, COPD, ascites, intalented to learn biofeedback therapy. inclusion criteria: women with fecal incontinence after first NVD between 20 – 40 years old lady, wexner>10, decrease manometry below 30% normal and disruption of anterior part of external sphincter in sonogeraphy evaluation more than 90 degree. The patients will separate in 3 groups including 10 persons by randomization; then in group A the patients underwent sphinctroplasty- levatorplasty surgery. In group B, after sphinctroplasty- levatorplasty surgery, biofeedback therapy are going to do for 6 month. In group C at first, 3 month pre operation and 6 month post operation biofeedback therapy will perform; then after one & three months the patients will be evaluated again & wexner form will be completed by colorectal surgeon. Six months after operation, wexner, manometry & endo anal sonogeraphy will be done again and the patients are going to be evaluated. The manometry & endoanal sonogeraphy will performed by colorectal surgeon.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206039936N1
Registration date: 2012-08-22, 1391/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-22, 1391/06/01
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-31, 1391/05/10
Expected recruitment end date
2013-01-29, 1391/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effecacy of preoperative and postoperative biofeedback therapy before sphictroplasty- levatorplasty for fexal incontinance managment due to obstetric trauma
Public title
Effect of biofeedback therapy with surgery in managment of fecal incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with fecal incontinence after first NVD between 20 – 40 years old lady; wexner>10; decrease manometry below 30% normal and disruption of anterior part of external sphincter in sonogeraphy evaluation more than 90 degree. Exclusion criteria: history of gas, stool or urinary incontinance; past medical history of diabetus melitus, musculo-skeletal disorders, previous pelvic or perineal surgery, COPD, ascites, intalented to learn biofeedback therapy.
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shahid Faghihi hospital
City
Shiraz
Postal code
7134844119
Approval date
2012-01-08, 1390/10/18
Ethics committee reference number
90-01-01-3247

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
Fecal incontinance
Timepoint
Before surgery, one, three, sex months post operation
Method of measurement
Wexner, anal manometry, endoanal sonography

Secondary outcomes

1

Description
Improvment in manometry and endoanal sonography
Timepoint
Pre operation and six months post operation
Method of measurement
Manometry score and external sphincter degree in endoanal sonography evaluation

Intervention groups

1

Description
Patients who undergo sphincteroplasty-levatorplasty; control group
Category
Treatment - Surgery

2

Description
Patients who would be train to do post operation biofedback theraphy to six months after surgery.
Category
Rehabilitation

3

Description
Patients who would be train to do biofidback therapy 3 months pre operation till six months post operation.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Colorectal surgery clinic, Shahid Faghihi hospital
Full name of responsible person
Dr Leila Ghahramani
Street address
Shahid Faghihi hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Office of Research and Consultative Collaboration
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Leila Ghahramani
Position
Colorectal surgery felowship - assistant professor
Other areas of specialty/work
Street address
Shahid Faghihi hospital
City
Shiraz
Postal code
7134844119
Phone
+98 71 1230 6972
Fax
+98 23 31006
Email
leila_ghahramani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr Leila Ghahramani
Position
colorectal flowship- assistant professor
Other areas of specialty/work
Street address
Shahid Faghihi hospital
City
Shiraz
Postal code
7134844119
Phone
+98 71 1230 6972
Fax
+98 23 31006
Email
leila_ghahramani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Leila Ghahramani
Position
colorectal flowship- assistant professor
Other areas of specialty/work
Street address
Shahid Faghihi hospital
City
Shiraz
Postal code
7134844119
Phone
+98 71 1230 6972
Fax
+98 23 31006
Email
leila_ghahramani@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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