This is a randomized clinical trial study. Sixty hospitalized patients for Anorectal surgery (Hemorrhoid, Fisher and Fistula) will be recruited by convenient sampling and then randomly allocated receive 500cc Saline or 6 Bizacodil tablets (from Sobhan company) beginning from a day before operation in order to bowel preparation. Then, participants will be operated with similar anesthesia method. Surgeon’s and patient’s satisfaction and complications of surgery will be evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905094477N1
Registration date:2010-09-16, 1389/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-16, 1389/06/25
Registrant information
Name
Ahmad Amouzeshi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1443 0142
Email address
amouzeshiahmad@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2010-05-25, 1389/03/04
Expected recruitment end date
2011-11-25, 1390/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of saline enema and bisacodyle in rectal preparation before anorectal surgery
Public title
The comparison of two different methods in rectal preparation before anorectal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 20-60, hospitalized patients for Anorectal surgery, willingness to participate
Exclusion criteria: pregnancy, breast feeding, presence of severe cardiac or renal diseases
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari street
City
Birjand
Postal code
Approval date
2010-06-01, 1389/03/11
Ethics committee reference number
23904
Health conditions studied
1
Description of health condition studied
Chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
2
Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
3
Description of health condition studied
Hemorrhoid
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Surgeon's satisfaction
Timepoint
After surgery
Method of measurement
Form that provided by researcher
2
Description
Patient's satisfaction
Timepoint
After surgery
Method of measurement
Form that provided by researcher
Secondary outcomes
1
Description
Operation complications
Timepoint
10 days after surgery
Method of measurement
Check list
Intervention groups
1
Description
500cc Salin the night before surgery
Category
Other
2
Description
6 Bizacodil tablets, every 4 hours, since the noon before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Dehghani Firoozabadi
Street address
Birjand University of Medical Sciences, Ghafari street
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Ahmad Amouzeshi
Position
Public surgery/Chancellor for Students Affairs and Culture
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari street
City
Birjand
Postal code
Phone
+98 56 1443 0142
Fax
Email
amozeshia841@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Ahmad Amouzeshi
Position
Public surgery/Chancellor for Students Affairs and Culture
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari street
City
Birjand
Postal code
Phone
+98 56 1443 0142
Fax
Email
amozeshia841@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)