The aim of this study is assessment of efficacy of Cholestyramine, 15% ointment on postsurgical pain of hemorrhoidectomy. Ninety-one (91) patients were randomly enrolled to receive either Cholestramine (n=47) or placebo (n=44). Inclusion criteria were presence of internal hemorrhoids degrees three and four. Exclusion criteria were anal fissure, previous hemorrhoidectomy, drug addiction, pregnancy, presence of cirrhosis, receiving oral nitroglycerin or Cholestyramine. Patients in intervention group received 15% Cholestyramine ointment with almond oil rubbed on the site of rectal wound, immediately and 12 hours after surgery and then 3 grams three times daily for 14 days. In control group almond oil was used as placebo with the same dose and administration route. Pain after surgery and pain after defecation were compared between two groups as outcomes of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803091627N2
Registration date:2009-06-27, 1388/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-27, 1388/04/06
Registrant information
Name
Fariborz Eshghi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 2033
Email address
feshghy@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2007-09-06, 1386/06/15
Expected recruitment end date
2008-09-05, 1387/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of 15% cholestyramin ointment on pain reduction after surgery of removal of hemorrhoid
Public title
Efficacy of 15% cholestyramin ointment on pain reduction after hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 70 years, presence of hemorrhoid grade III or IV
Exclusion criteria: Presence of anal fissure, previous hemorrhoidectomy, substance abuse, pregnancy, presence of cirrhosis, and receiving oral Nitroglycerin or Cholestyramine
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
91
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences and Health Services
Street address
Mazandaran University of Medical Sciences and Health Services, Imam Sq, Joybar 3way,
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
87-86
Health conditions studied
1
Description of health condition studied
heamorrhoid grade III, IV
ICD-10 code
I84.1
ICD-10 code description
Internal haemorrhoids with other complications
Primary outcomes
1
Description
Doses of opioid or Tramadol
Timepoint
48 hours after surgery
Method of measurement
Sum of injected doses
2
Description
Pain after surgery
Timepoint
12, 24, 48 hours and 2, and 4 weeks after surgery
Method of measurement
VAS
3
Description
Pain after defecation
Timepoint
12, 24, 48 hours and 2, and 4 weeks after surgery
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
15% Cholestyramin ointment with almond oil on the site of rectal wound, immediatly after surgery and 12 hours later then 3 gr three times daily for 14 dayes
Category
Treatment - Drugs
2
Description
Almond oil, on the site of rectal wound immediatly after surgery and 12 hours later then 3 gr three times daily for 14 dayes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini hospital
Full name of responsible person
Faribirz Eshghi (MD)
Street address
General surgery department, Imam Khomani hospital, Razi street
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Sayed Jalal Hosseini Mehr
Street address
Moallem Square,
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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
mazandaran univercity of medical sciences and Health ervices