This study was a randomized, double blind, prospective, placebo-controlled trial. Patients with symptomatic third and fourth degree hemorrhoids undergoing Milligan-Morgan surgery were recruited. Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoid surgery, or those who had experienced side effects of calcium channel blockers and those who were pregnant were excluded. Patients were randomized to either Diltiazem or placebo treatment group. Patients were discharged after surgery with a care package that included 2% Diltiazem or placebo ointment. Patients were asked to use the ointments (1gr, 3 times daily for 1 week). Postoperative pain was evaluated using a self-administered visual analogue scale (VAS) as primary outcome measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710281558N1
Registration date:2009-05-08, 1388/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-08, 1388/02/18
Registrant information
Name
Farshad Jalili
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 1562
Email address
jalilish@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sina Hospital, Tehran University of Medical Sciences
Expected recruitment start date
2007-09-27, 1386/07/05
Expected recruitment end date
2008-01-02, 1386/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%
Public title
Pain Reduction after Hemorrhoidectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: grade 3 and 4 hemorrhoid
Exclusion Criteria: history of heart disease, blood pressure, orthostatic hypertension, hemorrhoid surgery, side effects of calcium channel blocker drugs, pregnancy.
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran Univercity of Medical Sciences
Street address
Enghelab Street
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
724
Health conditions studied
1
Description of health condition studied
haemorrhoid
ICD-10 code
I84
ICD-10 code description
Haemorrhoids
Primary outcomes
1
Description
Pain after hemorrhoidectomy
Timepoint
Every day in a week period after surgery
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
Bleeding after hemorrhoidectomy
Timepoint
Baseline and 1 week after surgery
Method of measurement
Bleeding in cc by medical history
2
Description
Analgestic usage after hemorrhoidectomy
Timepoint
Baseline and 1 week after surgery
Method of measurement
Number of pills used by the paitents
Intervention groups
1
Description
Diltiazem Ointment 2%, 1 gram, 3 times daily, for 1 week, on scar
Category
Treatment - Drugs
2
Description
Placebo,3 times daily,for 1 week,on scar
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Farshad Jalili Shahandashti
Street address
Imam khomeini Street, Imam khomeini Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Farshad Jalili Shahandashti
Full name of responsible person
Dr Farshad Jalili Shahandashti
Street address
Imam khomeini Avenue,Imam khomeini Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr Farshad Jalili Shahandashti
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
Sina Hospital
Full name of responsible person
Dr Farshad Jalili Shahandashti
Position
Resident of Surgery
Other areas of specialty/work
Street address
Imam khomeini Street,Imam khomeini Avenue
City
Tehran
Postal code
Phone
+98 912 199 2369
Fax
Email
jalilish@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr Hadi Ahmadi Amoli
Position
General Surgeon
Other areas of specialty/work
Street address
Imam khomeini Street, Imam khomeini Avenue
City
Tehran
Postal code
Phone
Fax
Email
ahmadiam@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Farshad Jalili shahandahti
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)