1. Comparison of the effectiveness of deltiazem and placebo gel on pain score after anorectal surgery
Design
The clinical trial consists of two groups of intervention and control. Candidates for anorectal surgery are randomly selected by blocking method. The study is a double-blind study on 144 patients and the data were collected with SPSS22 software.
Settings and conduct
This study is a double-blind randomized clinical trial. 144 patients who are candidates for anorectal surgery in Shahid Beheshti Hospital in Qom will be randomly divided into two groups. The groups will be selected in such a way that individuals will be assigned to the groups based on block randomization. The intervention group will receive diltiazem gel immediately after the operation and then every 8 to 24 hours. The actions are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria All anorectal surgery candidates who have given informed consent and
Criteria for excluding clinical trial patient dissatisfaction - pregnant women - sensitivity to diltiazem gel.
Intervention groups
The intervention group is patients who are candidates for anorectal surgery who receive postoperative diltiazem gel and these patients are randomly selected and the effect of diltiazem gel on postoperative pain and postoperative complications on them is investigated. The control group of patients are candidates for anorectal surgery who receive placebo and are compared with the intervention group in terms of postoperative pain score.
Main outcome variables
pain score after anorectal surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120118008769N5
Registration date:2021-11-28, 1400/09/07
Registration timing:retrospective
Last update:2021-11-28, 1400/09/07
Update count:0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
Seyed Jalal Eshagh Hosseini
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25171181
Email address
j.hosseini@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of diltiazem gel in reducing complications and pain of anorectal surgery in patients candidates for anorectal surgery
Public title
Evaluating the Efficacy of Diltiazem Gel in Reducing the Complications and Pain in Anorectal Operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for anorectal surgery
Informed consent
Exclusion criteria:
Pregnant women
Sensitivity to diltiazem gel
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization The study was performed using block randomization. To do this, permutation blocks have been used. Data were analyzed with SPSS 22 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical trial is two-way blind. Participants in this trial and the main researcher
They do not know the type of medicine the patient is taking (diltiazem gel, placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.MUQ.REC.1400.008
Health conditions studied
1
Description of health condition studied
Anorectal surgery
ICD-10 code
K60.5
ICD-10 code description
Anorectal fistula
Primary outcomes
1
Description
Postoperative pain score
Timepoint
Immediately after surgery then every 8 hours to 24 hours
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group receiving 2% diltiazem gel from Sobhan Pharmaceutical Company, one applicator immediately after surgery and every eight hours for the first 24 hours after anorectal surgery
Category
Treatment - Drugs
2
Description
Control group: Placebo receiving group (placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Farabi Limited Surgery Center
Full name of responsible person
Seyed Jalal Eshaqh Hoseini
Street address
Shahid Beheshti St., Ammar Yaser St.
City
Qom
Province
Ghoum
Postal code
3719965654
Phone
+98 25 3612 2000
Fax
+98 25 3612 2824
Email
Shahidbeheshti@muq.ac.ir
Web page address
https://bmc.muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Street address
Qom University of Medical Sciences ,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1300
Fax
+98 25 3107 1300
Email
deanofuniversity@muq.ac.ir
Web page address
http://www.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom University of Medical Science
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qom University of Medical Sciences,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2827
Fax
+98 25 3612 2827
Email
J.hosseni@muq.ac.ir
Web page address
http://dreshagh.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Seyed Jalal eshaqh Hoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Qom University of Medical Sciences, Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
J.hosseini@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zohre Esfandyari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital,Shahid Beheshti St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2827
Email
Sfand_h@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available