Objectives: Determine the effects of ERCP complications in patients receiving Diclofenac suppository with patients receiving acetaminophen suppositories in patients with gallstones
Design: Randomized, Not-blind.
The main inclusion criteria to study: the need for ERCP (Endoscopic Retrograde Cholangiopancreatography) due to gallstones.
The main exclusion criteria from study: presence of coagulation disorders have already been diagnosed; Taking medications that may interfere with coagulation tests.
Intervention group: Diclofenac Suppository, Before ERCP
Control group: Acetaminophen Suppositories, Before ERCP
Primary outcome measure: Bleeding rate, During ERCP and during 24 hours after ERCP, By monitoring vital signs and clinical examination
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020616504N1
Registration date:2014-03-02, 1392/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-02, 1392/12/11
Registrant information
Name
Hadi Bagheri Hosseini
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 915 840 3741
Email address
hadibagherihh1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-01-11, 1392/10/21
Expected recruitment end date
2014-10-13, 1393/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ERCP complications with Diclofenac suppository and Acetaminophen suppository patients with CBD stone
Public title
Determine the effects of ERCP complications in patients receiving diclofenac suppository with patients receiving acetaminophen suppositories in patients with gallstones
Purpose
Diagnostic
Inclusion/Exclusion criteria
The main inclusion criteria to study: the need for ERCP (Endoscopic Retrograde Cholangiopancreatography) due to gallstones.
The main exclusion criteria from study: presence of coagulation disorders have already been diagnosed; Taking medications that may interfere with coagulation tests.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
911196
Health conditions studied
1
Description of health condition studied
Nonsteroidal anti-inflammatory drugs
ICD-10 code
Y45.3
ICD-10 code description
Other nonsteroidal anti-inflammatory drugs
Primary outcomes
1
Description
Bleeding rate
Timepoint
During ERCP and during 24 hours after ERCP
Method of measurement
Monitoring vital signs and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diclofenac Suppository, Once before ERCP
Category
Treatment - Drugs
2
Description
Control group: Acetaminophen Suppositories, Once before ERCP
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hadi Bagheri Hosseini
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ramezani
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad 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
Imam Reza Hospital
Full name of responsible person
Hadi Bagheri Hosseini
Position
Student of Subspecialist
Other areas of specialty/work
Street address
No 26, Palestin Street 15, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1840 3741
Fax
Email
Hadibagheri-h@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Abbas Esmaeelzadeh
Position
Subspecialist of Gastroenterology
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1859 8818
Fax
Email
esmaeelzadeha@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Hadi Bagheri Hosseini
Position
Student of Subspecialist
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1840 3741
Fax
Email
Hadibagheri-h@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)