evaluate effect of albendazole on the scoleces viability in hepatic hydatid cyst
Design
clinical trial study with intervention and control groups. community based, simple randomized sampling and blinded outcome assessment.
Settings and conduct
A clinical trial study was conducted to evaluate the therapeutic effect of albendazole on liver hydatid cysts in Mashhad and Imam Reza Hospital. One-way blinding involves a parasitic specialist who performs a sample of cysts.
Participants/Inclusion and exclusion criteria
Patients with hepatic hydatid cyst, whose diagnosis is confirmed by imaging, are included in the study if they are satisfied with the research, and patients who are not satisfied with the study, or who have extrahepatic abdominal hydatid cyst, have pulmonary hydatid cyst or have infectious cysts or who they are related to bile ducts are not included in the study from the beginning.
Intervention groups
Patients are divided into two groups. The first group is given a specific dose of Albendazole for a period of 2 weeks and then undergoes surgery.In the second group, no drugs are prescribed and they are directly subjected to surgery.
Main outcome variables
The use of albendazole for a 2 week period prior to surgery in patients with hepatic hydatid cyst reduces the survival rate of the scoleces in the hydatid cyst.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090124001581N3
Registration date:2018-04-24, 1397/02/04
Registration timing:registered_while_recruiting
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Mohammad Reza Motie
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5255
Email address
motiem@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2015-09-02, 1394/06/11
Expected recruitment end date
2018-09-02, 1397/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of Albendazole therapy(before surgery) on viability of protoscolex
Public title
Effects of Albendazole therapy on liver hydatid cysts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with liver hydatid cyst
patients who have not calcified cyst
patients with liver hydatid cysts that are not connected with billiary tract
patients who have not infected hydatid cyst
Exclusion criteria:
patients who do not want to participate in the study
patients who have contraindication for use of albendazole
patients with abdominal and extra hepatic hydatis cyst
patients with infected hydatid cyst
patients with hydatid cyst that are connected with biliary tracts
patients with calcified hydatis cyst
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done simple randomly. unit of randomization was individual. In order to balance the number of samples of two groups, the sampling was done using blocking method. The random allocation law was used for limited randomization methods. This method represents a large block for the entire sample size, which means that the balance in the number of people assigned to each of the groups will be at the end of the study. To do this, we first set a total sample size and then randomly assign a set of them to the intervention group and assign the remainder to the control group. In this study, an equal number of balls for the intervention group and the control group are placed in a drawer, and then the balls are randomly recorded without the replacement of the container and the resulting sequence is recorded.
Blinding (investigator's opinion)
Single blinded
Blinding description
the parasitologist specialist who evaluate the hydatis cyst scolex viability in this study has no information about the sample that if the patient had consumed drug or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
MAshhad university of medical sciences
Street address
Qoreshi building, Daneshgah avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.MUMS.FM.REC.1394.216
Health conditions studied
1
Description of health condition studied
Liver Hydatid Cysts
ICD-10 code
B67.0
ICD-10 code description
Echinococcus granulosus infection of liver
Primary outcomes
1
Description
scolex viability
Timepoint
After intervention
Method of measurement
Permeability method with eosin
Secondary outcomes
empty
Intervention groups
1
Description
There is no drug administration for control group
Category
Treatment - Drugs
2
Description
administration of Albendazole 1.5 mg/kg/day for a period of7 days for intervention group2
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Mohammad Reza Motie
Street address
Imam Reza Hospital
City
Mahshad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3834
Email
motiem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Second floor of ghorshi building, Daneshgah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
951-91735
Email
motiem@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Motie
Position
Associated proffesor of surgery
Latest degree
Specialist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2664
Fax
Email
motiem@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Surgical Oncology Research center,Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Motie
Position
Associated Proffesor of Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2664
Fax
Email
motiem@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Vahidi Rad
Position
Surgery Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2664
Fax
Email
vahidirada931@mums.ac.ir
Web page address
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
No - There is not 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