Comparing surgery speed and complications of two methods of urology surgery: Laparoscopic trocar insertion (Hasson and Visiport)
Design
The study group was patients undergoing urology, randomized clinical trial with parallel groups and 100 subjects.
Settings and conduct
In this study, patients were randomly divided to two group. One group were treated with Visiport laparoscopic method and other group Hasson surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who were underwent urological surgery
Exclusion criteria: Coagulopathy, abdominal infection , history of abdominal surgery, ascites and age under 18 years
Intervention groups
Urological Surgery
Main outcome variables
Speed and complication of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N2
Registration date:2018-06-22, 1397/04/01
Registration timing:retrospective
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
2016-04-08, 1395/01/20
Actual recruitment end date
2018-01-10, 1396/10/20
Trial completion date
empty
Scientific title
Comparing surgery speed and complications of two methods of urology surgery: Laparoscopic trocar insertion (Hasson and Visiport)
Public title
Comparison of two methods of laparoscopic trocar insertion (Hasson and Visiport) in urologic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients were underwent urological surgery
Exclusion criteria:
Having coagulopathy, abdominal infection , history of abdominal surgery, ascites and age under 18 years old
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We divided each referral to two groups using randomized table. Consider number 1-50 for intervention A and 51-100 for for intervention B. Then lets move on one of the numbers and move one of the present direction and assign the numbers to one of the groups.Thus patients were randomly divided.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 100 patients were randomly to two groups. One group were underwent Hasson surgery and another group Visiport surgery
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
اصفهان
Province
Isfehan
Postal code
8174673461
Approval date
2016-12-30, 1395/10/10
Ethics committee reference number
396088
Health conditions studied
1
Description of health condition studied
Urological diseases
ICD-10 code
N30-N39
ICD-10 code description
Other diseases of urinary system
Primary outcomes
1
Description
speed of laparoscopy
Timepoint
During surgery
Method of measurement
The mean time
Secondary outcomes
1
Description
Infection
Timepoint
One week after surgery
Method of measurement
Via blood
Intervention groups
1
Description
Intervention group: Hasson surgery
Category
Treatment - Surgery
2
Description
Intervention group: Visiport Surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Matin Shirani
Street address
Alzahra hospital, Soffeh Blvd, Keshvari Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
matinshirani1987@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Depurty of Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Atar
Street address
Isfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
MatinShirani1987@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Depurty of Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Matin Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan university of Medical Sciences, Hezar Jareeb street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
Matinshirani1987@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Matin Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
983136202020
Phone
+98 31 3620 2020
Email
Matinshirani1987@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Matin Shirani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
matinshirani1987@gmail.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
No - There is not 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