The aim of this study is to compare the cholecystectomy laparoscopic 3 and 4 portes of safety, this study is randomized clinical trial.
Participants including major eligibility criteria, one hundred patients choice among sicks candidate for cholecystectomy treatment in sina hospital.
Patient divide two fifty groups with similar risk factor sub intervention group with three portes and control group with four ports cholecystectomY laparoscopic.
All patients treatment via one surgen and one kind drug anesthesia and opioid with relievable.
Main out come measures: Cholecystectomy laparoscopic 3 and 4 portes of safety based on: Bleeding, Kind of sore.
Purposes approviated evaluation are checking time of hospital admission and measure of used opioid and sedation and transformation to open cholesistectomy and checking of patientes satisfaction. usage purpoeses include painless after surgery and decrease of costes and better resulte of cosmetic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110219788N1
Registration date:2015-06-13, 1394/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Reza Mirzaie
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41333470549
Email address
mirzaira@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences/ Vice chancellor for reseach
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three port with standard four port laparoscopic cholecystectomy
Public title
Comparison of three port with standard four port laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with symptomatic cholelithiasis and acute and chronic cholesistitis;
Exclusion criteria: pregnancy; morbid obesity; common bile duct stones; Obstructive jaundice; cirrhosis; uncorrectable coagolopathy; previous surgery in the upper abdomen; heart failure; ascites .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Avenue, azadi street, Tabriz
City
Tabriz
Postal code
Approval date
2014-12-18, 1393/09/27
Ethics committee reference number
93149
Health conditions studied
1
Description of health condition studied
Colelithiasis
ICD-10 code
k80.0, K8
ICD-10 code description
Calculus of gallbladder with acute cholecystitis, Calculus of gallbladder with other cholecystitis, Calculus of gallbladder without cholecystitis
Primary outcomes
1
Description
Content of beelding
Timepoint
Time of operation, After surgery
Method of measurement
Based on: Observation beelding drain discharge
2
Description
Use narcotic drug
Timepoint
Surgery time and after surgery
Method of measurement
With pac system
3
Description
Hospitalization time
Timepoint
from entrance unit until discharge
Method of measurement
numeration of hospitalization days
Secondary outcomes
1
Description
Patient satisfaction of pain decline
Timepoint
After surgery
Method of measurement
From pain scale
2
Description
Damage of bile ducts
Timepoint
In operation time and after
Method of measurement
With observation and written complication
Intervention groups
1
Description
Intervention:3 ports laparoscopic in patient with gallstone and colisistit
Category
Treatment - Surgery
2
Description
Control:cholecystectomy laparoscopic 4 ports in patient
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina Hospital
Full name of responsible person
Dr Reza Mirzaie
Street address
Sina Hospital, Between Maralan and Hafez, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences/ Vice chancellor for reseach
Full name of responsible person
Dr Alireza Barband
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences/ Vice chancellor for reseach
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
Tabriz University Of Medical Science
Full name of responsible person
Dr Reza Mirzaie
Position
Surgent Resident
Other areas of specialty/work
Street address
Sina Hospital, Between Maralan and Hafez Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3329 8511
Fax
Email
remix1360@gmail.com mirzaira@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Alireza Barband
Position
Professor Assistant
Other areas of specialty/work
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 5924
Fax
Email
alibarband@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Dr Reza Mirzaie
Position
Surgent Resident
Other areas of specialty/work
Street address
Sina Hospital, Between Maralan and Hafez Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3541 2101
Fax
Email
remix1360@gmail.com mirzaira@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)