The purpose of this study is showing that intra operative ultrasound during the laparoscopy cholesystectomy prepare a better visualization for surgeon and since obesity and intestinal gas, don’t make restrictions on the diagnosis therefor, it can show a better anatomic view to surgeon. We study patients who are candidate for cholecystectomy. The exclusion criterion includes the patients whose laparoscopy are converts to laparotomy. The sample size for this study is 150 patients. The participants are divided into two groups randomly. Intra operative ultrasound is done just in one group and the intraoperative complication such as bile duct injury will be assessed in both groups. Intra operative Sonography can reduce the risk of intra operative billiary tract injury.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209278588N11
Registration date:2012-11-06, 1391/08/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univarsity of Medical Sciences.
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of intra operative ultrasound during the laparoscopy cholesystectomyin reduce the bile ducts injury.
Public title
use of Intraoperative ultrasound in laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients with gallstones or gallbladder inflammation
Exclusion criteria: the patients whose laparoscopy are converts to laparotomy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
61289
Health conditions studied
1
Description of health condition studied
cholecystitis
ICD-10 code
K81
ICD-10 code description
Acute cholecystitis
2
Description of health condition studied
Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Bile duct injury
Timepoint
intraoperative, two days after operation
Method of measurement
clinical signs and surgeon's diagnosis
Secondary outcomes
1
Description
Finding Bile duct stone
Timepoint
intraoperative
Method of measurement
inspection in Sonography
Intervention groups
1
Description
In the intervention group, for the patients, during laparoscopic surgery ultrasound is done.
Category
Prevention
2
Description
In the intervention group, for the patients during laparoscopic ultrasound is not done.