The purpose of this study was to compare the effect of two insufflation pressures on liver enzymes in patients who underwent laparoscopic cholecystectomy. Patients with acute chlocystitis scheduled for laparoscopic cholecystectomy were enrolled in the study. Exclusion criteria include need for changing from laparoscopic to open approach during surgery, need for increasing abdominal pressure in low pressure pneumoperitoneum group and gallbladder rupture during surgery. 130 patients were included in the study which were randomly assigned to two groups. In group 1 and group 2, 8 mmHg pressure pneumoperitoneum and 14 mmHg pressure pneumoperitoneum were used, respectively. The primary outcome measure was liver enzymes. The level of liver enzymes was measured preoperatively and 24 and 48 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205226925N2
Registration date:2015-03-09, 1393/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-09, 1393/12/18
Registrant information
Name
Shirzad Nasiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
nasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2013-01-01, 1391/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Postoperative Hepatic Function Between Low Pressure And Standard Pressure Penumoperitnoeum In Laparoscopic Cholecystectomy
Public title
Intra-abdominal Pressure During Laparoscopic Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Indication for laparoscopic cholecystectomy in patients with acute cholecystitis
Exclusion criteria: Need for changing from laparoscopic to open approach during surgery; Need for increasing abdominal pressure in 8 mmhg pneumoperitoneum group to 14 mmhg; Gallbladder rupture during surgery
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
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 Etics Committee
Street address
6 th Floor, Central Building of Tehran University of Medical Sciences, Gods St., Keshavarz Ave.