objectives:The upper abdominal operations change postoperative pulmonary function tests.Laparoscopy causes physiologic changes in the respiratory system too and diaphragmatic function is impaired extensively after laparoscopy. The factors that cause aggravation of restrictive lung disorders increase postoperative lung complications.The thesis objective is examination of Peak Expiratory Flow before , after open and laparoscopic cholecystectomy.Of course better pulmonary function tends to decrease of postoperative pulmonary complications.primary outcome measure is Peak Expiratory Flow. Methods: In this randomized clinical trial thirty ASA class I , II patients with chronic cholecystitis due to gall stone is allocated randomly into group I (open cholecystectomy with 15 patients) and group II (laparoscopic cholecystectomy with 15 patients). The Peak Expiratory Flow ( PEF) is measured one day before operation and in recovery room , 24 and 48 hours postoperatively in semisitting position. Collected data is analysed by SPSS. 17 software.Inclusion criteria: age 20-60 years old; symptomatic gall stone and ASAclass 1 & 2.
Exclusion criteria: BMI more than 30; emergency surgery; biliary duct stone; acute cholecystitis; positive history of COPD; open cholecystectomy after laparoscopic cholecystectomy and positive history of extensive upper abdominal surgery. Intervention in intervention group is laparoscopic cholecystectomy and in control group is open cholecystectomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012061710055N1
Registration date:2012-08-22, 1391/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-22, 1391/06/01
Registrant information
Name
Mohammad Mehdi Derakhshan
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1635 7114
Email address
derakhshan.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative peak expiratory flow in open versus laparoscopic cholecystectomy.
Public title
Pulmonary function after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20-60 years old; symptomatic gall stone and ASAclass 1 & 2.
Exclusion criteria: BMI more than 30; emergency surgery; biliary duct stone; acute cholecystitis; positive history of COPD; open cholecystectomy after laparoscopic cholecystectomy and positive history of extensive upper abdominal surgery.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jondishapour University of Medical Sciences
Street address
golestan runway
City
ahvaz
Postal code
Approval date
2011-04-22, 1390/02/02
Ethics committee reference number
eth-442
Health conditions studied
1
Description of health condition studied
Gall stone
ICD-10 code
K80.2
ICD-10 code description
Cholecystolithiasis
Primary outcomes
1
Description
Peak Expiratory Flow (PEF)
Timepoint
One day before intervention , in recovery room , 24 and 48 hours after intervention
Method of measurement
with peak fiow meter/litre per minute
Secondary outcomes
1
Description
BMI
Timepoint
One day before operation
Method of measurement
Measurment of weight and height /kg per square meter