Protocol summary

Summary
The main Objective is comparison of indicators of stress response following laparoscopic cholecystectomy with low intra-abdominal pressure compared to the standard intra-abdominal pressure by a a randomized, double-blind, single-center Study in Shariati hospital, Tehran, Iran. We study patients with indication of Laparoscopic Cholecystectomy due to biliary colic who aged 18 years or older, with the American Society of Anesthesiologists (ASA) Physical Status I or II . We Exclude cases with acute cholecystitis, concurrent inflammatoary condition like acute pancreatitis, uncured malignancy, major intraoperative or postoperative complications and severe systemic disease. Interventions: 50 patients will be divided randomly into two equal groups: In one group laparoscopic cholecystectomy is done with low intra-abdominal Co2 pressure (8 mmHg) and in the other group with standard intra-abdominal Co2 pressure (14 mmHg). After induction of anesthesia (based on a protocol), patients are allocated to groups according to the random list. Blood Cortisol, blood glucose, CRP and adrenalin will be checked preoperatively, 6 and 24 hours postoperatively. Furthermore, End tidal CO2 and vital signs will be measured at the beginning of the surgery (before entering the gas to the abdomen), each 15 minutes during the surgery and at the end of the operation. the aforementioned items will be compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110072982N5
Registration date: 2012-04-11, 1391/01/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-11, 1391/01/23
Registrant information
Name
Zhamak Khorgami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
khorgami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of stress response to laparoscopic cholecystectomy with low or standard intra-abdominal pressure in Shariati Hospital in 1390-1391
Public title
Stress response to laparoscopy with low pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) patients aged 18 years or older 2) with diagnosis of biliary colic and 3) ASA class I or II , who were 4) candidate for Laparoscopic cholecystectomy admitted in Shariati hospital, Tehran Exclusion criteria: 1) Cases of acute cholecystitis, 2) concurrent inflammatoary condition like acute pancreatitis, 3) uncured malignancy, 4) major intraoperative or postoperative complications and 5) severe systemic disease (ASA class three or greater)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Tehran university of medical sciences
Street address
Central building of Tehran university of medical sciences, Qhods avenue
City
Tehran
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
130/1584/د/90

Health conditions studied

1

Description of health condition studied
Biliary Colic
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis

2

Description of health condition studied
stress response
ICD-10 code
R79.9
ICD-10 code description
Abnormal finding of blood chemistry, unspecified

Primary outcomes

1

Description
blood cortisol
Timepoint
preoperatively, 6 and 24 hours postoperatively
Method of measurement
laboratory based on mg/dl

2

Description
CRP
Timepoint
preoperatively, 6 and 24 hours postoperatively
Method of measurement
laboratory based on mg/l

3

Description
blood glucose
Timepoint
preoperatively, 6 and 24 hours postoperatively
Method of measurement
laboratory based on mg/dl

4

Description
blood adrenalin
Timepoint
preoperatively, 6 and 24 hours postoperatively
Method of measurement
laboratory based on pg/ml

Secondary outcomes

1

Description
urine volume
Timepoint
during surgery
Method of measurement
urine bag based on cc

2

Description
heart rate
Timepoint
at the beginning of surgery, every 15 minutes and at the end of the surgery
Method of measurement
monitoring equipment based on pulse rate per minute

3

Description
length of surgery
Timepoint
after surgery
Method of measurement
watch based on minutes

4

Description
end tidal CO2
Timepoint
at the beginning of surgery, every 15 minutes and at the end of the surgery
Method of measurement
Capnography based on mmhg

5

Description
mean arterial pressure
Timepoint
at the beginning of surgery, every 15 minutes and at the end of the surgery
Method of measurement
monitoring equipment based on mmhg

Intervention groups

1

Description
Group 1 (standard intraabdominal pressure): Laparoscopic cholecystectomy is performed using CO2 with standard intra-abdominal pressure of 14 mmHg.
Category
Treatment - Surgery

2

Description
Group 2 (Low intraabdominal pressure): Laparoscopic cholecystectomy is performed using CO2 with low intra-abdominal pressure of 8 mmHg.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Street address
Shariati Hospital, North Kargar Avenue,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhonzade
Street address
Research deputy, Medicine faculty, Poursina avenue, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences - Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences - Shariati hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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