Determination the effect of CO2 gas flow rate on postoperative complications in laparoscopic surgery
Design
This study will be conducted as a randomized, double-blind clinical trial.
Settings and conduct
This study is about the effect of flow rate of CO2 gas on postoperative complications in laparoscopic surgery in Imam Khomeini Hospital in Kermanshah. In this study, the patients and the peoples who measuring the variables would be unaware of the presence of patients in the first group and or in the second groups. Only the surgeon aware about grouping.
Participants/Inclusion and exclusion criteria
Ages between 18 and 65 years old and have laparoscopic surgery; patients with history of motion sickness, diabetes, cardiovascular failure, severe nausea and vomiting in past surgery; patients with concurrent surgery; patients under treatment with narcotic drugs or non-steroidal anti-inflammatory drugs.
Intervention groups
Intervention: In order to be able to do surgery in the abdomen, in new surgery, they injected some CO2 into the abdominal area, until with the opening of the organs from one another, access is easy for surgeon. Speed of entering the gas into the abdominal cavity at the beginning of the laparoscopic surgery is done in both low speed and high speed. Intervention group: patients who are eligible for inclusion in the study are included in the study and without knowing that it is only the first group (under the operation with blowing CO2 gas at low speed) or the second group (under the operation with blowing CO2 gas at high speed) , surgery happens to them.
Main outcome variables
The amount of pain after laparoscopic surgery; nausea; vomitting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100609004141N3
Registration date:2018-12-18, 1397/09/27
Registration timing:registered_while_recruiting
Last update:2018-12-18, 1397/09/27
Update count:0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
ezatollah sadeghi
Name of organization / entity
kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6325
Email address
dr.makhsosy@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing effect of flow rate of CO2 gas on postoperative complications in laparoscopic surgery
Public title
Assessing effect of flow rate of CO2 gas on postoperative complications in laparoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 and 65 years old
Have laparoscopic surgery
Exclusion criteria:
Patients with history of motion sickness, diabetes, cardiovascular failure
Patients with concurrent surgery
Patients under treatment with narcotic drugs or non-steroidal anti-inflammatory drugs
History of severe nausea and vomiting in past surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
The assignment of patients to each group will be applied based on randomization block to control the effect of age and sex. And so on the proportion of sex (women and men) and age (under 40, 40 years old and more) will be approximately the same in the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the peoples how measuring the variables would be unaware of the presence of patients in the first group and or in the second groups. Only the surgeon aware about grouping, after of ending the evoluation of necessary variables, groups of each person will be spesified in cheklist, based on coding system.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.KUMS.REC.1397.200
Health conditions studied
1
Description of health condition studied
Flow rate of CO2 gas , Postoperative complications in cholecystectomy laparoscopic surgery
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
2
Description of health condition studied
Flow rate of CO2 gas , Postoperative complications in herniorafi laparoscopic surgery
ICD-10 code
K43
ICD-10 code description
Ventral hernia
Primary outcomes
1
Description
The amount of pain after laparoscopic surgery
Timepoint
1- Immediately after the start of surgery 2- Three months after surgery
Method of measurement
Visual Measurement Scale; VAS
2
Description
The amount of nausea after laparoscopic surgery
Timepoint
1- Immediately after the start of surgery 2- Three months after surgery
Method of measurement
Visual Measurement Scale; VAS
3
Description
The amount of vomit after laparoscopic surgery
Timepoint
1- Immediately after the start of surgery 2- Three months after surgery
Method of measurement
Visual Measurement Scale; VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: In order to be able to do surgery in the abdomen, in new surgery, they injected some CO2 into the abdominal area, until with the opening of the organs from one another, access is easy for surgeon. Before inserting a laparoscope into the abdomen through the primary port, the peritoneal cavity is fills up with CO2 by an inoculatory device (a device that sends the calculated amount of gas from the gas through a controlled pressure between 18-12 mm Hg into the abdomen). In many cases, determining the flow rate of CO2 gas that can have different effect on organs, done by the surgeon. Speed of entering the gas into the abdominal cavity at the beginning of the laparoscopic surgery is done in both low speed and high speed in according to (L / min CO2). Intervention group: Patients who are eligible for inclusion in the study are included in the study and without knowing that it is only the first group (under the operation with blowing CO2 gas at low speed) or the second group (under the operation with blowing CO2 gas at high speed) , surgery happens to them. In this section, the intervention group 1; people are in the first group.
Category
Treatment - Surgery
2
Description
Intervention: In order to be able to do surgery in the abdomen, in new surgery, they injected some CO2 into the abdominal area, until with the opening of the organs from one another, access is easy for surgeon. Before inserting a laparoscope into the abdomen through the primary port, the peritoneal cavity is fills up with CO2 by an inoculatory device (a device that sends the calculated amount of gas from the gas through a controlled pressure between 18-12 mm Hg into the abdomen). In many cases, determining the flow rate of CO2 gas that can have different effect on organs, done by the surgeon. Speed of entering the gas into the abdominal cavity at the beginning of the laparoscopic surgery is done in both low speed and high speed in according to (L / min CO2). Intervention group: Patients who are eligible for inclusion in the study are included in the study and without knowing that it is only the first group (under the operation with blowing CO2 gas at low speed) or the second group (under the operation with blowing CO2 gas at high speed) , surgery happens to them. In this section, the intervention group 2; people are in the second group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital in Kermanshah
Full name of responsible person
Dr Behnam Reza Makhsosy
Street address
Imam Khomeini Hospital in Kermanshah, Naghliye avenue, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
ihosp@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behnam Reza Makhsosy
Position
Managing Director of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
dr.makhsosy@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kermanshah University of Medical Sciences
Position
Managing Director of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
dr.makhsosy@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharmin Rahmani
Position
Researcher of Research Unit, Imam Khomeini Hospital, Kermanshah
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Imam Khomeini hospital in Kermanshah, Naghliye avenue, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
sh.rahmani90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the samples being unidentifiable, data is publishable .
When the data will become available and for how long
The access period;
Starts 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who try to help science can use data.
From where data/document is obtainable
Expert of Research Unit of Imam Khomeini Hospital in Kermanshah , Sharman Rahmani , sh.rahmani90@yahoo.com
What processes are involved for a request to access data/document
1- Send a request to sh.rahmani90@yahoo.com
2. The purpose of the data request, stated clearly.
3- If confirmed by the main executor, immediately proceed.