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IRCT20100609004141N3 IRCT 2018-12-18 Kermanshah University of Medical Sciences Assessing effect of flow rate of CO2 gas on postoperative complications in laparoscopic surgery Assessing effect of flow rate of CO2 gas on postoperative complications in laparoscopic surgery 2018-09-22 anticipated 104 Complete https://irct.ir/trial/36011 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Condition 1: Flow rate of CO2 gas , Postoperative complications in cholecystectomy laparoscopic surgery. Condition 2: Flow rate of CO2 gas , Postoperative complications in herniorafi laparoscopic surgery. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: After the samples being unidentifiable, data is publishable . When: The access period; Starts 6 months after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: People who try to help science can use data. Where to obtain: Expert of Research Unit of Imam Khomeini Hospital in Kermanshah , Sharman Rahmani , sh.rahmani90@yahoo.com How to obtain: 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. Comments:
public Dr Behnam Reza Makhsosy
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
Kermanshah Iran (Islamic Republic of) 6718743161 +98 83 3728 5054 dr.makhsosy@kums.ac.ir Kermanshah University of Medical Sciences scientific Kermanshah University of Medical Sciences
Imam Khomeini hospital in Kermanshah, Naghliye avenue , Kermanshah
Kermanshah Iran (Islamic Republic of) 6718743161 +98 83 3728 5054 dr.makhsosy@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Ages between 18 and 65 years old Have laparoscopic surgery 18 years 65 years Both 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 K81.0 K43 Acute cholecystitis Ventral hernia Treatment - Surgery Treatment - Surgery 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. 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. 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. 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. 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. Kermanshah University of Medical Sciences Approved 2018-06-12 Ethics committee of Kermanshah University of Medical Sciences Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)