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IRCT20100609004141N2 IRCT 2018-12-14 Kermanshah University of Medical Sciences Assessing effect of endo-bag on the complications of cholecystectomy laparoscopic surgery Assessing effect of endo-bag on the complications of cholecystectomy laparoscopic surgery 2018-08-01 anticipated 160 Complete https://irct.ir/trial/35606 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 endo-bag or non endo-bag 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 Effect of endo-bag on the complications of cholecystectomy laparoscopic surgery. Intervention 1: Intervention: The intervention in this study is applying the endo-bag. Endo-bag is a gadget, like a bag that can be inserted into the surgical wound and it can be opened and closed with control from the outside of the abdomen. Surgeon putting the endo-bag (when is closed) into the patient's abdomen and opens it at the surgical site with special lever. Then the contents of the surgery, which is high volume and can not be removed from Laparoscopic small incision it is placed in the endo-bag and is brought to a nearby surgical site and fragmentary going out. Intervention group are patients who eligible for inclusion in the study and without knowing about their surgery have with endo-bag or without endo-bag. Then surgery with endo-bag applied to them. Intervention 2: Control group are patients who eligible for inclusion in the study and without knowing about their surgery have with endo-bag or without endo-bag. Then surgery without endo-bag applied to them. 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 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 Iran (Islamic Republic of) Having an acute gall bladder infection problem Ages between 18 and 65 years old 18 years 65 years Both History of cystectomy surgery Having liver cirrhosis Treatment - Surgery Treatment - Surgery Intervention: The intervention in this study is applying the endo-bag. Endo-bag is a gadget, like a bag that can be inserted into the surgical wound and it can be opened and closed with control from the outside of the abdomen. Surgeon putting the endo-bag (when is closed) into the patient's abdomen and opens it at the surgical site with special lever. Then the contents of the surgery, which is high volume and can not be removed from Laparoscopic small incision it is placed in the endo-bag and is brought to a nearby surgical site and fragmentary going out. Intervention group are patients who eligible for inclusion in the study and without knowing about their surgery have with endo-bag or without endo-bag. Then surgery with endo-bag applied to them Control group are patients who eligible for inclusion in the study and without knowing about their surgery have with endo-bag or without endo-bag. Then surgery without endo-bag applied to them. 1- Pain due to laparoscopic cholecystectomy2- Duration of surgery for laparoscopic cholecystectomy3- Collection of Morrison area in laparoscopic cholecystectomy4- Wound infection after laparoscopic cholecystectomy5- Ileus after laparoscopic cholecystectomy. Timepoint: Immediately after surgery and up to 3 months after surgery. Method of measurement: Visual Assessment Scale of Pain 0-10. Kermanshah University of Medical Sciences Approved 2018-07-24 Ethics committee of Kermanshah University of Medical Sciences Deputy of Research and Technology , Shahid Beheshti Blvd, Building No. 2 , Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)