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IRCT20100609004141N4 IRCT 2019-07-18 Kermanshah University of Medical Sciences Comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair Comparison of recurrence and postoperative complications between open and laparoscopic surgical procedures ventral hernia repair 2019-07-23 anticipated 120 Complete https://irct.ir/trial/40835 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 Ventral hernia. Intervention 1: The intervention is the type of surgery. Intervention group1: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing laparoscopic surgery. Laparoscopic surgery is a type of surgery in which, a thin, luminous tube is placed inside a cut in the abdomen or pelvis so that the surgeon can see the patient's part without breaking the member and then heal it. Intervention 2: The intervention is the type of surgery. Intervention group2: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing open surgery. Open surgery is a type of surgical procedure in which the skin and muscles are completely cracked and opened so that the surgeon can see the patient's part with the eye and then heal it. 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) Ages between 18 and 65 years old Have ventral hernia surgery by laparoscopic method Have ventral hernia surgery by open method 18 years 65 years Both Emergency hernia Factors that increase intra-abdominal pressure, such as COPD Too much obesity BPH Pregnancy K43.9 Ventral hernia without obstruction or gangrene Treatment - Surgery Treatment - Surgery The intervention is the type of surgery. Intervention group1: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing laparoscopic surgery. Laparoscopic surgery is a type of surgery in which, a thin, luminous tube is placed inside a cut in the abdomen or pelvis so that the surgeon can see the patient's part without breaking the member and then heal it. The intervention is the type of surgery. Intervention group2: Patients who are eligible for inclusion in the study are included in the study and without knowing , they are undergoing open surgery. Open surgery is a type of surgical procedure in which the skin and muscles are completely cracked and opened so that the surgeon can see the patient's part with the eye and then heal it. Infection caused by laparoscopy and open surgery. Timepoint: 1: 6 weeks after surgery 2: 6 ± 15 months after surgery. Method of measurement: By observing the patient. Hematoma caused by laparoscopy and open surgery. Timepoint: 1: 6 weeks after surgery 2: 6 ± 15 months after surgery. Method of measurement: By observing the patient. Skin necrosis caused by laparoscopy and open surgery. Timepoint: 1: 6 weeks after surgery 2: 6 ± 15 months after surgery. Method of measurement: By observing the patient. Seroma caused by laparoscopy and open surgery. Timepoint: 1: 6 weeks after surgery 2: 6 ± 15 months after surgery. Method of measurement: By observing the patient. Duration of hospitalization after laparoscopic and open surgery. Timepoint: After surgery until discharge. Method of measurement: Duration of patient admission in hours, in hospital after surgery. Time to feel pain after laparoscopy and open surgery. Timepoint: Immediately after surgery. Method of measurement: The number of minutes someone has pain after the surgery. Time to return to work after laparoscopic and open surgery. Timepoint: Immediately after surgery. Method of measurement: The number of hours that a person will need to return to his head after surgery. Kermanshah University of Medical Sciences Approved 2019-04-24 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)