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IRCT20201201049551N1 IRCT 2020-12-08 Ahvaz University of Medical Sciences Comparison of two methods with and without creasing of part of the stomach in patients with morbid obesity Comparison of Roux-en-Y Gastric Bypass techniques with and without distal gastric plication in Patients with morbid obesity referring to the hospitals affiliated to the Jundishapur University of Medical Sciences, Ahvaz during 2019-2020 2020-12-09 anticipated 40 Complete https://irct.ir/trial/52672 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization based on random numbers table, In this way, we put a set of numbers in a completely random order without any pattern or order, set the table numbers to read from above. For intervention group we consider even numbers and for control group we consider individual numbers. Then we place one of the numbers up and down, register the number and assign it to one of the intervention or control groups, Blinding description: First, the study groups are explained to the participants, then, without knowing the name of the group, they enter one of the study groups.Participants and outcome assessors are not aware of any study group names. 2-3 Morbid obesity. Intervention 1: Intervention group: Gastric bypass by distal plication method, in the Roux-en-Y method with distal gastric plication, the gastric puncture is about 25 ml and the biliopancreatic length is 50 cm. That like the standard method,only in this method, the stomach separated from the proximal part is folded together with a number of 2-0 nylon thread.The remaining stomach volume is 25 ml. Intervention 2: Control group: Gastric bypass by standard method without plication, in the Roux-en-Y method with distal gastric plication, the gastric puncture is about 25 ml and the biliopancreatic length is 50 cm First, it is cut transversely to a distance of 5 cm from the GEJ in the form of a gastric tube, then the stomach is cut longitudinally to the cardia with a lumen 3 cm in diameter. The volume of the remaining stomach is 25 ml, which is inserted into the small intestine 80-120 cm in the distal position of the small intestine after anastomosis with the help of 2-0 Continius prolen. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Only available to scholars working in academic and academic institutions Conditions: Employed in research centers Where to obtain: Person responsible for scientific inquiries How to obtain: Send email to person responsible for scientific inquiries Comments:
public Mehdi Askari M.D
Farvardin St.
Ahvaz Iran (Islamic Republic of) 33118-61357 +98 61 3374 3001 askari-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mehdi Askari M.D
Farvardin St.
Ahvaz Iran (Islamic Republic of) 33118-61357 +98 61 3374 3001 askari-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years Obesity with a BMI of more than 35 with comorbidity disease or more than 40 kg / m2 Obesity with comorbidity diseases Patients with consent to participate in the study 18 years 65 years Both Debilitating diseases, including cancer, tuberculosis, AIDS Having diseases that limit patient-physician communication, such as Alzheimer's Recorded history of mental illness (major depression or uncontrolled psychosis) Drug and alcohol abuse Severe heart disease with risk of anesthesia Severe coagulopathy Not accepting nutritional orders History of gastric surgery or antireflux surgery High-grade dysplasia in Barrett's esophagus Severe iron deficiency anemia Distal lesions of the stomach or duodenum require follow-up Patients with no consent to participate in the study Z68. 41 Body mass index (BMI) 40.0-44.9, adult. Treatment - Surgery Treatment - Surgery Intervention group: Gastric bypass by distal plication method, in the Roux-en-Y method with distal gastric plication, the gastric puncture is about 25 ml and the biliopancreatic length is 50 cm. That like the standard method,only in this method, the stomach separated from the proximal part is folded together with a number of 2-0 nylon thread.The remaining stomach volume is 25 ml. Control group: Gastric bypass by standard method without plication, in the Roux-en-Y method with distal gastric plication, the gastric puncture is about 25 ml and the biliopancreatic length is 50 cm First, it is cut transversely to a distance of 5 cm from the GEJ in the form of a gastric tube, then the stomach is cut longitudinally to the cardia with a lumen 3 cm in diameter. The volume of the remaining stomach is 25 ml, which is inserted into the small intestine 80-120 cm in the distal position of the small intestine after anastomosis with the help of 2-0 Continius prolen. Weight Loss. Timepoint: Two weeks, 1,2,6, 12 months after surgery. Method of measurement: The rate of weight loss two weeks after surgery is 4%, 1 month after 8%, 3 months after 18%, 6 months after 30%, 12 months after 40% relative to baseline weight. The amount of ghrelin hormone. Timepoint: Six, 12 months after surgery. Method of measurement: Pg/mL. Ahvaz University of Medical Sciences Approved 2019-11-08 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences, University City Ahvaz Khouzestan Iran (Islamic Republic of)