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IRCT20190325043107N39 IRCT 2023-12-09 Tabriz University of Medical Sciences Comparison of results of single-anastomosis gastric bypass with biliopancreas in patients with class 3 obesity Comparison of the results of single-anastomosis gastric bypass with 150 and 180 cm biliopancreas in patients with class 3 obesity 2024-01-19 anticipated 80 Complete https://irct.ir/trial/74035 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method in order to balance the number of allocated samples, and with 4 people in each block, the whole block We put the possible ones as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose from numbers one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will be divided into two intervention groups (group A) and control group (group B), Blinding description: The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of equipment used, in this study they will not know what type of equipment will be used in other patients. 2-3 Body mass index changes. Intervention 1: Intervention group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 150 cm, and then the body mass index will be measured for one year after the surgery and once every three months. Intervention 2: Control group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 180 cm, and then the body mass index will be measured for one year after the surgery and once every three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Class III obesity (body mass index above 40) Candidate for gastric bypass surgery Surgery performed by a single surgeon Consent to participate in the study 18 years 65 years Both Previous surgery on the stomach Patients with gastrointestinal cancers Patients with metabolic problems Patients receiving any type of multivitamin due to systemic problems Z68.35 Body mass index (BMI) 35.0-35.9, adult Treatment - Surgery Treatment - Surgery Intervention group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 150 cm, and then the body mass index will be measured for one year after the surgery and once every three months. Control group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 180 cm, and then the body mass index will be measured for one year after the surgery and once every three months. Body mass index changes. Timepoint: Once every three months for one year after surgery. Method of measurement: Weight measuring scale and meter for measuring height. Tabriz University of Medical Sciences Approved 2023-10-15 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)