]>
IRCT20231201060232N1 IRCT 2024-01-09 Kashan University of Medical Sciences Evaluation of the effect of anti-reflux suture in gastric bypass single anastomosis in order to prevent biliary reflux Evaluation of the effect of anti-reflux suture in gastric bypass single anastomosis in order to prevent biliary reflux 2024-01-21 anticipated 60 Complete https://irct.ir/trial/74604 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Sampling is done by a simple random method and randomization is done using a table of random numbers, Blinding description: This study is a double blind study, the first person collects the information and the second person analyzes the information, in such a way that the researcher in charge of the project randomly divides the people into 2 groups 1 and 2 and the list of two It provides the group with the person who collects the information and the person who analyzes the information. N/A Antireflux suture; gastric bypass single anastomosis (oagb) ; biliary reflux. Intervention 1: Intervention group: In omega bypass surgery (OAGB) , after creating a stomach pouch and performing gastrojejunostomy anastomosis and leak test (by air and methylene blue), an antireflux suture is applied in such a way that the proximal part of the small intestine efferent loop is left to the lowest part of the remaining stomach with a non-absorbable thread. Finally, a drain is placed for the patient and the patient's skin is sutured and the operation is finished. Intervention 2: Control group: In omega bypass surgery, after creating a stomach pouch and performing a gastrojejunostomy anastomosis and leakage test (by air and methylene blue), a drain is placed for the patient and the patient's skin is sutured and the operation ends. for the patients of this group, antireflux suture is not applied. Yes - There is a plan to make this available What will be shared: All study data can be provided except for demographic data. When: After performing statistical analysis and determining the relationship between the variables, it can be presented. To whom: The study data is accessible to all people on the condition of receiving approval from the university's ethics committee. Conditions: The people who receive the data must obtain permission to access the data from the ethics committee. There are no restrictions in terms of performing tests and statistical analyses. Where to obtain: The documents and findings of the study will be published in the form of an article and will be accessible in databases, and since the study is a thesis, it will also be accessible in Kashan University of Medical Sciences. How to obtain: The applicant should submit a request for access to the data by submitting an official request from an official body to the ethics committee of Kashan University of Medical Sciences. Comments:
public Fateme Zare Rahimi Abadi
Kashan University of Medical Sciences , Ghotbe Ravandi Ave , kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 35 3726 6742 Fzarefzr@gmail.com Kashan University of Medical Sciences scientific Fateme Zare Rahimi Abadi
Kashan University of Medical Sciences , Ghotbe Ravandi Ave , kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 35 3726 6742 Fzarefzr@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Clients aged 20 to 50 years Having a BMI above 30 Patient satisfaction 20 years 50 years Both Non-cooperation of the patient to participate in the intervention People who consume alcohol and smoke Diseases o Diseases of the digestive system Prevention Prevention Intervention group: In omega bypass surgery (OAGB) , after creating a stomach pouch and performing gastrojejunostomy anastomosis and leak test (by air and methylene blue), an antireflux suture is applied in such a way that the proximal part of the small intestine efferent loop is left to the lowest part of the remaining stomach with a non-absorbable thread. Finally, a drain is placed for the patient and the patient's skin is sutured and the operation is finished. Control group: In omega bypass surgery, after creating a stomach pouch and performing a gastrojejunostomy anastomosis and leakage test (by air and methylene blue), a drain is placed for the patient and the patient's skin is sutured and the operation ends. for the patients of this group, antireflux suture is not applied. GERD score. Timepoint: 2 weeks, one month, 3 month and 6 month after the surgery. Method of measurement: Gastroesophageal reflux disease questionnaire. Kashan University of Medical Sciences Approved 2023-12-25 Ethics committee of Kashan University of Medical Sciences Kashan university of medical sciences, Ghotbe Ravandi Blv., Kashan, Isfahan Kashan Isfehan Iran (Islamic Republic of)