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IRCT20190128042520N2 IRCT 2020-06-22 Iran University of Medical Sciences the effect of Carbajo's surgical technique on bile reflux Comparing the effect of Laparoscopic One Anastomosis Gastric Bypass and Carbajo’s gastric bypass on incidence of bile reflux in morbid obese patients: a randomized controlled clinical trial 2020-06-21 anticipated 74 Complete https://irct.ir/trial/48668 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups using four randomized blocks. One of the statistical specialists who is not present in the project is responsible for randomly assigning individuals to the two groups after examining the achievement of admission criteria. (One of the two methods mentioned above), he is contacted and he tells us the type of surgery that is going to be performed, Blinding description: The patient is not aware of his surgical procedure, but we will explain to him about these two methods, and the purpose of this study will be explained to him. They are explained and after obtaining informed consent, they enter the study. In this study, the doctor who performs the surgery is definitely aware of the surgical procedure. To minimize the surgeon's awareness error, the doctor who evaluates the reflux is different from the surgeon, but despite this, the study is considered single blind. 3 morbid obesity. Intervention 1: 1- Typical one-anastomosis bypass method: In the distal area, we enter the crow's foot to crow's foot, and on the 36 F bougie, using a few 60 mm endo staplers with a suitable staple height, the stomach pouch is made long and narrow. In the next step, gastrojejunal anastomosis is performed with 45 mm blue stapler and the intestinal site is sutured with 2-0 PDS sutures from 150 to 200 cm depending on BMI, age, height and comorbidities. Intervention 2: 2. Single anastomosis bypass with Carbajo technique: In Carbajo method, the steps are the same as traditional method and only a few differences are seen: 1- The length of the pouch is 13 to 15 cm. 2. Gastrojejunal anastomosis is 2 to 2.5 cm. 3. The length of the biliopancreatic limb is 250 to 350 cm on average. 4. The proximal portion of the gastrojejunal anastomosis is 8 to 10 cm long and sewn to the pouch and then to the remnant in the opposite direction of gravity. No - There is not a plan to make this available Justification or reason for not sharing IPD is etics
public Mohammad Kermansaravi
No 17 ،Morvarid 3،Sadaf Ave،Dadman Blvd،Qods Town
Tehran Iran (Islamic Republic of) 1445613131 +98 21 8809 5451 kermansaravi.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Kermansaravi
No 17 ،Morvarid 3،Sadaf Ave،Dadman Blvd،Qods Town
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 8809 5451 kermansaravi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) BMI≥40 BMI ≥35> 40 with at least one obesity-related complication with failure of conventional non-surgical treatments BMI ≥30 with diabetes with recent onset Acceptable surgical risk Complete and sign the informed consent of the company to participate in the study and commit to return for further follow-up OAGB or Carbajo surgery no limit no limit Both Obesity due to treatable endocrine diseases such as Cushing's • High risk of anesthesia after heart and lung counseling • Diagnosing the surgeon based on the high risk of surgery • Drug addiction • Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist Pregnancy or pregnancy planning for the next two years in married women of childbearing age Severe preoperative reflux: GERD Score greater than or equal to eight according to the GERD Q questionnaire Severe to moderate severe or severe herniated epilepsy according to endoscopy K21 Gastro-esophageal reflux disease Treatment - Surgery Treatment - Surgery 1- Typical one-anastomosis bypass method: In the distal area, we enter the crow's foot to crow's foot, and on the 36 F bougie, using a few 60 mm endo staplers with a suitable staple height, the stomach pouch is made long and narrow. In the next step, gastrojejunal anastomosis is performed with 45 mm blue stapler and the intestinal site is sutured with 2-0 PDS sutures from 150 to 200 cm depending on BMI, age, height and comorbidities 2. Single anastomosis bypass with Carbajo technique: In Carbajo method, the steps are the same as traditional method and only a few differences are seen: 1- The length of the pouch is 13 to 15 cm. 2. Gastrojejunal anastomosis is 2 to 2.5 cm. 3. The length of the biliopancreatic limb is 250 to 350 cm on average. 4. The proximal portion of the gastrojejunal anastomosis is 8 to 10 cm long and sewn to the pouch and then to the remnant in the opposite direction of gravity. GastroEsophageal Reflux Disease. Timepoint: 12 months after surgery. Method of measurement: Cintigraphy after assessment of GERD-Q (gastroesophageal reflux disease questionnaire) equal or more than 8. Iran University of Medical Sciences Approved 2020-05-10 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway tehran Tehran Iran (Islamic Republic of)