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IRCT20190128042520N4 IRCT 2022-11-23 Iran University of Medical Sciences Evaluation the efficacy of diaphragmatic hernia repair in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB) Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB) 2023-01-20 anticipated 90 Complete https://irct.ir/trial/66924 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 30 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 90 random allocations for use in the first phase of the study will be kept by the main investigator, Blinding description: The patients are not aware about the type of surgery, but all types will describe before performing surgery and the aim of study completely clarify for them. This issue that the efficacy of these three methods on postoperative reflux is unknown, completely describe for the patients and they include in study after obtaining the informed consent. N/A Gastro-esophageal reflux disease. Intervention 1: Intervention group 1: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Intervention 2: Intervention group 2: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0. Intervention 3: Intervention group 3: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0. 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 Mohammad Kermansaravi
No 17, 3th Morvarid, 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, 3th Morvarid, Sadaf Ave, Dadman Blvd, Qods Town
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8809 5451 kermansaravi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 40<BMI<50 18<age<65 Primary surgery OAGB Surgery Biliopancreatic limb length of 150 cm Anastomosis length of 4 cm Symptomatic clinical reflux before surgery Reflux grade A, B, C in endoscopy Having hiatal hernia in any size 18 years 65 years Both High risk of anesthesia after heart and lung counseling Diagnosing the surgeon based on the high risk of surgery Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist Barrett's esophagus in pre-op endoscopy K21 Gastro-esophageal reflux disease Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group 1: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Intervention group 2: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0. Intervention group 3: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0. Gastroesophageal Reflux Disease. Timepoint: Before surgery and 7 months after surgery. Method of measurement: Upper GI Endoscopy (esophagogastroduodenoscopy). Iran University of Medical Sciences Approved 2022-11-16 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)