Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)

Evaluation the efficacy of anterior cruroplasty vs posterior .cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One-Anastomosis Gastric Bypass (OAGB)

Clinical trial, with parallel groups, single-blind, randomized, on 90 patients

This trial will be conducted on 90 patients in Rasool-e Akram hospital. Patients will be blind.

Inclusion criteria: 40<BMI<50, 18<age<65, Primary bariatric surgery OAGB Surgical Procedure, BP Limb of 150 cm, Anastomosis diameter 4 cm Symptomatic clinical GERD before OAGB, GERD grade A, B, C in pre-op endoscopy, Any size of hiatal hernia. Exclusion criteria were: 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, and Barrett's esophagus in pre-op endoscopy.

1- Intervention group: 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 Treitz' ligament. 2- Intervention group: 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 gastrojejunostomy about 150cm distal to Treitz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0. 3- Intervention group: 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 gastrojejunostomy about 150cm distal to Treitz' ligament. Then a posterior cruroplasty is performed with Ethibond 2-0.

Status of Gastroesophageal Reflux

Hello. Respectfully The applied changes are: sample size: 90 (in three groups of 30) - place of study: Rasool-e Akram Hospital

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.

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.