Evaluating the Effectiveness of Concomitant Cruroplasty with Sleeve Gasterectomy for Preventing De-novo Gastric Reflux after Sleeve in Patients with Severe Obesity in Comparison to Control Group Who Will Recieve The Only Sleeve Gasterectomy

Evaluating and comparison of the incidence of de-novo GERD and de-novo hiatal hernia after concomitant cruroplasty and sleeve gasterectomy with the sleeve gastrectomy alone. Evaluating and comparison of the mean of GERD-QL Questionaire score after concomitant cruroplasty and sleeve gasterectomy with sleeve gastrectomy itself.

Single-blinded randomized controlled parallel clinical trial

This study is going to be conducted as a single-blinded randomized controlled parallel clinical trial in Isfahan center of excellence for bariatric surgery on patients with severe obesity and otherwise health and evaluate the preventing effects of concomitant cruroplasty with sleeve gasterectomy on postoperative gastric reflux

Patient with severe obesity who are a candidate for bariatric surgery without any sign and symptoms for gastric reflux without any history of it and with consuming no PPIs drugs, and without any clinical evidence of GERD and hiatala hernia in endoscopy who are willing to participate in this study and will complete all the postoperative evlautions and visitis including postoperative endoscopy.

Intervention: Routine sleeve gastrectomy with concomitant cruroplasty Control/Placebo: Just routine sleeve gastrectomy without cruroplasty

Incidence of de-novo gastric reflux after sleeve gasterectomy by asking clinical symptoms of GERD (e.g. heartburn and regurgitation), esophagitis and hiatal hernia in endoscopy, and filling the GERD-QL questionaire.

Recruiting was expected to start after confirmation of trial and receiving the registration code. Because the approval was issued sooner, we started recruiting sooner than what has been estimated.

The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selecting process, and pre- and post-operative assessments. The block size will be equal and is set to 2, the sufficient and estimated sample size will be 170, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope and give it to the surgeon at the time of surgery.

Cruroplasty will be performed at the end of sleeve gasterectomy while patient is under anesthesia. After the randomization process and defining the group of patients, the analytics say the group only to the surgeon and the surgeon who is involved in selecting patients and assessing outcomes will know about the group. Although the patient will be informed about the probability of receiving cruroplasty or not, is blinded during the surgery because of anesthesia.