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IRCT20201020049087N1 IRCT 2020-11-13 Esfahan University of Medical Sciences Sleeve and Cruroplasty for Preventing De-novo Gastric Reflux 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 2020-11-17 anticipated 170 Complete https://irct.ir/trial/51754 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. N/A Condition 1: severe obesity. Condition 2: Bariatric surgery status. Condition 3: Gastro-esophageal reflux disease without esophagitis. Condition 4: Gastro-esophageal reflux disease with esophagitis. Intervention 1: Intervention group: Concomitant cruroplasty with routine sleeve gastrectomy. The sleeve is performed after releasing the stomach from the surrounding soft-tissue and omentum. Next, parallel to greater curvature, and with a 36 french Bougie in place, the gasterectomy will be performed using staplers. For cruroplasty, the cruses of the diaphragm bring closer with nonabsorbable sutures. Intervention 2: Control group/placebo: Just routine sleeve gastrectomy without cruroplasty. The sleeve is performed after releasing the stomach from the surrounding soft-tissue and omentum. Next, parallel to greater curvature, and with a 36 french Bougie in place, the gasterectomy will be performed using staplers. The cruses of diaphragm will be observed laparoscopically for concealed hiatal hernia, but no cruroplasty with non-absorbable suture will be performed. 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 Shahab Shahabi
Isfahan Minimally Invasive Surgery and Obesity Researhc Center, Alzahra University Hospital, Sofe Blvd. Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746 +98 31 3667 1832 shshahabi@yahoo.com Esfahan University of Medical Sciences scientific Shahab Shahabi
Isfahan Minimally Invasive Surgery and Obesity Researhc Center, Alzahra University Hospital, Sofe Blvd. Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746 +98 31 3667 1832 shshahabi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Have indications for bariatric procedure according to ASMBS guideline (i.e. body mass index>40 kg/m2) Normal gastroesophageal junction view on endoscopy No hiatal hernia on endoscopy H.pylori stool antigen negative No history of gastroesophageal reflux disease symptoms No history of consuming PPIs or antibiotics Willingness to participate in this study Age within 20-60 years old 20 years 60 years Both Not willing to participate in this study Pregnancy during the follow-up Severe or uncontrolled psychological disease Not respecting to the dietician and supplement use protocols Not participating in postoperative follow-up visits Not willing to do postoperative endoscopy >20% lack in medical document data Finding hiatal hernia during the operation E66.01 Z98.84 K21.9 K21.0 Morbid (severe) obesity due to excess calories Bariatric surgery status Gastro-esophageal reflux disease without esophagitis Gastro-esophageal reflux disease with esophagitis Prevention Placebo Intervention group: Concomitant cruroplasty with routine sleeve gastrectomy. The sleeve is performed after releasing the stomach from the surrounding soft-tissue and omentum. Next, parallel to greater curvature, and with a 36 french Bougie in place, the gasterectomy will be performed using staplers. For cruroplasty, the cruses of the diaphragm bring closer with nonabsorbable sutures. Control group/placebo: Just routine sleeve gastrectomy without cruroplasty. The sleeve is performed after releasing the stomach from the surrounding soft-tissue and omentum. Next, parallel to greater curvature, and with a 36 french Bougie in place, the gasterectomy will be performed using staplers. The cruses of diaphragm will be observed laparoscopically for concealed hiatal hernia, but no cruroplasty with non-absorbable suture will be performed. Incidence of GERD clinical manifestations. Timepoint: before-after the surgery. Method of measurement: Taking history of reflux symptoms e.g. heartburn, regurgitation. GERD-Quality of Life questionnaire score. Timepoint: change in score before-after the surgery. Method of measurement: GERD-QL questionnaire. Evidence of reflux in gastroesophageal endoscopy. Timepoint: before-after the surgery. Method of measurement: gastroesophageal endoscopy. Evidence of hiatal hernia in endoscopy. Timepoint: before-after surgery. Method of measurement: upper endoscopy. Esfahan University of Medical Sciences Approved 2020-04-12 isfahan university of medical sciences deputy of ethics in medical research Heza jarib blv. azadi sq. isfahan Isfehan Iran (Islamic Republic of)