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IRCT20180507039572N1 IRCT 2021-02-13 Iran University of Medical Sciences The effect of gasterojejunal anastomosis size on Excess Body Mass Index Loss (EBMIL) and Roux-en-Y bypass outcomes The effect of 30 and 45 mm gasterojejunal anastomosis size with fixed 125 cm biliopancreatic limb and 75 cm alimentary limb on Excess Body Mass Index Loss (EBMIL) and Roux-en-Y bypass outcomes in the patients with morbid obesity; a double- blinded clinical trial 2021-03-05 anticipated 70 Complete https://irct.ir/trial/53452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, we will create random numbers in a column, so the Rand () function in Excel will be used. Then we will consider the random numbers below the half as 4 blocks and the numbers above the half as 6 blocks. For this purpose, the symbols O30 and O45 have been used for 30 and 45 mm interventions. The procedure is as follows: in block 4, two O30 interventions and two O45 interventions will be written in a column first. More column will then be assigned 4 random numbers using the Rand () function. The order of the assigned random numbers will then be sorted from small to large to change the order of our intervention codes. The same thing will be repeated for a block of 6. This process continues until we reach an equal number of control and intervention groups. After generating random numbers without repetition, a number is assigned to each assigned sequence along with the type of intervention, and will be placed in a sealed envelope whose contents are not known, so that the operating room nurse will pick up one of the 70 envelopes for qualified patient and will inform the type of group to surgeon after tearing the sealed envelope, Blinding description: Patients and outcome assessors will be unaware of the allocated study groups. Due to the fact that the intervention is necessarily performed by the surgeon, so there is no possibility of blinding the surgeon and the surgeon is aware of the group type. N/A Condition 1: Diabetes. Condition 2: Morbid obesity. Intervention 1: Intervention 1 "Receiving 45 mm gasterojejunal anastomosis": Patients in this group will be placed in French (Y-shaped) surgical position after general anesthesia so that the surgeon can stand between the patient's legs. Five trocas will be used to perform Roux-en Y bariatric laparoscopy. The first optical troca (with camera) is placed 10 cm from the xiphoid process in the medline line, and then the other two trocas will be placed to the right (10 mm) and left (5 mm) of the medline line. Also, two 5 mm trocas will be placed at the bottom of the umbilicus at a distance of approximately 20 cm from each other. The "Angle of His" between the stomach and esophagus is released. After implanting a gastric pouch that is 6 cm long with an approximate volume of 30 to 60 ml, 125 cm from the proximal part of the small intestine will be calculated to prepare it for anastomosis with a 45 mm gastric linear stapler and then 75 cm from the distal part to the gasterojejunostomy site, a hole will be made to make a gasterojejunal anastomosis. Intervention 2: Intervention 2 "Receiving 30 mm gasterojejunal anastomosis": Patients in this group will be placed in French (Y-shaped) surgical position after general anesthesia so that the surgeon can stand between the patient's legs. Five trocas will be used to perform Roux-en Y bariatric laparoscopy. The first optical troca (with camera) is placed 10 cm from the xiphoid process in the medline line, and then the other two trocas will be placed to the right (10 mm) and left (5 mm) of the medline line. Also, two 5 mm trocas will be placed at the bottom of the umbilicus at a distance of approximately 20 cm from each other. The "Angle of His" between the stomach and esophagus is released. After implanting a gastric pouch that is 6 cm long with an approximate volume of 30 to 60 ml, 125 cm from the proximal part of the small intestine will be calculated to prepare it for anastomosis with a 30 mm gastric linear stapler and then 75 cm from the distal part to the gasterojejunostomy site, a hole will be made to make a gasterojejunal anastomosis. Yes - There is a plan to make this available What will be shared: All patient's data will be provided anonymously to researchers. The findings of the study will be presented publicly. When: Immediately after the publication of the article To whom: Academic researchers and faculty members Conditions: For research purposes only Where to obtain: ٍEmail must be sent to the responsible for scientific inquiries (msdodran@gmail.com) How to obtain: ٍEmail must be sent to the responsible for scientific inquiries (msdodran@gmail.com) Comments:
public Rohollah Valizadeh
Hazrat-e-Rasoul Hospital, Sattar Khan Ave.
Tehran Iran (Islamic Republic of) 1916737183 +98 21 8670 5512 rohvali4@gmail.com Iran University of Medical Sciences scientific Rohollah Valizadeh
Hazrat-e-Rasoul hospital, Sattar Khan Ave.
Tehran Iran (Islamic Republic of) 1916737183 +98 21 8670 5512 rohvali4@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Candidate for Roux-en Y surgery Satisfaction to participate in the study Age over 18 years Body mass index more or equal to 40 and less or equal to 50 18 years 75 years Both History of major gastrointestinal surgery Having general conditions that prevent surgery under general anesthesia Age over 75 years Having Crohn's inflammatory disease Family history of gastric cancer Severe intestinal adhesions E08 E66.01 Diabetes mellitus due to underlying condition Morbid (severe) obesity due to excess calories Treatment - Surgery Treatment - Surgery Intervention 1 "Receiving 45 mm gasterojejunal anastomosis": Patients in this group will be placed in French (Y-shaped) surgical position after general anesthesia so that the surgeon can stand between the patient's legs. Five trocas will be used to perform Roux-en Y bariatric laparoscopy. The first optical troca (with camera) is placed 10 cm from the xiphoid process in the medline line, and then the other two trocas will be placed to the right (10 mm) and left (5 mm) of the medline line. Also, two 5 mm trocas will be placed at the bottom of the umbilicus at a distance of approximately 20 cm from each other. The "Angle of His" between the stomach and esophagus is released. After implanting a gastric pouch that is 6 cm long with an approximate volume of 30 to 60 ml, 125 cm from the proximal part of the small intestine will be calculated to prepare it for anastomosis with a 45 mm gastric linear stapler and then 75 cm from the distal part to the gasterojejunostomy site, a hole will be made to make a gasterojejunal anastomosis. Intervention 2 "Receiving 30 mm gasterojejunal anastomosis": Patients in this group will be placed in French (Y-shaped) surgical position after general anesthesia so that the surgeon can stand between the patient's legs. Five trocas will be used to perform Roux-en Y bariatric laparoscopy. The first optical troca (with camera) is placed 10 cm from the xiphoid process in the medline line, and then the other two trocas will be placed to the right (10 mm) and left (5 mm) of the medline line. Also, two 5 mm trocas will be placed at the bottom of the umbilicus at a distance of approximately 20 cm from each other. The "Angle of His" between the stomach and esophagus is released. After implanting a gastric pouch that is 6 cm long with an approximate volume of 30 to 60 ml, 125 cm from the proximal part of the small intestine will be calculated to prepare it for anastomosis with a 30 mm gastric linear stapler and then 75 cm from the distal part to the gasterojejunostomy site, a hole will be made to make a gasterojejunal anastomosis. Excess Body Mass Index Loss (EBMIL). Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Using the following formula obtained from the body mass index: (Pre-operative BMI – Current BMI) / (Pre-operative BMI – 25) × 100. Diabetes remission. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Using Buchwald criteria (FPG <100 mg/dl or A1C <6 %). Insulin. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Fasting blood sugar. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Glocuse, 2 hour Post Prandial. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. C-Peptide. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. HbA1C. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Lipid profile. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Systolic blood presser. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Barometer. Diastolic blood pressure. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Barometer. Dumping. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Physical examination. Hemoglobin. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Liver porfile. Timepoint: Before the intervention, one, three and six months after the intervention. Method of measurement: Blood sampling. Quality of life. Timepoint: Six months after the intervention. Method of measurement: BAROS quality of life consisting of 5 items (self-esteem, work conditions, physical activity, social activity and sexual Activity). Each item consists of 5 options (much better, better, similar, worse and much worse). Iran University of Medical Sciences Approved 2021-02-09 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences., next to Milad tower., Hemmat highway Tehran Tehran Iran (Islamic Republic of)