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

Investigating 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

A clinical trial with parallel, double-blind, randomized by permuted block randomization, performed on 70 patients in the two equal groups.

This study will be carried out on 70 patients who are candidates for bariatric surgery by Roux-en-Y method in Hazrat-e-Rasoul Akram and Atiyeh hospitals in Tehran. The two groups with gasterojejunal anastomosis sizes of 30 and 45 mm will be randomly assigned to the study groups. The randomization method is permuted block randomization.

Inclusion criteria: 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. Exclusion criteria: 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

Intervention group 1 (second surgical technique): Recipient of gasterojejunal anastomosis with a size of 45mm: Intervention group 2 (second surgical technique): Recipient of gasterojejunal anastomosis with a size of 30 mm

Excess Body Mass Index Loss (EBMIL), diabetes remission, HOMA-IR, FBS, 2HPP, C-Peptide, HbA1C, lipid profile, liver profile, systolic and diastolic blood pressure, dumping, hemoglobin and albumin

Modification in sample size

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.

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.

All patient's data will be provided anonymously to researchers. The findings of the study will be presented publicly.

Immediately after the publication of the article

Academic researchers and faculty members

For research purposes only

ٍEmail must be sent to the responsible for scientific inquiries (msdodran@gmail.com)

ٍEmail must be sent to the responsible for scientific inquiries (msdodran@gmail.com)