Status
Conditions
Treatments
About
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
Full description
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 (as a primary outcome), PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
SASJ Group: composed of 20 patients undergoing SASJ operation. - OAGB Group: composed of 20 patients undergoing OAGB operation.
Convenience sampling was used and the sample size was 40 patients. An informed consent was taken from all patients and all data are confidential, and patients will not be mentioned by name in any published paper. Patients will have the right to refuse joining the research or withdraw at any time without affecting their chance to receive the traditional therapy at any time.
Regarding the Study Procedures, all patients will have preoperative workup including full history taking, general and local examination, laboratory profile including complete blood picture, liver function tests, kidney function tests, clotting profile, fasting and 2-hour postprandial blood glucose, HbA1C, serum insulin level, C-peptide (in non-insulin receiving patients) and Viral markers. Also Serum levels of GLP-1, PYY and GIP, thyroid profile (Free T3, T4 and TSH), pelviabdominal US, and upper GI endoscopy in patients with GERD or when an intra-gastric pathology is suspected. Cardiopulmonary assessment could be done if clinically indicated.
Operative details - One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. A transverse anastomosis is usually done.
Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigators will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus.
Regarding postoperative follow up, routine follow up visits will be arranged after one month, 3 months and 6 months. Also serum levels of GLP-1, PYY and GIP will be measured 6-8 weeks post-operative. In each visit patient will have full clinical assessment including glycemic control especially HbA1c levels, fasting blood glucose levels, post prandial serum glucose levels, serum insulin levels, C peptide levels (in non-insulin receiving patients), weight loss rate and total weight loss percentage calculated with nutritional parameters like serum calcium, iron, albumin, vitamin D and PTH will be assessed once after 6 months.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal