Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study
Keywords
Abstract
Description
from 2011 to 2017, investigators Randomized and collect data for the 3 operations SASI bypass , Mini gastric bypass and Sleeve gastrectomy ) about thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude gall stones and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity complications and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 12/28/2017 |
| Estimated Enrollment Submitted: | 01/04/2018 |
| First Posted: | 01/08/2018 |
| Last Update Submitted: | 06/29/2020 |
| Last Update Posted: | 07/01/2020 |
| Actual Study Start Date: | 12/31/2010 |
| Estimated Primary Completion Date: | 10/31/2017 |
| Estimated Study Completion Date: | 12/01/2017 |
Condition or disease
Intervention/treatment
Other: Diabetes Mellitus Type 2 in Obese patients
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: Diabetes Mellitus Type 2 in Obese patients obese patients had metabolic surgery for the treatment for DMT2 .Preoperative data , which including SASI bypass , MGB and Sleeve gastrectomy | Other: Diabetes Mellitus Type 2 in Obese patients operation to cure type2 diabetes |
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: Type 2 diabetic obese patients Exclusion Criteria: - patients age above 65 or below 18 years old - history of upper laparotomy - unfit for anesthesia or laparoscopy - major psychological instability - drug abuse |
Outcome
Primary Outcome Measures
1. excess weight loss [one year]
Secondary Outcome Measures
1. Resolution of diabetes [one year]
