Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study

Efficacy of Sleeve Gastrectomy, MGB, SASI Bypass in Type 2 Diabetes Obese Patients, Comparative Randomized Study

the investigator Randomized and compare the efficacy of 3 types of metabolic surgery in the treatment of type 2 diabetes in obese patients, one of them is SASI bypass which is a modification of Santoro's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first comparative clinical trial as regards the clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2 in Obese
• Intervention / Treatment: Other: metabolic surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: metabolic surgery; operation to cure type2 diabetes; Other Names: diabetic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
excess weight loss	The percent of excess weight loss was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of diabetes	defined in this study as a fasting plasma glucose level < 110 mg/dL or HbA1C level < 6 % without hypoglycemic medication at 1 year after surgery. whereas improvement was defined as a reduction of at least 25% in the fasting plasma glucose level and of at least 1% in the hemoglobin A1c level with hypoglycemic drug treatment	one year

Collaborators and Investigators

• Sponsor: tarek mahdy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 2, 2017

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: QGS1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No