Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03394157
Enrollment
800
Registered
2018-01-09
Start date
2011-01-31
Completion date
2017-12-02
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI

Brief summary

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.

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.

Interventions

OTHERmetabolic surgery

operation to cure type2 diabetes

Sponsors

tarek mahdy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
excess weight lossone yearThe percent of excess weight loss was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.

Secondary

MeasureTime frameDescription
Resolution of diabetesone yeardefined 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026