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

Sponsor
tarek mahdy (Other)
Overall Status
Completed
CT.gov ID
NCT03394157
Collaborator
(none)
800
Enrollment
1
Arm
83
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: metabolic surgery
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
800 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Sleeve Gastrectomy, MGB, SASI Bypass in Type 2 Diabetes Obese Patients, Comparative Randomized Study
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Dec 2, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. excess weight loss [one year]

      The percent of excess weight loss was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.

    Secondary Outcome Measures

    1. Resolution of diabetes [one year]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • tarek mahdy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    tarek mahdy, professor of Bariatric and Metabolic surgery, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT03394157
    Other Study ID Numbers:
    • QGS1101
    First Posted:
    Jan 9, 2018
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by tarek mahdy, professor of Bariatric and Metabolic surgery, Mansoura University
    sleeve gastrectomy , MGB , type 2 diabetes , obesity , SASI
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jul 2, 2020