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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394157
Other study ID # QGS1101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date December 2, 2017

Study information

Verified date June 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date December 2, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
metabolic surgery
operation to cure type2 diabetes

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
tarek mahdy

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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