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Completed

NCT Number: NCT03394157

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metabolic surgery

Other

operation to cure type2 diabetes

Other names: diabetic surgery

Primary outcomes

  1. excess weight loss

    Time frame: one year

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

Secondary outcomes

  1. Resolution of diabetes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

tarek mahdy

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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