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Completed

NCT Number: NCT04037670

Efficacy of SASI Bypass in Super Obese Patients

Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).

Exclusion criteria

  • Pregnant women.
  • Patients unfit for general anasthesia (ASA 4, 5)
  • Endocrine or psychiatric disorders.
  • History of previous upper abdmominal laparotomy.
  • Alcoholic addiction
  • Liver cirrhosis
  • Coagulopathy

Treatment and study plan

SASI bypass

Procedure

Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction

Primary outcomes

  1. percentage of excess weight loss

    Time frame: at 12 months of follow-up

    [preoperative weight - weight at 12 months]/preoperative excess weight X 100

Secondary outcomes

  1. Resolution of diabetes mellitus

    Time frame: at 12 months of follow-up

    number of patients with fasting plasma glucose level <110 mg/dL or HbA1C level <6% without hypoglycemic medication

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Jul 30, 2019

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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