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Completed

NCT Number: NCT05591833

Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

to compare the results of SASI to SAS-J in treatment of morbid obesity

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia university hospital

Minya, 61511, Egypt

About this study

200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study

Exclusion criteria

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 60
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • revisional bariatric procedures

Treatment and study plan

SASI

Procedure

Single-Anastomosis Sleeve ileal (SASI) Bypass

SAS-J

Procedure

Single-Anastomosis Sleeve Jejunal (SAS-J) Bypass

Primary outcomes

  1. nutritional deficiency

    Time frame: 12 months

    the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)

Secondary outcomes

  1. comorbidities

    Time frame: 1 year

    change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

  2. complications

    Time frame: 1 year

    early and late complications

  3. weight loss

    Time frame: 12 months

    the effect of the 2 procedures on weight measured by percentage of excess weight loss

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2022
Registry last updated
Sep 22, 2023

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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