The Role of Sleeve Gastrectomy in Dyslpidemia

NCT03126240 | Unknown DMC

• 1 other identifier: sleeveindyslipedemia
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The increasing prevalence of obesity noticed in recent decades is a major public health problem of pandemic nature. According to researches, there will be 2.3 billion overweight adults and more than 700 million people suffering from obesity worldwide by the year 2020.Series of epidemiologic studies has revealed a relative link between morbid obesity and metabolic syndrome type 2 diabetes mellitus, hypertension, hyperlipidemia, insulin resistance and shorter life span. Dyslipidemia specially when combined with obesity significantly increase the incidence of atherosclerosis and its complications and also insulin resistance and hence control of diabetic patients. Hyperlipidemia is widely recognized as one of the main co- morbidities in severe obesity and major risk factor for development of atherosclerosis and then heart related diseases.Bariatric surgery has become a prominent treatment modality after the rapidly increasing prevalence of obesity.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Low density lipoprotein

  lipid profile

  at 6 months postoperative

Secondary Outcomes (5)

• Low density lipoprotein

  at 1 year postoperative

• Total cholesterol level

  at 6 months postoperative

• Total cholesterol level

  at 1 year postoperative

• High density lipoprotein

  at 6 months postoperative

• High density lipoprotein

  at 1 year postoperative

Study Arms (1)

sleeve Gastrectomy

This is a five-trocar technique. The abdominal cavity is accessed through a 1cm supraumbilical incision using an optical trocar. The operating ports are inserted under direct vision. The gastroesophageal (GE) junction is exposed. A point on the greater curvature approximately 3-6cm to the pylorus is identified as the distal extent of the resection. Ultrasonic shears are used to divide the vessels long the greater curve up to the angle of His. Linear cutting staplers are used to vertically transect the stomach, creating a narrow gastric tube with. A 19Fr drain is placed in the subhepatic space near the staple line. The resected portion of the stomach is extracted through one of the working ports.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Twenty obese patients with an abnormal lipid profile not responding to conservative management will be enrolled in this study

You may qualify if:

• Have BMI \> 40
• Have BMI \> 35 with co-morbidities.
• Signed a well informed and signed written consent.
• Patients with abnormal lipid profile
• Patients failed in trials of conservative management including dietary control regarding lipid profile

You may not qualify if:

• Endocrine disease
• Severe uncontrolled heart disease
• Inability to follow instruction
• Drug abuse, and cancer

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed Mohie Eldin, MBBC

  Specialist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Mohie Eldin, MBBC

CONTACT

+201062233321; ahmed_mohie@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: June 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 24, 2017

Record last verified: 2017-04