The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

NCT ID: NCT04127370

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-11-01

Brief Summary

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The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Detailed Description

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The overall global prevalence of Nonalcoholic Fatty Liver Disease diagnosed by imaging is around 25.24%. The highest prevalence of NAFLD is reported from the Middle East 31.79% and South America 30.45% whereas the lowest prevalence rate is reported from Africa 13.48%.

Unlike NAFLD, Nonalcoholic steatohepatitis is more aggressive and is associated with a risk of approximately 10 to 29% of progression to cirrhosis within10 years. Therefore, early-stage NASH represents a group of patients that is most likely to benefit from treatments in order to prevent progression to cirrhosis and its complications. Obesity is the most common and well documented risk factor for NAFLD, the majority (\>95%) of patients with severe obesity undergoing bariatric surgery will have NAFLD. To date, weight loss achieved via lifestyle intervention remains the mainstay of treatment of NASH.

Bariatric surgery contributes to weight loss in two main ways: restrictive procedures and malabsorptive procedures.

In 2018, the AASLD board stated that it is premature to consider foregut bariatric surgery as an established option to specifically treat NASH. Accordingly, the effects of bariatric surgery on hepatic fibrosis are still unclear. In Egypt there is lack in such type of study thus this research will conducted to evaluate the prevalence of NAFLD and NASH in obese patients undergoing bariatric surgery and to assess the role of bariatric surgery in management of NAFLD related hepatic morbidity in our locality.

Conditions

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NAFLD Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obese Patients With NAFALD Undergoing Bariatric Surgeries

Group Type EXPERIMENTAL

Bariatric Surgery

Intervention Type PROCEDURE

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Interventions

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Bariatric Surgery

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Above 20 years of age
2. morbid obesity
3. severe obesity with as arterial hypertension or type 2 diabetes mellitus (T2DM),

Exclusion Criteria

* 1- chronic liver diseases 2-Long term consumption of hepatotoxic drugs. 3-Active alcohol abuse 4-Medical or psychological contraindications for bariatric Surgery. 5-Refusal of giving a consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Abo Bakr Ahmed Mahmoud

specialist( M. Sc)in Gastroenterology and Infectious Diseases Faculty of Medicine, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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shimaa abo bakr, Msc

Role: CONTACT

01066635612

Ahmed Shawkait

Role: CONTACT

01028030669

References

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Di Palma A, Alhabdan S, Maeda A, Mattu F, Chetty R, Serra S, Quereshy F, Jackson T, Okrainec A. Unexpected histopathological findings after sleeve gastrectomy. Surg Endosc. 2020 May;34(5):2158-2163. doi: 10.1007/s00464-019-07002-7. Epub 2019 Sep 11.

Reference Type BACKGROUND
PMID: 31512035 (View on PubMed)

Papasavas P, Seip RL, Stone A, Staff I, McLaughlin T, Tishler D. Robot-assisted sleeve gastrectomy and Roux-en-y gastric bypass: results from the metabolic and bariatric surgery accreditation and quality improvement program data registry. Surg Obes Relat Dis. 2019 Aug;15(8):1281-1290. doi: 10.1016/j.soard.2019.04.003. Epub 2019 Apr 13.

Reference Type BACKGROUND
PMID: 31477248 (View on PubMed)

Other Identifiers

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Bariatric Surgery in NAFLD

Identifier Type: -

Identifier Source: org_study_id

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