Efficacy of SASI Bypass in Super Obese Patients

NCT ID: NCT04037670

Last Updated: 2019-07-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

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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SASI bypass

Patients with super obesity underwent SASI bypass

Group Type EXPERIMENTAL

SASI bypass

Intervention Type PROCEDURE

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

Interventions

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SASI bypass

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura101

Identifier Type: -

Identifier Source: org_study_id

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