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the effect of Carbajo's surgical technique on bile reflux

Phase 3
Completed
Conditions
morbid obesity.
Gastro-esophageal reflux disease
Registration Number
IRCT20190128042520N2
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
74
Inclusion Criteria

BMI=40
BMI =35> 40 with at least one obesity-related complication with failure of conventional non-surgical treatments
BMI =30 with diabetes with recent onset
Acceptable surgical risk
Complete and sign the informed consent of the company to participate in the study and commit to return for further follow-up
OAGB or Carbajo surgery

Exclusion Criteria

Obesity due to treatable endocrine diseases such as Cushing's
• High risk of anesthesia after heart and lung counseling
• Diagnosing the surgeon based on the high risk of surgery
• Drug addiction
• Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist
Pregnancy or pregnancy planning for the next two years in married women of childbearing age
Severe preoperative reflux: GERD Score greater than or equal to eight according to the GERD Q questionnaire
Severe to moderate severe or severe herniated epilepsy according to endoscopy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
GastroEsophageal Reflux Disease. Timepoint: 12 months after surgery. Method of measurement: Cintigraphy after assessment of GERD-Q (gastroesophageal reflux disease questionnaire) equal or more than 8.
Secondary Outcome Measures
NameTimeMethod
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