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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03821688
Other study ID # fac.med.047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2019
Est. completion date August 10, 2020

Study information

Verified date December 2021
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.


Description:

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date August 10, 2020
Est. primary completion date August 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
SAS-JB
single anastomosis sleeve jejunal bypass
OAGB
one anastomosis gastric bypass
LSG
laproscopic sleeve gastrectomy

Locations

Country Name City State
Egypt Faculty of medicine Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of excess weight loss percentage of excess weight loss in kilogram 12 months
Secondary the incidence of nutritional deficiency the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia. 2 years
Secondary the rate of improved co morbidity the effect of the operation on co morbidity like diabetes and hypertension 2 years
Secondary the incidence of early operative complications early operative complications like leak, bleeding one month
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