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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03796325
Other study ID # AMC 002-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date December 22, 2018

Study information

Verified date December 2018
Source Assuta Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Obesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression


Description:

The patients were classified as suffering from a depressive state before the bariatric surgery and followed until 3 years after surgery, the data was collected by personal interview or telephone survey.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 22, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 18 years and older No any type of complication after surgery No difficult to drink, eat or take medicaments

Exclusion Criteria:

Any surgical complication Previous gastrointestinal surgery schizofrenia

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Assuta MC Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Griauzde DH, Ibrahim AM, Fisher N, Stricklen A, Ross R, Ghaferi AA. Understanding the psychosocial impact of weight loss following bariatric surgery: a qualitative study. BMC Obes. 2018 Dec 3;5:38. doi: 10.1186/s40608-018-0215-3. eCollection 2018. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss 3 years after laparoscopic sleeve gastrectomy Measure of weight calculating Delta body mass index between preoperative measurement and three years after surgery 36 month
Secondary Depression state changes after Sleeve gastrectomy Telephonic Questionnaire about feeling satisfaction (Very satisfied, satisfied, indifferent ,unsatisfied), eating mode (Volume-eater, sweet-eater, snack eater, binge eater, healthy-eater), occupations (Unemployed, employed, type of employment). 36 month
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