Depressive State After Sleeve Gastrectomy

Depression Clinical Trial

Official title:

Effect of Laparoscopic Sleeve Gastrectomy in Obese Patients With Depressive State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796325
• Other study ID #: AMC 002-2018
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Obesity, Morbid

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