Protocol summary

Summary
The purpose of this study is to compare the severity and prevalence of anxiety disorders, major depression and eating disorders before and after bariatric surgery in morbid obese patients in Rasool-e-Akram hospital in1391. This Study is performed on morbid obese patients with BMI over 40 or BMI over 35 with one obese comorbidity, who will undergo bariatric surgery and the patients with inability to complete the questionnaire for any reasons are excluded. The morbid obese patients who are candidates for bariatric surgery in obesity clinic of Rasool-e-Akram hospital in 1391 are studied and the sample size is 68. In cases by using the Hamilton test assays depression and anxiety disorder, with SCID-1 test assays major depression and anxiety, eating disorders is checked by using the Eating Disorder Inventory and SF36-V2 checks the quality of life. The patients will undergo bariatric surgery for a uniform method and after six months these factors will be checked by using above tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206288588N8
Registration date: 2012-09-28, 1391/07/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-28, 1391/07/07
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Severity and prevalence of anxiety disorders, major depression and eating disorders before and after bariatric surgery in morbid obese patients
Public title
The effect of bariatric surgery on anxiety disorder,depression and eating disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Obese patients with BMI over 40 or over 35 with one obese comorbidity who are undergoing obesity surgery. Exclusion criteria: the patients with inability to complete the questionnaire for any reasons.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences.
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
54765

Health conditions studied

1

Description of health condition studied
Panic disorder [episodic paroxysmal anxiety], Obsessive-compulsive disorder, Agoraphobia
ICD-10 code
F41,F42,F4
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety], Obsessive-compulsive disorder ,Agoraphobia

2

Description of health condition studied
severe depressive episode without psychotic symptoms
ICD-10 code
F32.2
ICD-10 code description
severe depressive episode without psychotic symptoms

3

Description of health condition studied
Eating disorders
ICD-10 code
F50
ICD-10 code description
Eating disorders

Primary outcomes

1

Description
Hamilton anxiety score, Hamilton depression score.
Timepoint
Befor Intervention, 6 Month after intervention.
Method of measurement
Hamilton Anxiety and Depression Questionnaire, Quality of Life Questionnaire

Secondary outcomes

1

Description
Aggression
Timepoint
Befor intervention, 6 month after intervention
Method of measurement
Question

Intervention groups

1

Description
Laparoscopic bariatric Surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e-Akram Hospital
Full name of responsible person
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical sciences.
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Dr.Diana Matini
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Tehran Psychiatric Institute, Mansouri Ave., Niyayesh Ave., Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+216 4351
Fax
Email
Diana.matini@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Dr.Atefeh Ghanbari
Position
Psychiatrist
Other areas of specialty/work
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
draghj@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Minimally Invasive Surgery Reseach Center
Full name of responsible person
Mohadeseh Pishgahroudsari
Position
Expert Stata
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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