This study is a single blind, randomized clinical trial. The purpose of this study is comparison between complications of two methods of surgery (Gastric Bypass and Banding) in the treatment of morbid obesity in patients who are candidates for surgical treatment in Imam Reza Hospital of Kermanshah.
The criteria for inclusion of study are: BMI between 30 to 50; The absence of hiatal hernia; No history of previous surgery. The criteria for exclusion of study are: Immunodeficient patients; Who had a history of steroid use; Patients with a history of mental illness. A total of 290 patients are randomly allocated into two groups surgery (Gastric Bypass and Banding). Both groups will be followed and compared during six month period of time, for complications (Bleeding, Wound Infection, and Hematoma).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013013112322N1
Registration date:2013-09-19, 1392/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-19, 1392/06/28
Registrant information
Name
Baharak Shahin
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6303
Email address
shahin.baharak@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and Technology
Expected recruitment start date
2013-10-15, 1392/07/23
Expected recruitment end date
2014-03-15, 1392/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of surgical complications and outcomes of gastric bypass and banding in morbid obesity
Public title
Comparative study of surgical complications and outcomes of gastric bypass and banding in morbid obesity
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for inclusion of study are: BMI between 30 to 50; The absence of hiatal hernia; No history of previous surgery. The criteria for exclusion of study are: Immunodeficient patients; Who had a history of steroid use; Patients with a history of mental illness.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
290
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences. Research Center
Street address
University Research Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
6154896587
Approval date
2011-11-26, 1390/09/05
Ethics committee reference number
38630
Health conditions studied
1
Description of health condition studied
Morbid Obesity
ICD-10 code
E66.01
ICD-10 code description
Morbid (severe) obesity due to excess calories
Primary outcomes
1
Description
Bleeding
Timepoint
At the first week, third and sixth months
Method of measurement
Corresponding to physical examination
Secondary outcomes
1
Description
Hematoma
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
2
Description
Wound Infection
Timepoint
At the first week, third and sixth months
Method of measurement
corresponding to physical examination
Intervention groups
1
Description
Gastric Bypass
(In this procedure first divides the stomach into a small upper pouch and a much larger lower "remnant" pouch and then re-arranges the small intestine to connect to both)
Category
Treatment - Surgery
2
Description
Banding
(This is a medical procedure which uses elastic bands for constriction)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah
Full name of responsible person
Baharak Shahin
Street address
General Surgery Ward, Imam Reza Hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
University Research Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah university of medical sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Baharak Shahin
Position
Resident of General Surgery
Other areas of specialty/work
Street address
University Research Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158878888
Phone
+98 83 1838 4185
Fax
+98 83 1427 6310
Email
Shahin.baharak@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Khosro Setayeshi
Position
General Surgeon
Other areas of specialty/work
Street address
University Research Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158965478
Phone
+98 83 1838 4185
Fax
+98 83 1839 4920
Email
k.setaishi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Baharak Shahin
Position
Resident of General Surgery
Other areas of specialty/work
Street address
University Research Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6158878888
Phone
+98 83 1838 4185
Fax
+98 83 1427 6310
Email
Shahin.baharak@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)