1. Objectives: In this study, we are intending to compare safety and efficacy of LGP and LMGB for the treatment of morbid obesity.
2. Setting and conduct: This study conducts at Sina hospital.
3. Design and Intervention: Forty morbid obese patients meet the National Institutes of Health (NIH) criteria, and randomly assign to receive either Laparoscopic Gastric Plication (N=20) or Laparoscopic Mini-Gastric Bypass (N=20).
4. Participants eligibility criteria:
Inclusion criteria: morbid obesity ( BMI>40 kg/m2 or BMI>35kg/m2 with co-existing morbidities); age 18 to 65; previous unsuccessful weight loss attempts
Exclusion criteria: previous restrictive or malabsorptive procedure for obesity treatment; previous gastric surgery; history of anti-reflux surgery; pregnancy
5. Main outcome measured variables: early and late complications, body mass index (BMI), excess weight loss (EWL) and obesity related co-morbidities determine at one year follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712294N1
Registration date:2013-02-13, 1391/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Reza Heydari
Name of organization / entity
School of Medicine, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7780 7967
Email address
heydari@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-31, 1389/01/11
Expected recruitment end date
2011-04-30, 1390/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The safety and efficacy of Laparoscopic Gastric Plication versus Laparoscopic Mini-Gastric Bypass surgery in the treatment of morbid obesity
Public title
Laparoscopic Gastric Plication versus Laparoscopic Mini-Gastric Bypass surgery
in the treatment of morbid obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: morbid obesity ( BMI>40 kg/m2 or BMI>35kg/m2 with co-existing
morbidities ); age 18 to 65; previous unsuccessful weight loss attempts
Exclusion criteria: previous restrictive or malabsorptive procedure for obesity treatment; previous gastric surgery; history of anti-reflux surgery; pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences.
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
1417613151
Approval date
2011-10-20, 1390/07/28
Ethics committee reference number
901301315
Health conditions studied
1
Description of health condition studied
Morbid obesity
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity
Primary outcomes
1
Description
Operative time
Timepoint
during surgery
Method of measurement
with a clock
2
Description
length of hospitalization
Timepoint
after discharging
Method of measurement
days of hospitalization
3
Description
percent of excess weight loss
Timepoint
12 months follow-up
Method of measurement
weight
4
Description
hypertension
Timepoint
12 months follow-up
Method of measurement
clinical examination and non invasive blood pressure measurement
5
Description
Diabetes
Timepoint
12-month follow-up
Method of measurement
FBS , HgA1c
6
Description
hyperlipidemia
Timepoint
12 months follow-up
Method of measurement
cholesterol level,triglyceride
7
Description
Gastroesophageal reflux disease
Timepoint
12 months follow-up
Method of measurement
Asking the patient
8
Description
menstrual cycle
Timepoint
12 months follow-up
Method of measurement
asking the patient
9
Description
Degenerative joint disease
Timepoint
12 months follow-up
Method of measurement
history taking and physical exams
10
Description
Sleep apnea
Timepoint
12 months follow-up
Method of measurement
Asking the patient
11
Description
Depression
Timepoint
12 months follow-up
Method of measurement
Beck Depression Inventory score
12
Description
back pain
Timepoint
12 months follow-up
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Laparoscopic Gastric Plication
Category
Treatment - Surgery
2
Description
Laparoscopic Mini-Gastric Bypass
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital.
Full name of responsible person
Mohammad Talebpour
Street address
Laparoscopic Ward, Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, 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
Vice chancellor for research, 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
Laparoscopic ward, Sina Hospital, Hasanabad Sq., Imam Khomeini St.
Full name of responsible person
Mohammad Talebpour
Position
Head of Laparoscopic Ward/Associate Professor
Other areas of specialty/work
Street address
Laparoscopic Ward, Sina Hospital, Tehran University of medical sciences
City
Tehran
Postal code
1136746911
Phone
+98 21 7780 7967
Fax
Email
mtaleb7155@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laparoscopic Ward, Sina Hospital, Tehran University of Medical Science (TUMS),Tehran, Iran.
Full name of responsible person
Reza Heidari
Position
Head of Laparoscopic Ward/Associate Professor
Other areas of specialty/work
Street address
Laparoscopic ward, Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 7780 7967
Fax
Email
mtaleb7155@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of medicine, Tehran university of medical sciences
Full name of responsible person
Reza Heydari
Position
Other areas of specialty/work
Street address
Laparoscopic ward, Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
00
Fax
Email
heidari.reza1@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)