The present study has been undertaken with an aim to study the outcomes of a new modification of jejuno-ileal bypass (JIB) bariatric surgery. This clinical trial was carried out on 200 obese patients who underwent modified jejuno-ileal bypass surgery. Obese patients of both sexes with BMI more than 40 or those having 100 lb more than ideal weight, referring for bariatric surgery to Imam Reza & Shahryar hospitals- Tehran from 2005-2011 were included in this study. Patients aged more than 55 and less than 15 years, patients suffering from certain diseases like diabetes were excluded from the study.
For this purpose, after exploring the abdoment in the operation room, jejunum was cut at about 20 cm of treitz ligament and its proximal end was anastomosed to terminal ileum at 30–35 centimeter away from ileocecal valve (end to side) and distal end was anastomosed to the Gall blader (side to side ).
General information
Acronym
Bariatric Surgery
IRCT registration information
IRCT registration number:IRCT2014020216322N2
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Nahid Arian pour
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8350
Email address
s.dehkhoda@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA university of medical sciences
Expected recruitment start date
2005-01-01, 1383/10/12
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To study the outcomes of a new modification of jejuno-ileal bypass bariatric surgery.
Public title
To study the outcomes of a new modification of jejuno-ileal bypass bariatric surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion / Exclusion :
Inclusion criteria- Obese patients of both sexes with BMI more than 40 or those having 100 lb more than ideal weight referring for bariatric surgery to Imam Reza & Shahryar hospitals- Tehran from 2005-2011 were included in this study.
Exclusion criteria- Patients aged more than 55 and less than 15 years؛ patients suffering from hypothyroidism and insulin-dependent diabetes؛ those with previous gastro-intestinal surgery excepting appendectomy or presence of any pathological disorder in digestive system؛ treatment with corticoids and antibiotics؛ alcohol addicts and psychotic patients were excluded from the study.
Age
From 16 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of AJA university of medical sciences
Street address
Etemadzadeh ave. West Fatemi-Tehran- Iran
City
Tehran
Postal code
Approval date
2014-02-09, 1392/11/20
Ethics committee reference number
9217
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
Z40-Z45
ICD-10 code description
Factors influencing health status and contact with health
Primary outcomes
1
Description
Weight loss
Timepoint
After 1 month- first 6month- 2nd 6 month- after 2 years
Method of measurement
measuring weight by balance
Secondary outcomes
1
Description
Effect of drain on surgical site infection rate
Timepoint
upto one week
Method of measurement
Any sign of infection
Intervention groups
1
Description
Bariatric surgery is performed in such a way that a part of small intestine is diverted in order to cause malabsorption.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital affiliated to AJA university of medical sciences & Shahryar hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Lashkari
Street address
Etemadzadeh ave., West Fatemi, Tehran, Iran
City
Tehran
Grant name
تحقیقات
Grant code / Reference number
84/90/306
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA 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
AJA University of Medical Sciences
Full name of responsible person
Dr Nahid Arian pour
Position
faculty member-PhD
Other areas of specialty/work
Street address
Etemadzadeh ave., West Fatemi, Tehran, Iran
City
Tehran
Postal code
1411718541
Phone
+98 912 207 7306
Fax
+98 21 8833 7943
Email
Med.arian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza hospital-
Full name of responsible person
Dr Salman Dehkhoda
Position
faculty member- MD surgery
Other areas of specialty/work
Street address
Imam Reza hospital- Etemadzadeh ave., West Fatemi, Tehran-Iran
City
Tehran
Postal code
1411718541
Phone
+98 912 158 1175
Fax
+98 21 8833 7943
Email
Dehkhodas@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Dr Nahid Arian pour
Position
Faculty member- PhD
Other areas of specialty/work
Street address
Etemadzadeh ave., West Fatemi, Tehran, Iran
City
Tehran
Postal code
1411718541
Phone
+98 912 297 7306
Fax
+98 21 8833 7943
Email
Med.arian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)