Comparison of the effect of two 3.5 x 45 and 3.5 x 45 mm jejunal bypasses on the weight of obese patients
Design
Fifty patients undergoing gastric bypass surgery were randomly assigned into two groups of 25 each. In the first group, the jejunum is cut at 30 x 3.5 mm in the first group and 40 x 3.5 x 2 mm in the second group. All patients were followed up at one month, three months and 6 months after surgery and weight loss rates were compared between the two groups.
Settings and conduct
In this single-blind clinical trial will be done in Alzahra Hospital of Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI between 40 and 50, age of over 40 years old, consent to participate in the study. Exclusion criteria: Hypothyroidism, diabetes
Intervention groups
Intervention group 1: 3.5 x 30 mm incision in gastric jejunostomy. Intervention group 2: 45 x 3.5 mm diameter incision in gastric jejunostomy
Main outcome variables
Weight changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N45
Registration date:2020-03-20, 1399/01/01
Registration timing:prospective
Last update:2020-03-20, 1399/01/01
Update count:0
Registration date
2020-03-20, 1399/01/01
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of two 3.5 x 30 and 45 * 3.5 mm jejunum incisions during gastric bypass gastrectomy on weight of obese patients
Public title
The effect of gastric resection on the weight of obese patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age lower 40 years
Range of Body Mass Index between 40-50
agree to participate in the study
Exclusion criteria:
Performing previous abdominal surgery
Hypothyroidism
Diabetes
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized sari is performed between the two groups using random allocation software. So that the sample size is first entered into the software and then the number of groups is determined. The software output is a list that distributes 80 samples randomly into groups. Patients are divided into two groups according to the time of referral in order to reach the required sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be done in a single blind and patients are unaware about the length of the narrow intestine that is removed during surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Soffeh Street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.MUI.MED.REC.1398.333
Health conditions studied
1
Description of health condition studied
Excessive Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Weight changes
Timepoint
1, 3 and 6 months after surgery
Method of measurement
By using Body Mass Index, calculated by square of height(m) divided to wieght (kg)
Secondary outcomes
1
Description
Changes of serum level of Albumin
Timepoint
1,3 and 6 months after operation
Method of measurement
Blood sample and laboratory test
Intervention groups
1
Description
Intervention group 1: Cut jejunum at 3.5 x 30 mm in gastric bypass. Intervention group 2: jejunal incision at 3.5 x 45 mm in gastric bypass.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital of Isfahan
Full name of responsible person
Mohamad Harandizadeh
Street address
Soffeh Street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
dr_harandizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behrouz Keleidari
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
keleidari@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Mahmoudieh
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Soffeh Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
mahmoudieh@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8081
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data belongs to a governmental agency
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Due to the fact that the information belongs to the governmental organization, it is not possible to share it.
When the data will become available and for how long
Any time
To whom data/document is available
Every person
Under which criteria data/document could be used
any status
From where data/document is obtainable
Any person
What processes are involved for a request to access data/document