Comparing the results of gastric bypass anastomosis with 150 and 180 cm biliopancreas in patients with class 3 obesity
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 80 patients. Blocks of four will be used for randomization.
Settings and conduct
This study is a randomized clinical trial (blocks of four), double blind (participants and results analyzer), with parallel groups, without a control group and with the participation of 80 patients with gastric bypass surgery referred to Imam Reza Hospital (Tabriz).Patients will be randomly divided into two groups. 150 cm biliopancreas surgery method will be used for one group and 180 cm biliopancreas surgery method will be used for the other group. Finally, metabolic indices and response to surgery will be measured.
Participants/Inclusion and exclusion criteria
The most important criteria for entering the study include: class III obesity (body mass index above 40), candidate for gastric bypass surgery, surgery performed by a single surgeon and consent to participate in the study, and the most important exclusion criteria include: previous surgery on On the stomach, there will be patients with gastrointestinal cancers, patients with metabolic problems, and patients receiving any type of multivitamin for systemic problems.
Intervention groups
In this study, patients who undergo gastric bypass surgery and an anastomosis with biliopancreas of 150 and 180 cm will be included in the study. Patients will be randomly divided into two groups. 150 cm biliopancreas surgery method will be used for one group and 180 cm biliopancreas surgery method will be used for the other group. Finally, metabolic indices and response to surgery will be measured.
Main outcome variables
Body mass index changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N39
Registration date:2023-12-09, 1402/09/18
Registration timing:prospective
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-19, 1402/10/29
Expected recruitment end date
2025-01-18, 1403/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of single-anastomosis gastric bypass with 150 and 180 cm biliopancreas in patients with class 3 obesity
Public title
Comparison of results of single-anastomosis gastric bypass with biliopancreas in patients with class 3 obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class III obesity (body mass index above 40)
Candidate for gastric bypass surgery
Surgery performed by a single surgeon
Consent to participate in the study
Exclusion criteria:
Previous surgery on the stomach
Patients with gastrointestinal cancers
Patients with metabolic problems
Patients receiving any type of multivitamin due to systemic problems
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method in order to balance the number of allocated samples, and with 4 people in each block, the whole block We put the possible ones as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose from numbers one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will be divided into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of equipment used, in this study they will not know what type of equipment will be used in other patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.TBZMED.REC.1402.523
Health conditions studied
1
Description of health condition studied
Body mass index changes
ICD-10 code
Z68.35
ICD-10 code description
Body mass index (BMI) 35.0-35.9, adult
Primary outcomes
1
Description
Body mass index changes
Timepoint
Once every three months for one year after surgery
Method of measurement
Weight measuring scale and meter for measuring height
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 150 cm, and then the body mass index will be measured for one year after the surgery and once every three months.
Category
Treatment - Surgery
2
Description
Control group: In patients of this group, gastric bypass will be performed laparoscopically with an anastomosis size of 180 cm, and then the body mass index will be measured for one year after the surgery and once every three months.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Abdolreza Mehdinavaz Aghdam
Street address
Imam Reza pital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available