Comparing the effect of Laparoscopic One Anastomosis Gastric Bypass and Carbajo’s gastric bypass on incidence of bile reflux in morbid obese patients: a randomized controlled clinical trial
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Primary outcomes
#1
HIDAscan (cholescintigraphy)
Cintigraphy after assessment of GERD-Q (gastroesophageal reflux disease questionnaire) equal or more than 8
HIDAscanCintigraphy after assessment of GERD-Q (cholescintigraphygastroesophageal reflux disease questionnaire) equal or more than 8
سینتی گرافی
سینتی گرافی پس از بررسی نمره GERD-Q (پرسشنامه ریفلاکس معده به مری) بالاتر مساوی 8
سینتی گرافی پس از بررسی نمره GERD-Q (پرسشنامه ریفلاکس معده به مری) بالاتر مساوی 8
Recruitment centers
#1
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic
Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم
Full name of responsible person - English: mohamad kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Street address - English: sattarkhan street
Street address - Persian: خیابان ستارخان
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic
Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Street address - English: Sattarkhan street
Street address - Persian: خیابان ستارخان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم Full name of responsible person - English: mohamad kermansaraviMohammad Kermansaravi Full name of responsible person - Persian: محمد کرمان ساروی Street address - English: sattarkhanSattarkhan street Street address - Persian: خیابان ستارخان City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۵۶۱۳۱۳۱ Phone: +98 21 6655 5447 Fax: Email: mkermansaravi@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: abdolreza pazouki
Full name of responsible person - Persian: عبدالرضا پازوکی
Street address - English: sattarkhan
Street address - Persian: خیابان ستارخان، مرکز تحقیقات جراحی کم تهاجمی
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abdolreza Pazouki
Full name of responsible person - Persian: عبدالرضا پازوکی
Street address - English: Sattarkhan
Street address - Persian: خیابان ستارخان، مرکز تحقیقات جراحی کم تهاجمی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: abdolreza pazoukiAbdolreza Pazouki Full name of responsible person - Persian: عبدالرضا پازوکی Street address - English: sattarkhanSattarkhan Street address - Persian: خیابان ستارخان، مرکز تحقیقات جراحی کم تهاجمی City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۵۶۱۳۱۳۱ Phone: +98 21 6655 5447 Fax: Email: mkermansaravi@yahoo.com Web page address:
Protocol summary
Study aim
Investigation of the effect of bariatric surgery on the presence of biliary reflux in patients with obesity
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 100 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
People with obesity who go to the obesity clinic of Rasoul Akram Hospital will be examined after being examined by the obesity clinic team and BMI calculation and if they have the conditions.
They are then placed in control and carbajo groups.
The study participants were examined using radioactive materials according to the HIDAscan procedure 12 months after surgery. If the syntax is positive, the patient will undergo endoscopy and pH. If the patient complains of reflux symptoms or the GERDQ questionnaire is positive but the chest x-ray is negative, then the patient will be treated with oral pentoprazole at a dose of 40 mg every 12 hours for 6 weeks and if not resolved. Symptoms will be directed to the patient for endoscopy and pH.
Patients are divided into two groups using four randomized blocks.
Participants/Inclusion and exclusion criteria
• BMI≥40
• BMI ≥35> 40 with at least one complication associated with obesity with failure of conventional non-surgical treatments
• BMI ≥ 30 with diabetes with recent onset
• Acceptable surgical risk
• Complete and sign the consent form for participation in the study and commit to return for further follow-up
• Treatment with OAGB or Carbacho surgery
Intervention groups
1- Single anastomosis gastric bypass technique with carbajo technique
2- Traditional single anastomosis gastric bypass group
Main outcome variables
Gastroesophageal bile Reflux Disease (GERD)؛ weight loss؛ esophageal mucousal change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042520N2
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2022-06-26, 1401/04/05
Update count:1
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Mohammad Kermansaravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 5451
Email address
kermansaravi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Laparoscopic One Anastomosis Gastric Bypass and Carbajo’s gastric bypass on incidence of bile reflux in morbid obese patients: a randomized controlled clinical trial
Public title
the effect of Carbajo's surgical technique on bile reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI≥40
BMI ≥35> 40 with at least one obesity-related complication with failure of conventional non-surgical treatments
BMI ≥30 with diabetes with recent onset
Acceptable surgical risk
Complete and sign the informed consent of the company to participate in the study and commit to return for further follow-up
OAGB or Carbajo surgery
Exclusion criteria:
Obesity due to treatable endocrine diseases such as Cushing's
• High risk of anesthesia after heart and lung counseling
• Diagnosing the surgeon based on the high risk of surgery
• Drug addiction
• Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist
Pregnancy or pregnancy planning for the next two years in married women of childbearing age
Severe preoperative reflux: GERD Score greater than or equal to eight according to the GERD Q questionnaire
Severe to moderate severe or severe herniated epilepsy according to endoscopy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using four randomized blocks. One of the statistical specialists who is not present in the project is responsible for randomly assigning individuals to the two groups after examining the achievement of admission criteria. (One of the two methods mentioned above), he is contacted and he tells us the type of surgery that is going to be performed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of his surgical procedure, but we will explain to him about these two methods, and the purpose of this study will be explained to him. They are explained and after obtaining informed consent, they enter the study. In this study, the doctor who performs the surgery is definitely aware of the surgical procedure. To minimize the surgeon's awareness error, the doctor who evaluates the reflux is different from the surgeon, but despite this, the study is considered single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.IUMS.REC.1399.211
Health conditions studied
1
Description of health condition studied
morbid obesity
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
GastroEsophageal Reflux Disease
Timepoint
12 months after surgery
Method of measurement
Cintigraphy after assessment of GERD-Q (gastroesophageal reflux disease questionnaire) equal or more than 8
Secondary outcomes
empty
Intervention groups
1
Description
1- Typical one-anastomosis bypass method: In the distal area, we enter the crow's foot to crow's foot, and on the 36 F bougie, using a few 60 mm endo staplers with a suitable staple height, the stomach pouch is made long and narrow. In the next step, gastrojejunal anastomosis is performed with 45 mm blue stapler and the intestinal site is sutured with 2-0 PDS sutures from 150 to 200 cm depending on BMI, age, height and comorbidities
Category
Treatment - Surgery
2
Description
2. Single anastomosis bypass with Carbajo technique: In Carbajo method, the steps are the same as traditional method and only a few differences are seen: 1- The length of the pouch is 13 to 15 cm. 2. Gastrojejunal anastomosis is 2 to 2.5 cm. 3. The length of the biliopancreatic limb is 250 to 350 cm on average. 4. The proximal portion of the gastrojejunal anastomosis is 8 to 10 cm long and sewn to the pouch and then to the remnant in the opposite direction of gravity.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital Obesity Clinic
Full name of responsible person
Mohammad Kermansaravi
Street address
Sattarkhan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6655 5447
Email
mkermansaravi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Pazouki
Street address
Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6655 5447
Email
mkermansaravi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kermansaravi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No 17 ،Morvarid 3،Sadaf Ave،Dadman Blvd،Qods Town
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8809 5451
Fax
Email
kermansaravi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kermansaravi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No 17 ،Morvarid 3،Sadaf Ave،Dadman Blvd،Qods Town
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8809 5451
Fax
Email
kermansaravi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Kermansaravi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No 17 ،Morvarid 3،Sadaf Ave،Dadman Blvd،Qods Town
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8809 5451
Fax
Email
kermansaravi.m@iums.ac.ir
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
etics
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No example
From where data/document is obtainable
No example
What processes are involved for a request to access data/document