Protocol summary
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Study aim
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Investigation of the effect of bariatric surgery on the presence of biliary reflux in patients with obesity
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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• 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
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Intervention groups
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1- Single anastomosis gastric bypass technique with carbajo technique
2- Traditional single anastomosis gastric bypass group
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Main outcome variables
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Gastroesophageal bile Reflux Disease (GERD)؛ weight loss؛ esophageal mucousal change
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-06-22, 1399/04/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-09-22, 1399/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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the effect of Carbajo's surgical technique on bile reflux
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-10, 1399/02/21
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Ethics committee reference number
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IR.IUMS.REC.1399.211
Health conditions studied
1
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Description of health condition studied
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morbid obesity
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ICD-10 code
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K21
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ICD-10 code description
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Gastro-esophageal reflux disease
Primary outcomes
1
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Description
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GastroEsophageal Reflux Disease
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Timepoint
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12 months after surgery
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Method of measurement
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Cintigraphy after assessment of GERD-Q (gastroesophageal reflux disease questionnaire) equal or more than 8
Intervention groups
1
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Description
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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
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Category
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Treatment - Surgery
2
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Description
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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.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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etics
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Clinical study report
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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No example
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From where data/document is obtainable
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No example
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What processes are involved for a request to access data/document
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No example
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Comments
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