ObesityTaBLFood-MGBNCT04442139
Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Daily Food Choices in Mini-Gastric Bypass
An observational study of Obesity and Morbid Obesity, run by Kular Hospital at 1 site in India.
Trial summary
Bariatric surgery (BS) has a history of new procedures and techniques arising and then disappearing due to problems and complications. The present is no different with new and old procedures changing with the regularity of night following day. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity, Morbid Obesity, Bariatric Surgery Candidate
- What is being tested?
- Mini-Gastric Bypass
- How many people
- 190 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2008to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients completing survey following surgery for Mini-Gastric Bypass performed for morbid obesity
Who may be able to join
- Post Mini-Gastric Bypass Patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Mean Weight Loss and Mean Daily Dietary Food Choices in the One Anastomosis Gastric Bypass (Mini-Gastric Bypass-Original Technique)
Bariatric surgery (BS) has a history of new procedures and techniques arising and then disappearing due to problems and complications. The present is no different with new and old procedures changing with the regularity of night following day.
One of the important questions today in BS is the length and or need/value of the Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have "0" bypass, the RNY has a "short" bypass and the Biliopancreatic Diversion type procedures have a "long" (distal) bypass.
Read more
The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) includes a "medium" length of bypass, longer than the BPLL of the RNY and shorter than the the "Long" BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a "Tailored" BPLL.
Not all OAGB surgeons use this approach and several have argued in favor of a "Fixed" BPLL of 150 cm.
This paper is part of a series of studies of the "Tailored" BPLL specifically in MGB-OT patients.
Notably it demonstrates in an online survey that patient reported weight loss and food choices change after MGB-OT and in addition the changes are related to the "Tailored" BPLL
Read the detailed description
Introduction:
Studies of different Bariatric procedures have resulted in conflicting findings on the effects of the surgery on daily Dietary Food Choices (DFCs.) Some suggest a pure volume effect, others report changes in type and preferences and still others suggest the effects change over time. The Biliopancreatic Limb Length (BPLL) in the One Anastomosis Gastric Bypass (OAGB), Mini-Gastric Bypass-Original Technique (MGB-OT) version, includes a "tailored" BPLL. The purpose of this study was to investigate the relationship between BPLL and DFCs in patients undergoing MGB-OT. The primary hypothesis was that the changes in dietary habits and food choices would be related to the BPLL in the MGB-OT.
Methods:
Data from a long term online patient survey including MGB-OT patients were collected including basic demographics, MGB-OT BPLL, patient reported DFCs and weight loss classes. Linear regression modeling was used to assess the relative association between BPLL with various mean patient reported DFCs and a composite model of Food Choices.
Results:
Patients survey responses to be evaluated. Patients with reported BPLLs of 3 to 9 ft (92-274cm) will be selected. Patient reported mean weight loss classes to be evaluated. The linear relation to BPLL to be evaluated. The mean "Bad" Food Choices (BFC) to be determined.
Conclusions:
The present study of mean patient reported DFC outcomes following a "Tailored" BPLL in the MGB-OT version of the OAGB to be evaluated. The patient dietary food choices for fried foods, sugar sweetened beverages, processed meats and junk foods all to be determined. These changes linear regression to the Bilio-pancreatic limb length to be determined. In cases of the MGB-OT a longer Bilio-pancreatic Limb Length association with greater weight loss and a greater improvement in daily Dietary Food Choices would be major importance. The possibility of tailoring the power of a bariatric operation based upon BPLL might well be an important advancement in bariatric surgery.
- Conditions
- Obesity, Morbid Obesity, Bariatric Surgery Candidate, Food Selection, Diet Habit
- Being tested
- Mini-Gastric Bypass
- Medical subject headings
- Obesity, Obesity, Morbid, Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Gastric BypassOther
Mini-Gastric Bypass bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Mini-Gastric Bypass | Patients reported completing survey following Mini-Gastric Bypass Receives: Other: Mini-Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Choices
Patient Reported Food choices
Measured: from 1 year up to 10 years post operative Mini-Gastric Bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2008
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kular Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert Rutledge, Kular Hospital
- Investigators
- R Rutledge, MD, Principal investigator, Kular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442139
- Sponsor's protocol ID
- TaBLFood-MGB
- Acronym
- TaBLFood-MGB
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes of a "Tailored" Bilio-Pancreatic Limb Length on Mean Weight Loss and Mean Daily Dietary Food Choices in the One Anastomosis Gastric Bypass (Mini-Gastric Bypass-Original Technique)
- ClinicalTrials.gov ID
- NCT04442139
- Acronym / sponsor ID
- TaBLFood-MGB / TaBLFood-MGB
- Conditions
- Obesity, Morbid Obesity, Bariatric Surgery Candidate, Food Selection, Diet Habit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Kular HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bariatric surgery (BS) has a history of new procedures and techniques arising and then disappearing due to problems and complications. The present is no different with new and old procedures changing with the regularity of night following day.
One of the important questions today in BS is the length and or need/value of the Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have "0" bypass, the RNY has a "short" bypass and the Biliopancreatic Diversion type procedures have a "long" (distal) bypass.
The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) includes a "medium" length of bypass, longer than the BPLL of the RNY and shorter than the the "Long" BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a "Tailored" BPLL.
Not all OAGB surgeons use this approach and several have argued in favor of a "Fixed" BPLL of 150 cm.
This paper is part of a series of studies of the "Tailored" BPLL specifically in MGB-OT patients.
Notably it demonstrates in an online survey that patient reported weight loss and food choices change after MGB-OT and in addition the changes are related to the "Tailored" BPLL
Detailed description
Introduction:
Studies of different Bariatric procedures have resulted in conflicting findings on the effects of the surgery on daily Dietary Food Choices (DFCs.) Some suggest a pure volume effect, others report changes in type and preferences and still others suggest the effects change over time. The Biliopancreatic Limb Length (BPLL) in the One Anastomosis Gastric Bypass (OAGB), Mini-Gastric Bypass-Original Technique (MGB-OT) version, includes a "tailored" BPLL. The purpose of this study was to investigate the relationship between BPLL and DFCs in patients undergoing MGB-OT. The primary hypothesis was that the changes in dietary habits and food choices would be related to the BPLL in the MGB-OT.
Methods:
Data from a long term online patient survey including MGB-OT patients were collected including basic demographics, MGB-OT BPLL, patient reported DFCs and weight loss classes. Linear regression modeling was used to assess the relative association between BPLL with various mean patient reported DFCs and a composite model of Food Choices.
Results:
Patients survey responses to be evaluated. Patients with reported BPLLs of 3 to 9 ft (92-274cm) will be selected. Patient reported mean weight loss classes to be evaluated. The linear relation to BPLL to be evaluated. The mean "Bad" Food Choices (BFC) to be determined.
Conclusions:
The present study of mean patient reported DFC outcomes following a "Tailored" BPLL in the MGB-OT version of the OAGB to be evaluated. The patient dietary food choices for fried foods, sugar sweetened beverages, processed meats and junk foods all to be determined. These changes linear regression to the Bilio-pancreatic limb length to be determined. In cases of the MGB-OT a longer Bilio-pancreatic Limb Length association with greater weight loss and a greater improvement in daily Dietary Food Choices would be major importance. The possibility of tailoring the power of a bariatric operation based upon BPLL might well be an important advancement in bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mini-Gastric Bypass | – | Other: Mini-Gastric BypassPatients reported completing survey following Mini-Gastric Bypass |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients completing survey following surgery for Mini-Gastric Bypass performed for morbid obesity
Key inclusion criteria (1 listed)
- Post Mini-Gastric Bypass Patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-Gastric BypassMini-Gastric Bypass bariatric surgery | Other | Mini-Gastric Bypass |
Primary outcome
Food Choices
Time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass
Patient Reported Food choices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Rutledge, MD principal investigator
Kular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbid Obesity, run by Kular Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Choices (time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.