Obesity, MorbidBplVsWtLossNCT04440306
"Tailored" Bilio-Pancreatic Limb Length and Weight Loss After Mini-Gastric Bypass
An observational study of Obesity, Morbid and Weight Loss, run by Kular Hospital at 1 site in India.
Trial summary
Retrospective review of prospectively collected blinded patient data. To Address simple question: In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10 years following operation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Morbid, Weight Loss, Bariatric Surgery Candidate
- What is being tested?
- Mini-Gastric Bypass - Original Technique
- Type of treatment
- Surgery or procedure
- How many people
- 191 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2018to 1 Feb 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 70 years
- All sexes
- Adult, Older adult
Study population: Patients selected for Mini-Gastric Bypass - Original Technique at Kular Hospital
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Tailored" Bilio-Pancreatic Limb Length and Weight Loss After One Anastomosis Gastric Bypass [" Mini-Gastric Bypass Original Technique"]
Retrospective review of prospectively collected blinded patient data. To Address simple question:
In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10 years following operation.
Read the detailed description
Methods:
The investigators performed a review of a prospectively collected database system of patients undergoing tailored MGB-OT at Kular hospital, Punjab, India. Patients who underwent tailored MGB-OT between June 2008 and December 2009 were included. Primary outcomes of interest included a variety of weight loss outcome measures including % Excess Weight Loss (%EWL) at 1, 5 and 10 years in relation to a "tailored" Bilio-Pancreatic Limb Length (BPLL.)
The study was motivated by questions raised suggesting that a BPLL in the OAGB (MGB-OT) should be limited to 150 cm. Data were collected with a team of nurses and support staff that maintained a daily calling and follow up list adding data to an easily accessible online electronic database.
The analytic process assessed various weight loss outcomes at 1, 5 and 10 years following "tailored" BPLLs in patients undergoing the Mini-Gastric Bypass Original Technique (MGB-OT) as described by Rutledge. In addition to using simple statistical methods to assess the relation of the BPLLs to weight loss outcomes, a linear regression model was used to analyse and quantify the relationship between the length of the tailored BP limb and the weight loss measures a 1, 5 and 10 years after operation.
The study design focused upon the "power" of the BPLL as measured by 1, 5 and 10 year weight loss outcomes. The study was designed to answer two specific questions: first is a "FIXED" BPLL of 150 cm best for everyone (I.e. like the fixed BPLL used in the RNY) or put differently: is a 150 cm BPLL equally efficacious as compared to a longer BPLL when judged by measures of weight loss at 1, 5 and 10 years after surgery. Analysis included comparing BPLLs to the various 1, 5 and 10 year weight loss measures such as BMI, %BMI lost, Total weight at 10 years, % Excess Weight Loss at 10 yrs and other standard outcome measures.
Further, if such a relationship does indeed exist, can it be more precisely quantified? For example, is it "linear," that is to say for each and every additional cm of BPLL do the various long term weight loss measures increase similarly?.
There are of course many other questions now in bariatric surgery and related to the MGB/OAGB but the present study was designed to be sharply focused upon these two questions. Risk benefit and predictive power and multivariate analysis and creation of guidelines are in process and have been addressed in the past and will be part of subsequent publications., , ,
Notably the government of India health-care system provides no support for bariatric surgery and specifically no support at all for the MGB at any time during the course of this study and up until the time of this writing. All patients in the study paid out of pocket for the operation. The self pay situation and the fact that poor outcomes are little tolerated are also worthwhile noting. Given this climate and the capped hospital resources in a small town, it has been remarkable that the surgeons in this study have maintained a sterling record of excellent outcomes, a busy clinical practice with outcomes and results that rival those reported from other areas of the world including some of the best hospitals in the United States. The "tailored" MGB-OT used by the surgeon authors facilitated excellent outcomes and supported their success even in such demanding circumstances.
Once a significant association between BPLL and outcomes was determined, then a linear regression analysis was performed to further quantitate and describe the relationship between BPLL and outcome measures.
The present small first step is part of a longer term effort to investigate creation of a tool so robust that it might act as a guide for both patients and surgeons who might select the MGB-OT.
The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical permission was obtained from the local ethics committee and all participants provided written informed consent for data sharing.
- Conditions
- Obesity, Morbid, Weight Loss, Bariatric Surgery Candidate, Power
- Being tested
- Mini-Gastric Bypass - Original Technique
- Keywords
- Mini-Gastric Bypass, Bilio-Pancreatic Limb Length, Weight loss, One Anastomosis Gastric Bypass
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Gastric Bypass - Original TechniqueProcedure or surgery
Also called Tailored Bilio-Pancreatic Limb Length
Mini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Excess Weight Loss
Amount of weight lost assessed by Percent Excess Weight Loss
Measured: 10 years following operation
Percent Total Weight Loss
Amount of weight lost assessed by Percent of Total Weight Loss
Measured: 10 years following operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- 191 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
- NCT04440306
- Sponsor's protocol ID
- BPLL-vs-WtLoss
- Acronym
- BplVsWtLoss
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 19 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Tailored" Bilio-Pancreatic Limb Length and Weight Loss After One Anastomosis Gastric Bypass [" Mini-Gastric Bypass Original Technique"]
- ClinicalTrials.gov ID
- NCT04440306
- Acronym / sponsor ID
- BplVsWtLoss / BPLL-vs-WtLoss
- Conditions
- Obesity, Morbid, Weight Loss, Bariatric Surgery Candidate, Power
- Keywords
- Mini-Gastric Bypass, Bilio-Pancreatic Limb Length, Weight loss, One Anastomosis Gastric Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Kular HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 19 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.
Retrospective review of prospectively collected blinded patient data. To Address simple question:
In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10 years following operation.
Detailed description
Methods:
The investigators performed a review of a prospectively collected database system of patients undergoing tailored MGB-OT at Kular hospital, Punjab, India. Patients who underwent tailored MGB-OT between June 2008 and December 2009 were included. Primary outcomes of interest included a variety of weight loss outcome measures including % Excess Weight Loss (%EWL) at 1, 5 and 10 years in relation to a "tailored" Bilio-Pancreatic Limb Length (BPLL.)
The study was motivated by questions raised suggesting that a BPLL in the OAGB (MGB-OT) should be limited to 150 cm. Data were collected with a team of nurses and support staff that maintained a daily calling and follow up list adding data to an easily accessible online electronic database.
The analytic process assessed various weight loss outcomes at 1, 5 and 10 years following "tailored" BPLLs in patients undergoing the Mini-Gastric Bypass Original Technique (MGB-OT) as described by Rutledge. In addition to using simple statistical methods to assess the relation of the BPLLs to weight loss outcomes, a linear regression model was used to analyse and quantify the relationship between the length of the tailored BP limb and the weight loss measures a 1, 5 and 10 years after operation.
The study design focused upon the "power" of the BPLL as measured by 1, 5 and 10 year weight loss outcomes. The study was designed to answer two specific questions: first is a "FIXED" BPLL of 150 cm best for everyone (I.e. like the fixed BPLL used in the RNY) or put differently: is a 150 cm BPLL equally efficacious as compared to a longer BPLL when judged by measures of weight loss at 1, 5 and 10 years after surgery. Analysis included comparing BPLLs to the various 1, 5 and 10 year weight loss measures such as BMI, %BMI lost, Total weight at 10 years, % Excess Weight Loss at 10 yrs and other standard outcome measures.
Further, if such a relationship does indeed exist, can it be more precisely quantified? For example, is it "linear," that is to say for each and every additional cm of BPLL do the various long term weight loss measures increase similarly?.
There are of course many other questions now in bariatric surgery and related to the MGB/OAGB but the present study was designed to be sharply focused upon these two questions. Risk benefit and predictive power and multivariate analysis and creation of guidelines are in process and have been addressed in the past and will be part of subsequent publications., , ,
Notably the government of India health-care system provides no support for bariatric surgery and specifically no support at all for the MGB at any time during the course of this study and up until the time of this writing. All patients in the study paid out of pocket for the operation. The self pay situation and the fact that poor outcomes are little tolerated are also worthwhile noting. Given this climate and the capped hospital resources in a small town, it has been remarkable that the surgeons in this study have maintained a sterling record of excellent outcomes, a busy clinical practice with outcomes and results that rival those reported from other areas of the world including some of the best hospitals in the United States. The "tailored" MGB-OT used by the surgeon authors facilitated excellent outcomes and supported their success even in such demanding circumstances.
Once a significant association between BPLL and outcomes was determined, then a linear regression analysis was performed to further quantitate and describe the relationship between BPLL and outcome measures.
The present small first step is part of a longer term effort to investigate creation of a tool so robust that it might act as a guide for both patients and surgeons who might select the MGB-OT.
The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical permission was obtained from the local ethics committee and all participants provided written informed consent for data sharing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients selected for Mini-Gastric Bypass - Original Technique at Kular Hospital
Key inclusion criteria (0 listed)
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 Bypass - Original TechniqueAlso: Tailored Bilio-Pancreatic Limb LengthMini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL | Procedure or surgery | – |
Primary outcome
Percent Excess Weight Loss
Time frame: 10 years following operation
Amount of weight lost assessed by Percent Excess Weight Loss
Percent Total Weight Loss
Time frame: 10 years following operation
Amount of weight lost assessed by Percent of Total Weight Loss
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 19 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Obesity, Morbid
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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, Morbid and Weight Loss, 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 0 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 19 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?
Percent Excess Weight Loss (time frame: 10 years following operation). The study lists 2 primary outcomes in all. 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 19 Jun 2020.