Morbid ObesityNCT01703546
Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
A study testing LAGB & LGCP in people with Morbid Obesity, run by Northwell Health at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- LAGB & LGCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Nov 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) > 35
- Meet ASMBS and NIH criteria for Weight Loss Surgery
- ASA Class I - III
- Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
- English speaking \& comprehension
- Normal mental caliber.
Who cannot join
- Pregnancy, Liver failure or Kidney failure
- Women of childbearing potential lactating at the time of initial consult or at the time of surgery
- Any condition which precludes compliance with the study
- History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
Syosset, New York, 11791
Syosset Hospital, Center for Bariatric Surgical Specialties
Syosset, New York, 11791
About this study
Official title: Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.
Read the detailed description
Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.
- Conditions
- Morbid Obesity
- Being tested
- LAGB & LGCP
- Keywords
- Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAGB & LGCPProcedure or surgery
Also called Laparoscopic Adjustable Gastric Band & Gastric Plication
All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band \& Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.
| Study group | Role | What they receive |
|---|---|---|
| LAGB & LGCP | Experimental | All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB \& LGCP).
The percent of Excess Body Weight Loss will be monitored at all post op visits. Receives: Procedure: LAGB & LGCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Excess Body Weight Loss (%EWL)
Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.
Measured: 6 months post procedure
Secondary outcomes (1)
HgbA1c
A baseline HgbA1c will be obtained pre-operatively for study patients with a comorbid diagnosis of Type 2 Diabetes. HgbA1C will also be obtained at 6 months and 12 months to evaluate the change from the baseline HgbA1C.
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Barrett, Northwell Health
- Investigators
- Robert Ward, MD, Study chair, North Shore LIJ Health System, Syosset Hospital, Director of SurgeryAllison Barrett, MD, Principal investigator, North Shore LIJ Health System Syosset Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703546
- Sponsor's protocol ID
- 11-277A
- Status last verified
- Jan 2016
- First submitted
- 10 Aug 2012
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
- ClinicalTrials.gov ID
- NCT01703546
- Acronym / sponsor ID
- 11-277A
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Oct 2012 (estimated)
- 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.
The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.
Detailed description
Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAGB & LGCP | Experimental | Procedure: LAGB & LGCPAll study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB \& LGCP). The percent of Excess Body Weight Loss will be monitored at all post op visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body Mass Index (BMI) > 35
- Meet ASMBS and NIH criteria for Weight Loss Surgery
- ASA Class I - III
- Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
- English speaking \& comprehension
Key exclusion criteria (4 listed)
- Pregnancy, Liver failure or Kidney failure
- Women of childbearing potential lactating at the time of initial consult or at the time of surgery
- Any condition which precludes compliance with the study
- History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.
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 |
|---|---|---|
| LAGB & LGCPAlso: Laparoscopic Adjustable Gastric Band & Gastric PlicationAll study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band \& Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit. | Procedure or surgery | LAGB & LGCP |
Primary outcome
% Excess Body Weight Loss (%EWL)
Time frame: 6 months post procedure
Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.
1 secondary outcome
HgbA1c
Time frame: 12 months post procedure
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 14 Jan 2016.
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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.
Robert Ward, MD study chair
North Shore LIJ Health System, Syosset Hospital, Director of Surgery
Allison Barrett, MD principal investigator
North Shore LIJ Health System Syosset Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAGB & LGCP in people with Morbid Obesity, run by Northwell Health at 2 sites in United States.
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 6 inclusion and 4 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
% Excess Body Weight Loss (%EWL) (time frame: 6 months post procedure). 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 14 Jan 2016.