Morbid ObesityNCT01207609
Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
A study testing Laparoscopic Gastric Plication in people with Morbid Obesity, run by Ponce, Jaime, M.D. at 2 sites in United States.
Trial summary
The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity. The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic Gastric Plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Jan 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 60 years
- BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2
- Willingness to comply with dietary restrictions required by the protocol
- History of obesity for at least 5 years
- History of at least 6 months of documented failures with traditional non-surgical weight loss methods
- Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire
- If female with childbearing potential, using an appropriate form of contraception
Who cannot join
- Age less than 18, age greater than 60
- Pregnancy
- History of major depressive disorder or psychosis
- Previous bariatric surgery or previous gastric surgery
- Presence of achalasia
- Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chattanooga Bariatrics
Chattanooga, Tennessee, 37421
Hamilton Medical Center
Dalton, Georgia, 30722
About this study
Official title: A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.
The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.
Read the detailed description
The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic Gastric Plication
- Keywords
- Obesity, Morbid Obesity, Bariatric Surgery, Laparoscopic Gastric Plication
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Gastric PlicationProcedure or surgery
Also called Laparoscopic Greater Curvature Plication, Vertical Gastric Plication, Gastric Sleeve Plication
The procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. A calibration tube or endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Gastric Plication | Experimental | Collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity Receives: Procedure: Laparoscopic Gastric Plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of excess weight loss
The primary efficacy variable is weight loss, which is measured in pounds and evaluated in terms of % excess weight loss (EWL) and body mass index (BMI), both of which will be measured at each follow-up visit.
Percent EWL is calculated by the following equation: [Weight Lost]/ [(Pre-op Weight)-(Ideal Body Weight)]. BMI is calculated by the equation: Weight (kg) divided by Height (m) squared [kg/m2].
Measured: 3 years
Secondary outcomes (3)
Status of comorbid conditions
Improvement, resolution or worsening of pre-operative co-morbidities will be evaluated and reported at one year and annually up to 3 years. Status will be evaluated according to the necessity of medications to maintain normal physiologic values such as fasting serum glucose in diabetic patients, normal blood pressure in hypertensive patients, and use of a CPAP machine for patients with obstructive sleep apnea.
Measured: 3 years
Changes in quality of life scores from base line
Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey
Measured: 3 years
Adverse events
Adverse events are intended to be volunteered by subjects or observed by the investigator. All adverse events are to be recorded on appropriate case report forms.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ponce, Jaime, M.D.
- Responsible party
- Principal investigator, Jaime Ponce MD, Ponce, Jaime, M.D.
- Investigators
- Jaime Ponce, MD, Principal investigator, Hamilton Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207609
- Sponsor's protocol ID
- 10-9-001
- Status last verified
- Feb 2016
- First submitted
- 21 Sep 2010
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg. 2010 Jul;20(7):913-8. doi: 10.1007/s11695-010-0132-0.
PubMed 20407932
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
- ClinicalTrials.gov ID
- NCT01207609
- Acronym / sponsor ID
- 10-9-001
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Morbid Obesity, Bariatric Surgery, Laparoscopic Gastric Plication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ponce, Jaime, M.D.
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Sep 2010 (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 study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.
The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.
Detailed description
The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Gastric Plication | Experimental | Procedure: Laparoscopic Gastric PlicationCollect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 - 60 years
- BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2
- Willingness to comply with dietary restrictions required by the protocol
- History of obesity for at least 5 years
- History of at least 6 months of documented failures with traditional non-surgical weight loss methods
Key exclusion criteria (6 listed)
- Age less than 18, age greater than 60
- Pregnancy
- History of major depressive disorder or psychosis
- Previous bariatric surgery or previous gastric surgery
- Presence of achalasia
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 |
|---|---|---|
| Laparoscopic Gastric PlicationAlso: Laparoscopic Greater Curvature Plication, Vertical Gastric Plication, Gastric Sleeve PlicationThe procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. A calibration tube or endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure. | Procedure or surgery | Laparoscopic Gastric Plication |
Primary outcome
Percent of excess weight loss
Time frame: 3 years
The primary efficacy variable is weight loss, which is measured in pounds and evaluated in terms of % excess weight loss (EWL) and body mass index (BMI), both of which will be measured at each follow-up visit. Percent EWL is calculated by the following equation: [Weight Lost]/ [(Pre-op Weight)-(Ideal Body Weight)]. BMI is calculated by the equation: Weight (kg) divided by Height (m) squared [kg/m2].
3 secondary outcomes
Status of comorbid conditions
Time frame: 3 years
Changes in quality of life scores from base line
Time frame: 3 years
Adverse events
Time frame: 3 years
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 2 Feb 2016.
- Background: PubMed 20407932Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg. 2010 Jul;20(7):913-8. doi: 10.1007/s11695-010-0132-0.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
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.
Jaime Ponce, MD principal investigator
Hamilton Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Gastric Plication in people with Morbid Obesity, run by Ponce, Jaime, M.D. 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 7 inclusion and 6 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 2 Feb 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?
Percent of excess weight loss (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207609, which also lists 1 linked publication.
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 2 Feb 2016.