ObesityNCT01401426
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
A study testing Laparoscopic vertical sleeve gastrectomy in people with Obesity and Nutrition Disorders, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Nutrition Disorders, Body Weight
- What is being tested?
- Laparoscopic vertical sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >40
- ASA I or II
Who cannot join
- Comorbid cardiac, pulmonary, renal, hepatic disease
- Bleeding disorder
- Previous gastric/esophageal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital Center
New York, New York, 10019
About this study
Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. The investigators have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.
- Conditions
- Obesity, Nutrition Disorders, Body Weight
- Being tested
- Laparoscopic vertical sleeve gastrectomy
- Keywords
- overweight, Obesity, Morbid
- Medical subject headings
- Obesity, Nutrition Disorders, Body Weight, Overweight, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic vertical sleeve gastrectomyProcedure or surgery
Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.
Laparoscopic vertical sleeve gastrectomyProcedure or surgery
Laparoscopic vertical sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Single incision laparoscopic vertical sleeve gastrectomy | Active comparator | Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision. Receives: Procedure: Laparoscopic vertical sleeve gastrectomy |
| Five port laparoscopic vertical sleeve gastrectomy | Active comparator | Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions. Receives: Procedure: Laparoscopic vertical sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 1 month and 1 year
Secondary outcomes (2)
Quality of life
Measured: 1 week and 3 months
Peri-Operative Complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401426
- Sponsor's protocol ID
- NCT01401426
- Status last verified
- May 2016
- First submitted
- 21 Jul 2011
- Last updated
- 19 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT01401426
- Acronym / sponsor ID
- NCT01401426
- Conditions
- Obesity, Nutrition Disorders, Body Weight
- Keywords
- overweight, Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Jul 2011 (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.
Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. The investigators have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single incision laparoscopic vertical sleeve gastrectomy | Active comparator | Procedure: Laparoscopic vertical sleeve gastrectomyActive Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision. |
| Five port laparoscopic vertical sleeve gastrectomy | Active comparator | Procedure: Laparoscopic vertical sleeve gastrectomyPatients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >40
- ASA I or II
Key exclusion criteria (3 listed)
- Comorbid cardiac, pulmonary, renal, hepatic disease
- Bleeding disorder
- Previous gastric/esophageal 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 |
|---|---|---|
| Laparoscopic vertical sleeve gastrectomyLaparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity. | Procedure or surgery | Single incision laparoscopic vertical sleeve gastrectomy |
| Laparoscopic vertical sleeve gastrectomyLaparoscopic vertical sleeve gastrectomy | Procedure or surgery | Five port laparoscopic vertical sleeve gastrectomy |
Primary outcome
Weight Loss
Time frame: 1 month and 1 year
2 secondary outcomes
Quality of life
Time frame: 1 week and 3 months
Peri-Operative Complications
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic vertical sleeve gastrectomy in people with Obesity and Nutrition Disorders, run by St. Luke's-Roosevelt Hospital Center at 1 site 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 May 2016. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Weight Loss (time frame: 1 month and 1 year). 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 May 2016.