Morbid ObesityLGPNCT01293877
Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
A study testing Laparoscopy surgery for morbid obesity in people with Morbid Obesity, run by Bikkur Holim Hospital at 1 site in Israel.
Trial summary
The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopy surgery for morbid obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Mar 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 40 or more
- Age between 18-60 years old
- ASA score 1-2
Who cannot join
- BMI less than 40
- Severe illness
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Gastric Plication for Treatment of Morbid Obesity
The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.
Read the detailed description
The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopy surgery for morbid obesity
- Keywords
- Laparoscopy, obesity, gastric, restrictive
- 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.
Laparoscopy surgery for morbid obesityProcedure or surgery
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
| Study group | Role | What they receive |
|---|---|---|
| LGP | Other | Patient underwent surgery for morbid obesity treatment between 18 to 60 years, and BMI of 40 ore more will divided in two groups, one hundred will be schedule for laparoscopic gastric plication. Our theory for this arm is that the procedure can offer the same results than the second arm with less cost and safety, reversibility included. Receives: Procedure: Laparoscopy surgery for morbid obesity |
| LSG | Other | The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study. Receives: Procedure: Laparoscopy surgery for morbid obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass index loss
The body mass index will be compared before the procedure and after at time frames.
Measured: 6mont.
Secondary outcomes (1)
Complications Quality of life
complications compared one with the second procedure, qol, possibility to eat.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bikkur Holim Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sergio g Susmallian, dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293877
- Sponsor's protocol ID
- GP111BH
- Acronym
- LGP
- Status last verified
- Feb 2011
- First submitted
- 10 Feb 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Gastric Plication for Treatment of Morbid Obesity
- ClinicalTrials.gov ID
- NCT01293877
- Acronym / sponsor ID
- LGP / GP111BH
- Conditions
- Morbid Obesity
- Keywords
- Laparoscopy, obesity, gastric, restrictive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bikkur Holim HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 11 Feb 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.
The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.
Detailed description
The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGP | Other | Procedure: Laparoscopy surgery for morbid obesityPatient underwent surgery for morbid obesity treatment between 18 to 60 years, and BMI of 40 ore more will divided in two groups, one hundred will be schedule for laparoscopic gastric plication. Our theory for this arm is that the procedure can offer the same results than the second arm with less cost and safety, reversibility included. |
| LSG | Other | Procedure: Laparoscopy surgery for morbid obesityThe patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 40 or more
- Age between 18-60 years old
- ASA score 1-2
Key exclusion criteria (3 listed)
- BMI less than 40
- Severe illness
- Psychiatric disorders
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 |
|---|---|---|
| Laparoscopy surgery for morbid obesityThe intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/ | Procedure or surgery | LGP, LSG |
Primary outcome
Body Mass index loss
Time frame: 6mont.
The body mass index will be compared before the procedure and after at time frames.
1 secondary outcome
Complications Quality of life
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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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.
Sergio g Susmallian, dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy surgery for morbid obesity in people with Morbid Obesity, run by Bikkur Holim Hospital at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Feb 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio G Susmallian, dr (+972524637743, sergio9@bezeqint.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass index loss (time frame: 6mont.). 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 11 Feb 2011.