Enrolling now: these trials range from studies where surgical treatments for obesity are offered free of charge, to others where we measure the effects of obesity and other treatments. All are being run under the supervision of Human Ethics Committees. Please email info@uppergisurgery.com.au for information, or ring 02 95531120 and ask to speak to Tania.
Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
CP-0020
Background
Most patients who are obese enough to consider surgery for their disease decide against it because of their concerns about the reversibility of the operations or worry about side effects. The laparoscopic sleeve gastrectomy and laparoscopic gastric bypass involve either removing or dividing internal organs, and the laparoscopic gastric band can lead patients to vomit when they eat, and the device can lead to damage of the stomach and oesophagus that persists even though the device itself can be removed. This new laparoscopic treatment is now in its fourth year of development and we have been placing it in patients over the last two years. Preliminary results show similar weight loss to that obtained by patients having laparoscopic gastric bands, but without the problems of vomiting or injury to the stomach.
Costs.
This treatment is available to patients with or without health insurance. Costs of treatment and follow-up will be covered.
The Trial.
Patients who wish to be considered for the trial will undergo assessment to make sure there are no medical problems that would make the operation risky or unlikely to work. The operation involves placing an inflatable, removable implant which is “stomach shaped” into the abdomen and placing it over the front of the stomach.
This prevents the stomach from expanding when you eat which limits your capacity. For those people familiar with weight-loss operations, what is being created is similar to an “adjustable sleeve gastrectomy”. As the stomach lies mostly above the ribcage, the device fills up this space rather than making your abdomen bulge when it is inflated. The volume that the stomach can expand to is limited to about a cup full of food, compared to its normal capacity of > a litre.
Enrolment for this trial will be completed in about a month. Please email info@uppergisurgery.com.au or phone Tania on 02 95531120 for further information.
A Prospective, Multi‐center Clinical Evaluation to Assess Safety and Performance of CAVU Medical, Inc.’s Attune Tubing When Used With
Newly‐implanted Laparoscopic Adjustable Gastric Bands (LAGBs)
Protocol Number: TP0271, REV. B
Background.
Some of the main concerns that patients have about the Gastric Band relate to difficulty in getting the adjustments “just right”. A Band that is too loose doesn’t restrict hunger enough, and a band that is too tight will make someone vomit when they eat. There is also a concern that even when a band is adjusted correctly some patients will experience vomiting if they eat too quickly, or if they eat food that is too lumpy.
Costs
While patients will need to have health insurance in order to have the surgery, we will be able to offer patients payment for many of their follow-up costs.
The Trial
The Attune Tubing has been designed with the following aims in mind
A) To make Band adjustments last longer by creating a reservoir for fluid under pressure to be stored in.
B) To reduce the risk of vomiting by both preventing the band from getting too tight after an adjustment, and by allowing the band to “decompress” into the reservoir if food gets stuck inside the band.
Attune Device
In order to see if the device has the desired effect we are planning to attach it to Gastric Bands at the time patients are having one put in. After the operation patients will be looked after the same way as normal Gastric Band patients, except we will want them to have more regular follow-up, answer questions regularly in order to determine how the device is working, and have pressure measurements taken of the band when they have adjustments.
While the ultimate aim is to improve the experience for patients having Laparoscopic Gastric Band surgery we cannot know if individuals partaking in the trial will experience any benefit themselves.
Please email info@uppergisurgery.com.au or phone Tania on 02 95531120 for further information.
Changes in Metabolic Rate, Dietary Intake and Body Composition following Bariatric Surgery
Background
When people try to lose weight they can be surprised about how long it takes for their weight to come off and how it seems the more they lose the harder it is for further kilos to be shed. The relationship between what you eat, your metabolic rate, and the changes that weight loss causes in your body is the focus of this trial.
Costs
We are able to provide the body composition, metabolic rate and dietary analysis free of charge to patients enrolled in the study.
The Trial
Prior to and following weight loss surgery (of your choice) we will measure your body composition, metabolic rate and food intake. These tests are quick, painless and very very low in risk. Our aim is to collate data to provide patients with information that can guide them during the weight loss process.
Please email info@uppergisurgery.com.au or phone Tania on 02 95531120 for further information.
Collaborative Studies.
These are studies where we work with other research teams. Working with others helps when you want to enrol a large number of patients, and helps engage expertise from other specialist teams.
Genetics of Obesity Study – Garvan Institute of Medical Research
Background
A study to screen for a gene linked to obesity is being conducted at the Garvan Institute. It involves only one visit during which measurements and a blood test will be taken. If you are suitable, you may enter the second part of the study to receive a full metabolic assessment.
The Trial
Overweight volunteers (ie body mass index > 30) are needed to participate in a study screening for a gene which links to obesity.
During a preliminary visit, a blood test and various body measurements will be taken to assess your suitability for the study. If you match our criteria, we would invite you back for a full metabolic assessment.
Why are we doing this study?
The gene in question (MC4R) is present in up to 6% of overweight people – and is associated with greater appetite, predisposing people to obesity from childhood. The gene is also associated with lower blood pressure than might be expected .
There are different kinds of obesity – with some people remaining metabolically healthy, while others become susceptible to high cholesterol, high blood pressure and Type 2 diabetes. We are interested in finding out as much as possible about why such differences occur.
Our research might help future screening of obese people to identify those who are predisposed to illness, and those who are not.
Anticipated recruitment is April 2011 to April 2012
Enquiries:
Dr Daniel Chen (02) 9295 8557 or d.chen@garvan.org.au
Research Nurse Vanessa Travers (02) 9295 8232 or v.travers@garvan.org.au
The association between NPY peptide/ Gut Hormones and skeletal health
Background.
Patients who are very overweight often have surprisingly weak bones given their size. There is a concern also that weight-loss and weight-loss surgery may on occasions lead to further bone weakening, but this has not been well studied in the past.
Costs
Transport and parking costs will be covered, as are the tests undertaken.
The Trial
Patients who are planning to have weight-loss surgery (gastric band, gastric bypass, sleeve gastrectomy) who wish to know more about their bone health will be assessed before and after surgery to see what their bone strength is, whether weight-loss affects their bones, and what blood hormones change during the weight loss process.
For people interested in being considered for the study, the researcher Dr Gosia Brzozowska will discuss it with you and any queries you may have. If you would like to know more at any stage, please do not hesitate to contact her through the Garvan Institute of Medical Research on (02) 92958240.
Fully Enrolled: A Prospective, Multi-Center Clinical Evaluation to Observe the Intra-band Pressure Variances in Newly Implanted Laparoscopic Adjustable Gastric Bands (LAGB) Between Adjustments
Protocol Number: TP0174
In this trial we are interested in measuring the pressure inside gastric bands when patients come in for adjustment of the device. We know that putting fluid into a band (an adjustment) increases the pressure in the band as it squeezes the upper stomach, but we are unsure how long this raised pressure lasts for, and how the increase in pressure relates to patients feelings of hunger and their desire to eat. In this study we measure the pressure inside bands before and after adjustments and ask patients to record their feelings of hunger. We have now ceased enrolling patients in this study.
