None listed
Conditions
Brief summary
The laparoscopic sleeve gastrectomy (LSG) is currently the most commonly performed bariatric procedure in Australia. Long-term data is beginning to appear in the literature and indicates that up to half of patients who have undergone the surgery regain a significant amount of weight in the years following the surgery. These patients often progress to have further surgery to promote more weight loss. In some patients, the regain in weight is thought to be caused by the stomach stretching in size and the patient can then eat more again. Some surgeons have started placing a silastic ring around the stomach with the original surgery to prevent the stomach from stretching. Long-term data on the efficacy and safety of inserting a ring with a sleeve gastrectomy is scarce. It is also possible that a ring may have an effect on reflux and what foods a person can tolerate. This study will be a randomised prospective study with the purpose of evaluating the efficacy of a silastic ring in preventing sleeve dilatation (stomach stretching) and deduce any effect on complication rate; reflux; and food tolerance. The study will provide three-year data to assist in determining whether a banded LSG (using a ring) should become the preferred surgical option for the treatment of obesity. Approximately 95 patients who undergo a banded LSG and 95 patients who receive a standard LSG will be followed for a period of thirty-six months. Patients will be randomised into one of the two study groups. Anthropometric and metabolic data will be collected pre-operative, and at 6, 12, 24 and 36 months after surgery. Food tolerance and reflux evaluated . Stomach capacity will be measured by a Computerised Tomography (CT) Fizzogram at 36 months post-operative. Participants will be asked to have a nasopharyngeal 24 hr pH probe placed at 36 months’ post-operatively irrespective of symptoms as per current clinical practice. Patients presenting before 36 months with weight regain and /or symptomatic reflux will have a CT Fizzogram or oropharyngeal pH monitoring performed earlier, as per normal clinical practice.
Interventions
The intervention is the placement of a Minimizer Ring (a silicone ring) at the time of a laparoscopic sleeve gastrectomy (LSG). The ring is placed by a bariatric surgeon with approximately 10 years experience at performing LSGs and approximately 4.5 years experience of placing the Minimizer Ring. The ring is placed around the sleeve (stomach remnant) immediately after the excised stomach is removed during a LSG thus in surgical theatre under a general anaesthesia. Patients will be randomised int
The intervention is the placement of a Minimizer Ring (a silicone ring) at the time of a laparoscopic sleeve gastrectomy (LSG). The ring is placed by a bariatric surgeon with approximately 10 years experience at performing LSGs and approximately 4.5 years experience of placing the Minimizer Ring. The ring is placed around the sleeve (stomach remnant) immediately after the excised stomach is removed during a LSG thus in surgical theatre under a general anaesthesia. Patients will be randomised into two goups - one that recieves the ring and one that does not. The ring is placed loosely around the sleeve at a typical diameter of 8cm. If the ring cannot be fixed loosely, it will not be placed. Currently this is a rare occurrence. The progress of all patients will then be monitored for 3 years after surgery.
Sponsors
Ass. Prof. Harsha Chandraratna
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients eligible for a primary LSG aged 18-65yrs and who present to the clinic without already having determined if they do or do not wish to have a Minimizer Ring placed.
Exclusion criteria
Patients who cannot attend appointments primarily due to geographical restraints eg. live remotely and do not visit Perth regularly
Outcome results
None listed