Comparison of Gastric Bypass and AspireAssist Aspiration Therapy for Treatment of Morbid Obesity
Comparison of Gastric Bypass and AspireAssist Aspiration Therapy for Treatment of Morbid Obesity
The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy
 over 5 years of treatment with regards to weight loss, quality of life, complications,
 adverse events, and health economics.
Overweight and obesity is increasing rapidly in Sweden and is the greatest threat to future
 public health. Obesity, defined according to the World Health Organization (WHO) as a body
 mass index (BMI) greater than 30 kg/m2, is an intractable disease in healthcare today.
 Obesity results in reduced life expectancy and increased morbidity.

 Weight reduction by lifestyle changes or with different pharmacological preparations have in
 many studies not made lasting long term results. Obesity surgery has so far been the only way
 to achieve permanent weight loss. During the 1980s, restrictive procedures were performed,
 e.g., vertical banded gastro-plasty (VBG) with good but unfortunately transient effect. Later
 developed, is the now prevalent gastric bypass procedure (GBP) which today uses the keyhole
 technique and causes combined restrictive and mal-absorptive changes in gastrointestinal
 anatomy.

 GBP is currently the standard method in clinical practice for the surgical treatment of
 morbid obesity (i.e., BMI over 35). GBP is a procedure that is not reversible, which entail
 certain pre - and postoperative risks. GBP quickly brings a sharp reduction in weight and
 also regression of diabetes mellitus type 2. Unfortunately, the surgery cause lifelong
 mal-absorption and requirements of vitamin and mineral supplements.

 Swedish Obese Subjects study (SOS) that emanated from Gothenburg was the first controlled
 intervention study of overweight individuals. Approximately 4000 patients were included, half
 of which were surgical, the other half were treated optimally, but without surgery. The
 patients have been followed for 10-20 years. Total mortality was 24% lower in the surgical
 group.

 A new alternative approach to obesity surgery, AspireAssist™ Aspiration Therapy System (CE
 Marked), comes from the United States and in this method the individual empties out digesta
 from the stomach. Percutaneous endoscopic gastrostomy (PEG) has been used internationally
 since the early 1980s for nutrition therapy for stroke or cancer. In a gastroscopy a tube is
 placed between the stomach and abdominal wall and nutrition administered via tube directly
 into the stomach.

 Aspiration treatment with AspireAssist™ empties food from the stomach after every meal to
 lose weight. Using a valve mechanism and associated tubing set and water reservoir the
 individual empties out digesta in the toilet 20 minutes after each meal and loses
 approximately 30% of the caloric intake in the diet. A 1 -year study in Karlskrona, Sweden,
 has shown a significant reduction in weight, almost 40% Excess Weight Loss (% EWL) reduction
 and median weight reduction of 16.5 kg after 6 months. For GBP the weight reduction of 1 year
 is in the order of 70-85 %. During 1 year of treatment with AspireAssist™ there were no
 serious complications or problems with the body's electrolyte balance noted either at the
 surgery or during follow-up. The advantage of this method is that it is completely reversible
 and the individual who does not wish to continue aspiration may have the tube into the
 stomach removed. GBP results in most of the stomach becoming disconnected and not accessible
 for the diagnosis of, for example, ulcers, bleeding, tumors or gall stones. AspireAssist™
 does not have any lasting changes in the anatomy and thus will not lead to the potential for
 internal hernia that GBP unfortunately can cause. Wound infection occurs in approximately 9 %
 of cases when PEG tubes are placed in patients with cancer or stroke. Wound infections are,
 in most cases, treatable with antibiotics in tablet form and are very rarely considered to be
 a serious complication. Antibiotics are routinely given in conjunction with PEG insertion.
 Very unusual complication is leakage associated with insertion of the PEG and the method has
 been reported to have a risk of about 2 % during PEG insertion.

 For the individual to get help to change their habits and their lifestyle, cognitive
 behavioral therapy (CBT) is included in the treatment concept for AspireAssist™. CBT program
 runs for six months and includes both group meetings and individual conversations and
 individual assignments between meetings. Group meetings will cover the following themes:
 motivation, vision workshop, self-esteem, thought management, stress, learn to eat
 consciously, prevent and manage relapse. The program uses no calorie reducing methods since
 there is no scientific evidence that these provide permanent results but are based on CBT.
 The program is enhanced with awareness and mental training, which are methods that have shown
 good results in stress-related conditions. Mindfulness Based Stress Reduction (MBSR) in one
 study has been shown to change brain activity of the participants so that the activity was
 shifted from the areas in the frontal lobe that is active during stress, anxiety and
 depression to areas that regulate peace, joy and curiosity.

 Randomization in clinical trial (RCT) had been the best way to implement such a comparative
 study. But AspireAssist™ method is aimed at patients who do not want or dare to be operated
 with Gastric Bypass Procedure (GBP) and therefore fails to randomization.

 We therefore recruit patients from the clinic's waiting list of accepted and planned the GBP
 and the other group comes from the existing waiting list for Aspire method to treat obesity.
 This group includes only those patients who expressed clearly that they are not willing or
 dare to be operated with GBP, but instead wishes to receive treatment with Aspire method for
 their morbid obesity.

 There are now newer statistical methods to compare two or more groups in an observational
 study in a good and statistically significant manner and Stata version 13 can handle it well
 by matching the so-called covariates (e.g., in our study may be covariates following
 variables at baseline: age, gender, preoperative weight, BMI, concomitant disease such as
 diabetes). Patients were matched and then the comparison is done between the matched groups.
 Calculation of treatment effects , including so-called propensity score exploitation has
 already been used in a comparative study between GBP and other bariatric surgery for obesity
 where neither has been able to randomize patients (Carlin et al Annals of Surgery, Vol. 257,
 Number 5, May 2013: 791-7)
Inclusion Criteria:

 -  age 20-60 years

 -  body mass index over 35

 -  the absence of an eating disorder

 -  severe co-morbidity

 -  failure to achieve weight loss with lifestyle changes or other conservative approaches

 Exclusion Criteria:

 -  Recent myocardial infarction (3 months)

 -  Ongoing cancer

 -  Chronic liver and / or kidney disease

 -  Mental illness, including substance abuse and eating disorders that can exclude the
 patient from aspiration therapy.

 -  Discovery of severe disease of the stomach on endoscopy