What this is about
Obesity is a chronic disease that increases the risk of conditions such as type 2 diabetes, high blood pressure and sleep apnoea. Bariatric surgery is considered an effective treatment. Yet only one to two per cent of people who would be eligible for surgery actually undergo it, the study team writes.
This is where endoscopic procedures come in. Endoscopic means through the mouth, without an incision in the abdominal wall. The stomach wall is folded from the inside and the folds are secured. The stomach becomes smaller, but no tissue is removed.
One such procedure is POSE 2.0. Via an endoscopic platform – a tube with a camera and several working channels – instruments grasp the stomach wall, gather it into a fold and secure it with suture anchors. Specialists refer to this as plication. Around 20 individual folds are created in this way in the middle and lower stomach; the dome of the stomach (fundus) is spared.
MEGA builds on POSE 2.0. The abbreviation stands for Endoscopic Gastric Mega-plication. Two grasping instruments take hold of the back wall and then the front wall of the stomach. The two folds are then grasped together and secured with a single pair of suture anchors. Each step thus creates a double fold, or double plication. Around six are planned. They extend from the level of the gastric angle in the lower stomach to around three centimetres below the point where the oesophagus enters the stomach. The aim: to make the stomach narrower and shorter, with fewer suture anchors and fewer steps.
How the study was designed
The study is retrospective, meaning it looks back: the study team analysed existing treatment data. The six participating centres, all experienced in the endoscopic treatment of obesity, were in Spain, Italy (two centres), the Netherlands, Austria and Germany. An ethics committee approved the analysis.
The study included adults with a body mass index (BMI) of 30 or more, or of 27 or more with at least one associated condition. BMI relates body weight to height. Patients with a BMI of 40 or more had to have been offered surgery beforehand and to have declined it. Anyone who had already had bariatric surgery or endoscopic sleeve gastroplasty, or who was taking or had taken weight-loss medication, was excluded. Nor was any weight-loss medication given alongside the procedure during the study.
Only patients with complete data after six months were analysed – 54 in total: 9 from Spain, 9 from Italy, 6 from the Netherlands, 12 from Austria and 18 from Germany. Of the 50 patients whose sex was recorded, 45 were women.
All procedures were performed under general anaesthesia with a planned hospital admission. A single experienced instructor had trained the doctors at the centres through workshops, live procedures and at least four procedures under supervision. All of them followed a common protocol.
After the procedure, patients received nutritional counselling with a gradual diet progression from liquid to solid food, along with advice on physical activity. Check-ups took place after 24 hours and after one, three and six months. The main focus was weight loss after six months as a percentage of starting weight, known as total body weight loss.
- Spain9
- Italy9
- Netherlands6
- Austria12
- Germany18
What the study found
All 54 procedures were completed as planned. In the five centres with data on this, an average of 6.4 double folds were created per procedure, and a procedure there took 31 minutes on average.
After six months, patients had lost an average of 14.8 per cent of their starting weight. The average BMI fell from 36.2 to 30.9.
Of the 54 patients, 44 – or 81.5 per cent – lost at least ten per cent of their weight. The study regards this threshold as clinically meaningful. Ten patients remained below it. The results varied: some lost considerably more, others considerably less.
There was no statistically significant difference in weight loss between the centres – according to the study team, an indication of consistent implementation, to which the shared training may have contributed. The number of double folds showed no measurable association with weight loss.
All patients were discharged within 24 hours. Over the six months, the study recorded no serious complications such as bleeding, perforation (a hole in the stomach wall) or an abscess (a collection of pus), no repeat procedures and no readmissions to hospital. Expected milder symptoms such as abdominal pain, nausea, vomiting or stomach cramps were treated, but their severity was not systematically recorded.
The results varied: some lost considerably more, others considerably less.
How to interpret the results
The study team itself describes the results as preliminary and names clear limitations:
- Retrospective. The data come from medical records. Age and ethnicity are missing; sex and associated conditions were only partially recorded.
- Small. 54 patients, between 4 and 18 per centre.
- No control group. According to the study, the results reflect the combined effect of the procedure and dietary follow-up. They do not allow a direct comparison with other procedures.
- Short. Six months cannot show whether the weight stays off in the long term.
- Not recorded consistently. Metabolic parameters, quality of life and milder symptoms.
According to the study team, the results are within the range of other established endoscopic procedures after a similar period. Robust conclusions, they say, would require larger prospective studies with longer follow-up. Prospective means that patients are followed from the start according to a fixed plan and examined in the same way.
The study shows how MEGA could be implemented in six experienced centres. It does not allow conclusions about any individual case.
