Mr Michael Van
Consultant general surgeon, Spire Southampton Hospital, Southampton, UK
Until the mid-1980s, all surgery was done through a large incision. The advent of laparoscopic surgery transformed the world of surgery. Although the development of laparoscopic surgery was not specifically intended for bariatric surgery, it caused a revolution in this subspecialty, which ‘came in from the cold’ and took centre stage.
Some of the milestones include the first laparoscopic gastric banding procedure in 1992 by Dr Guy Bernard-Cadiere (Belgium)1 and the first laparoscopic gastric bypass in 1993 by Dr Alan Whitgrove (US).2 Since then, bariatric surgery has seen an exponential growth, with hundreds of thousands of operations carried out worldwide.
The never-ending quest for less invasive techniques gave birth to procedures like single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES). These techniques still require at least one incision to enter the abdominal cavity either through the vagina, rectum or umbilicus. Again, these techniques or procedures were not intended for the performance of bariatric surgery but the technology was quickly adopted by pioneering bariatric surgeons.
The last decade also witnessed the development of innovative endoluminal incisionless surgical techniques focused solely on bariatric surgery. The pandemic of obesity and diabetes with its spiralling costs and the realisation that bariatric surgery is the only effective treatment has provided the platform for innovation. Some of these techniques or procedures are on the verge of penetrating clinical practice.
Until now, incisionless procedures have only been used in pilot studies at single centres or in multi-centre trials with fairly limited numbers. None of these procedures have been adopted as a routine standard treatment in clinical practice. The technology works and is safe, but the evidence with regard to long-term outcomes is missing.
Primary incisionless procedures
1. Transoral Endoluminal Gastroplasty Techniques
TOGA ™ (SatietyInc, Palo Alto, California, USA) – Transoral gastroplasty
This operation is done with the help of a special gastroscope and a sleeve stapler that passes through the gastroscope. In essence, the stapler permits the construction of a narrow restrictive channel along the lesser curve of the stomach. Moreno et al reported in 2008 that this procedure is safe and feasible with significant weight loss in morbidly obese patients.3
POSE ™ (USGI Medical, San Clemente, California, USA) – Primary Obesity Surgery, Endoluminal
The POSE procedure is performed using a small flexible endoscope and the Incisionless Operating Platform (IOP). The scope and the IOP instruments are inserted through the mouth into the stomach the same way as a standard endoscope. Tissue anchors are used to create multiple tissue folds in the stomach to reduce its capacity. These folds in your stomach reduce the amount of food it can hold so you feel fuller faster during meals and eat less.
The technology behind this procedure is identical to the ROSE procedure. The first POSE procedures in Europe were carried out in August 2010 at the SPIRE Southampton hospital.
TERI (BaroSense Inc, Milo Park, California, USA) – Transoral Endoscopic Restrictive implant
This system uses endoscopic guidance to implant a restrictive reservoir just distal to the gastro-esophageal junction to induce early and prolonged satiety in obese and morbidly obese patients. Early feasibility and safety results are encouraging.
2. Endoluminal sleeves
EndoBarrier™ (GI Dynamics Inc, Lexington, Massachusetts, USA) – Also known as the Duodenal-Jejunal Bypass Sleeve
This is a single-use device that mimicks a duodenal-jejunal bypass. A standard gastroscope is used to position this device. The device consists of a nitinol anchor to fix the proximal end of the sleeve in the duodenum and a 60cm-long impermeable sleeve extending into the proximal jejunum. Food passes through the sleeve without being in contact with the duodenal wall. Pancreatic juice and bile only mix with food after the sleeve. In this way, the EndoBarrier creates a bypass of the proximal intestinal tract.
Several studies have shown good short-term weight loss and an improvement of type-2 diabetes.4,5 The drawback of this device is that it has to be removed after six months.
ValenTx™ (ValenTx Inc, Carpinteria, California, USA)
This is also an endoluminal sleeve used to treat morbid obesity and type-2 diabetes. The sleeve is anchored at the gastro-esophageal junction and extends well into the jejunum. It acts like a restrictive gastric sleeve in combination with a duodenal-jejunal bypass.
Early experience has shown good tolerance, no significant complications and good short-term weight loss. Again, this device has to be removed after six months.
Revisional incisionless procedures
These techniques are being applied to patients who have experienced weight regain after previous gastric bypass surgery. Although the gastric bypass is still considered as the gold standard of weight-loss surgery, some patients (up to 30%) experience weight regain which usually starts after 18 to 24 months.6
The weight regain is explained by dilatation of the gastric pouch, which leads to stretching of the anastomosis between gastric pouch and small bowel and the efferent small bowel loop itself. As a result, the patients lose the feeling of restriction when eating. Overeating translates in weight regain.
Until now, the only option for these patients was to undergo open or laparoscopic revisional surgery. This revisional surgery is not only very expensive but is also associated with a higher rate of severe complications.
Endoluminal incisionless techniques have the potential to reduce the risk of revisional surgery and be very cost-effective. The following procedures are being used in the clinical setting:
Stomaphyx™ (Endogastric Solutions, Palo Alto, California, USA)
Dr Jacques Himpens (Belgium) performed the world’s first endoscopic pouch plasty after Roux-En-Y (RNY) gastric bypass in 2007.
This endoscopic tool is inserted and placed against the gastric wall to permit full thickness approximation of the gastric tissue. These gastric folds are then plicated (pleated) by deploying polypropylenes fasteners resulting in a reduction of the size of the gastric pouch. Short-term weight loss is in the order of 20%.7
ROSE (USGI Medical, San Clemente, California, USA)
The ROSE procedure is performed using a four-channel tube – incisionless operating platform (IOP) – and special incisionless surgery tools. The surgeon advances a flexible tube and a small endoscope through the patient’s mouth, into the stomach pouch. The surgeon then inserts the surgical tools through the channels of the tube. The tools allow the surgeon to grab and lift folds of stomach tissue. Tissue anchors are used to create multiple tissue folds around the stoma, reducing the diameter. The surgeon will then use the same technique to place anchors in the stomach pouch to reduce its volume.
A multi-centre study of the ROSE procedure, approved by an institutional review board (ethics committee), has enrolled 116 patients in nine US centres with a mean reduction of stoma diameter of 50% and a mean reduction of pouch length of 44%. At six months, the patients had lost 32% of the weight that had been regained after RNY gastric bypass.8
Mr Michael Van den Bossche carried out the first ROSE procedures in Europe at the SPIRE Southampton hospital in July 2010.
Of all the incisionless techniques, the IOP and its instrumentation resembles most the traditional operating technique whereby the surgeon uses his two hands, as when suturing. With the IOP instruments, the surgeon can carefully choose which tissue he wants to plicate. The whole process is done under direct vision, which allows total control.
The procedures are currently done under general anesthetic in a theatre setting. The hospital stay is less than 24 hours and includes one overnight stay. With growing experience, day-case surgery will probably become the norm.
As with all new techniques, patient selection and training will be key to achieve favorable results. USGI Medical runs a superb training course at the Methodist Institute For Technology Evaluation (MITE) in Houston, Texas, USA. The course runs over two days and includes lectures, hands-on training stations and live surgery on pigs. US experts provide one-to-one tuition. All surgeons are committed to audit their work and enter their data in a register.
In conclusion, incisionless surgery is a challenging development in bariatric surgery. Whether any of the above-mentioned techniques will become mainstream remains to be seen. What is certain is that the quest for less invasive surgical modalities will continue.
- Cadiere GB et al. Br J Surg 1994;81:1524
- Wittgrove A et al. Obes Surg 1994;4:353-7
- Moreno C et al. Endoscopy 2008;40:406-13
- Tarnoff M et al. Surg Endosc 2008;23:650-6
- Schouten R et al. Ann Surg 2010;251(2):236-43
- Christou NV et al. Ann Surg 2006; 244:734-40
- Mikami D et al. Surg Endosc 2010;24:223-8
- Horgan S et al. SOARD 2010;6:290-5