Surgical Procedure

Pre-operative Assessment: After medical clearance is obtained, appropriate anatomical studies are performed such as an upper endoscopy and/or an upper gastrointestinal series to identify any pathology within the foregut. Additionally, appropriate antiembolic precautions should be taken and all appropriate antibiotics should be administered.

Placement of BariClip™ requires advanced laparoscopic skills and surgeons planning its placement must have extensive advanced laparoscopic experience as well as previous experience in the surgical treatment of obesity. Training in the operative techniques required to implant the BariClip™ is mandatory. The following instructions provide salient points for the BariClip™ use and are not intended to replace comprehensive training. 

Anesthesia: Regular General endotracheal anesthesia is used. An orogastric tube is typically placed after intubation in order to empty the stomach, and then removed.

Position of the Patient: The patient is commonly placed in moderate reverse Trendelenburg position to enhance visualization of the upper portion of the stomach.

Pneumoperitoneum:   The   laparoscopic   procedure   is   performed   under   carbon   dioxide pneumoperitoneum. Pneumoperitoneum is usually established to a pressure of 15 mm Hg, and is constantly monitored.

Position of the Trocars: Trocars need to be positioned high on the patient’s abdomen, and they must be inserted so that they angle toward the stomach for better instrument access in the severely obese abdomen. A trocar is placed at the umbilicus (or periumbilically) and four (4) other trocars are placed higher on the abdominal cavity, with one trocar used for passage of a liver retractor.

Surgical   Procedure:   An   articulating   dissector   is   used   to   separate   the   stomach   from   the diaphragm at the level of the angle of His. Directly inferior to the incisura angularis, a 5 – 6 cm area of omemtum on the greater curvature is dissected creating a window into the lesser sac.

Note: If a Hiatal Hernia is identified, it should be repaired before BariClip™ placement.

BariClip™ Dissection Technique

An articulating dissection device is  passed through the umbilical (or periumbilical) trocar though this omental defect into the lesser sac in a retrogastric fashion.  Attention must be placed to pass the dissector to the left of the left gastric vessels, and to the right of the short gastric vessels.  Commercially available surgical graspers or clamps are recommended for the proper insertion, positioning, and latching of the BariClip™ device. At this juncture, the dissector device is flexed upwards finishing the separation of the stomach to the diaphragm coming out at the previously dissected area at the angle of His.

BariClip™ Distal Dissection Point

The flexible tip of the BariClip™ (silicone strap) is attached by sutures to the articulating device. The sutures are cut and the strap is now pulled around the angle of His, ensuring that the posterior limb of the BariClip™ is now behind the stomach

BariClip™ Location

Now, the anterior limb of the BariClip™ is flipped forward, thus lying on the anterior surface of the stomach. At this point the latch on the anterior limb of the BariClip™ is passed through one of the two adjustment level latches (usually the lowest) in the strap, and the BariClip™ is closed.

To ensure an adequate gastric lumen, the anesthesiologist must pass a bougie, usually 3 F into the antrum. Making sure not to place too much upwards and/or lateral tension on the stomach so as not to diminish  the gastric lumen, especially at the level  of the incisura angularis, seromuscular   sutures  are   placed,  at   the  indented   (anchoring)  areas   on  the  BariClip™  to maintain the device in position and minimize the risk of slippages. The recommended suture size for properly anchoring the device onto the stomach tissue is a 2-0 non absorbable suture. 

Seromuscular   sutures   are   placed   at   the   indented   (anchoring)   areas, both   anteriorly   and posteriorly, to maintain the device in position. Additionally, inferiorly, at the midlevel of the titanium-free silicone only covered outlet of the BariClip™, gastro-gastro seromuscular sutures are used to cover this area, both anteriorly and posteriorly, to prevent movement of the inferior portion of the BariClip™ towards the duodenum (slippage).

BariClip™ Placement and Latching

The anesthesiologist now removes the bougie. At this time, either an intraoperative gastroscopy, insufflation of air or injecting methylene blue via an orogastric tube is done to assure no leaks of the stomach and adequate patency of the gastric lumen. When   an endoscopy is performed the excluded stomach can also be examined, as the inferior B-clamp opening allows the gastroscope to pass through the inferior opening to the excluded area of the stomach.

BariClip™ Intraoperative Gastroscopy