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LONG BRANCH, NJ – A new incisionless procedure designed
to reduce the size of the stomach pouch and opening to the small
intestine in Roux-en-Y gastric bypass (RYGB) patients who have
started to regain weight because of changes in their anatomy
appears safe, effective and durable, according to the results
of a 21-patient series performed at Monmouth Medical Center,
an affiliate of the Saint Barnabas Health Care System. Patients
have been followed for up to a year.
Frank Borao, M.D., FACS, Chief of Minimally Invasive Surgery
and Medical Director for the Bariatric Surgery Program of Monmouth
Medical Center, presented the results in a podium session at
the 2009 Society of American Gastroenterological and Endoscopic
Surgeons (SAGES) Scientific Session & Postgraduate Course,
held in Phoenix, Arizona on April 22.
“After reviewing the 12-month images, I believe we have
created the first and only durable incisionless revision procedure
available to patients today,” Dr. Borao said.
In 2008, Monmouth Medical Center became one of the first hospitals
in the United States and the only hospital in New Jersey to offer
an incisionless procedure to reverse weight gain after gastric
bypass surgery. Steven Gorcey, MD, division chief of Gastroenterology
at Monmouth Medical Center and Frank Borao, MD, chief of Minimally
Invasive Surgery and medical director of Monmouth’s Bariatric
Surgery Program, performed the first two procedures on February
29, 2008. The incision-free procedure reduces the size of a patient’s
stomach pouch and stoma to the original post-gastric bypass proportions.
Gastric bypass surgery, also referred to as GBS or RYGB, offers
the most effective means possible to lose weight. It is not,
however, always a permanent fix. Up to half of all patients who
undergo gastric bypass begin to regain weight – and the
dangerous co-morbidities associated with it – a few years
after their initial operation. Studies show that post-gastric
bypass weight regain sometimes occurs because the stomach pouch
and the opening to the small intestine slowly stretch out, allowing
the patient to eat more without feeling full. Invasive procedures
to restore the anatomy to the original post-surgery proportions
have been too complicated and dangerous for most patients, leaving
them without any feasible treatment options.
“Gastric bypass patients work very hard to manage their
weight and adjust their lifestyle after surgery,” Dr. Gorcey
said. “Sometimes, through no fault of their own or their
surgeon, the benefits of the bypass procedure are not permanent.” He
added, “To date, revision options have been expensive,
difficult to perform and risky for the patient, effectively leaving
them without any treatment options. Now, with the new incisionless
procedure being offered at Monmouth Medical Center, we have a
new and dramatically less invasive way to correct a key cause
of weight regain.”
By eliminating skin incisions, this new procedure, which physicians
have coined “ROSE” (Restorative Obesity Surgery Endolumenally),
may provide important advantages to patients including reduced
risk of infection and associated complications, less post-operative
pain, faster recovery time and no abdominal scars.
Six months following the incisionless revision procedure, patients,
on average, had lost 29% of the weight they had regained; one
patient in the study lost 48 lbs during that six-month time period. Twelve-month
post-op endoscopies confirmed the durability of the procedure:
the tissue anchors remained in their original locations, most
of the intra-operative stoma and pouch reduction was preserved
and durable tissue folds were present. There were no significant
complications.
“Studies show that 35 to 50 percent of patients who undergo
gastric bypass begin to regain weight. This often occurs because
the stomach pouch and the opening to the small intestine (the
stoma) slowly stretch out, allowing the patient to eat more without
feeling full,” Dr. Borao said. “Current invasive
procedures to restore the anatomy to the original post-surgery
proportions have been too complicated and dangerous for most
patients, leaving them without any feasible treatment options. Given
the results of this series, this incisionless procedure has great
potential as a safe, durable, and efficacious method for reducing
stoma and pouch dilatation post-RYGB, filling a significant unmet
medical need in this patient population.”
To perform this new incisionless revision procedure, Dr. Borao
and his team used a small, flexible endoscope and USGI Medical,
Inc.’s Incisionless Operating Platform™ (IOP). The
scope and the IOP are inserted through the mouth and into the
stomach pouch. The IOP tools are then used to grasp tissue and
deploy suture anchors to create multiple, circumferential tissue
folds around the stoma, reducing the diameter of the opening
to more closely match original post-gastric bypass proportions. If
needed, additional anchors are then placed in the stomach pouch
to reduce its volume capacity. No cuts are made into the patient’s
skin during the procedure and patients reported little or no
pain after the procedure.
Prior to undergoing the Incisionless procedure, the surgeons
performed upper endoscopies to confirm that these patients’ pouches
and stomas had dilated since their original surgery. Dr.
Borao and his Monmouth team we were able to successfully place
anchors in 20 of 21 patients. On average, the Incisionless procedure
reduced the diameter of the 20 patients’ stomas by 53%
and their pouches by 41% with an average of 5.3 anchors placed
per case. Operating time averaged 91 minutes.
Upper endoscopies performed three months after the incisionless
procedure confirmed the presence of anchors in their original
locations, preservation of most of the intra-operative stoma
and pouch reduction, and presence of durable tissue folds. To
date, four patients have completed their 12-month post-op endoscopies
with findings consistent with the three month exam. The Monmouth
team continues to track weight loss through ongoing clinical
follow-up.
The Bariatric Surgery Program at Monmouth Medical Center makes
a long-term commitment to patients’ health and guides them
from pre-surgery consultation and testing through surgery, recovery
and continuing support. Monmouth Medical Center specializes in
laparoscopic weight-loss surgery including adjustable gastric
lap banding and Roux-en-y Gastric Bypass.Dr. Borao is board-certified
and fellowship trained in advanced laparoscopic surgery and has
been a pioneer in weight loss surgery in New Jersey. As a leader
in the field, he has since trained many other surgeons throughout
the state in bariatric laparoscopic techniques. For more information
on the Bariatric Surgery Program at Monmouth Medical Center or
the ROSE procedure, or to schedule a consultation, call (732)
923-6990 or visit www.mmcsurgery.com/bariatricsurgery.
About Incisionless Surgery
Incisionless Surgery is the next wave in minimally invasive
surgery and is rapidly becoming an option demanded by patients,
insurers and healthcare providers for its potential to minimize
pain, shorten hospital stays, lower treatment costs and eliminate
visible external scars. Incisionless Surgery, which encompasses
Natural Orifice Translumenal Endoscopic Surgery (NOTES), endolumenal
and single-port techniques, can be applied bariatric surgery,
cholecystectomy, appendectomy, GERD (Gastroesophageal Reflux
Disease), gastrointestinal cancer and urological and gynecological
procedures.
About the USGI Incisionless Operating Platform™ (IOP)
USGI Medical designed the Incisionless Operating Platform™ (IOP)
to enable Incisionless Surgery. Combining the flexibility
of endoscopy with the therapeutic benefit of laparoscopy, the
IOP offers a stable operating platform, a level view of the operating
field and access for multiple, robust, flexible surgical tools – important
requirements for Incisionless Surgery that traditional endoscopes
and endoscopic instruments do not provide. The IOP incorporates
the TransPort™ Operating Platform and instruments for cutting,
suturing and grasping tissue. The surgeon advances the
TransPort into the body in its flexible state to conform to the
patient’s anatomy, and then locks it into place to create
a stable operating field. The surgeon can then transport a camera
and the various tools though the TransPort’s four operating
channels, steer the end of the device to visualize a site, and
perform surgery with control and efficiency.
Date: April 23, 2009
CONTACT: Kristine A. Brown
Director of Public Relations
732-557-3902
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