Early OSU experience of endoluminal gastric pouch reduction surgery with Stomaphyx

1. Surg Endosc
DOI 10.1007/s00464-009-0640-y
ENDOLUMINAL SURGERY
Natural orifice surgery: initial US experience utilizing
the StomaphyXTM device to reduce gastric pouches
after Roux-en-Y gastric bypass
Dean Mikami Æ Bradley Needleman Æ
Vimal Narula Æ Janice Durant Æ W. Scott Melvin
Received: 14 December 2008 / Accepted: 1 May 2009
Ó Springer Science+Business Media, LLC 2009
Abstract EBWL), at 3 months (n = 15) was 6.7 kg (13.1% EBWL),
Introduction Weight gain after gastric bypass can occur at 6 months (n = 14) was 8.7 kg (17.0% EBWL), and at
in up to 10% of patients 5 years following and in about 1 year (n = 6) was 10.0 kg (19.5% EBWL). No major
20% of patients 10 years following surgery. The nadir complications were observed. The minor complications that
weight is usually reached within the first 2 years after were seen included a sore throat lasting less than 48 h in 34/
bypass surgery. However, weight may slowly be regained 39 patients (87.1%) and epigastric pain that lasted for a few
for numerous reasons. This phenomenon has been studied days in 30/39 patients (76.9%). Three patients with chronic
extensively, but there is often no one reason this occurs. diarrhea had their symptoms resolved after the procedure.
Once psychological and dietary reasons have been inves- Eight patients with gastroesophageal reflux disease reported
tigated, revisional surgery may be the only alternative for improvement in their symptoms post procedure.
treatment. Revisional gastric bypass surgery is associated Conclusions Endoluminal revision of gastric bypass
with a much higher morbidity and mortality when com- patients with weight gain using the StomaphyXTM proce-
pared with a primary gastric bypass procedure. dure may offer an alternative to open or laparoscopic re-
Patients and methods Thirty-nine patients underwent visional bariatric surgery.
endoluminal gastric pouch reduction with the Stoma-
phyXTM device after informed consent. The StomaphyXTM Keywords Endoluminal Á Bariatric Á Weight gain Á
device is a sterile, single-use device for use in endoluminal Revision Á Gastric bypass Á Gastric pouch reduction
transoral tissue approximation and ligation in the gastro-
intestinal (GI) tract.
Results Average age was 47.8 (29–64) years, and 36/39 A comprehensive approach to the bariatric patient, which
(92.3%) patients were female. Average body mass index includes a psychiatric, nutritional, medical, and surgical
(BMI) and weight prior to the StomaphyXTM procedure were evaluation, provides the best outcome. Gastric bypass sur-
39.8 (22.7–63.2) kg/m2 and 108.0 kg (65.90–172.2 kg). The gery remains the gold-standard operation worldwide for
average preprocedure excess body weight was 51.1 kg. weight loss. Many studies report excess percentage weight
Weight loss at 2 weeks (n = 39) was 3.8 kg (7.4% excess loss of 50–80% over a 24-month period [1, 2]. However,
body weight loss, EBWL), at 1 month (n = 34) was 5.4 kg failure of adequate weight loss and weight regain has been
(10.6% EBWL), at 2 months (n = 26) was 6.7 kg (13.1% reported to be as high as 25–30% after gastric bypass or
other bariatric procedures [3, 4]. Weight regain after bari-
atric procedures is usually multifactorial [5]. Psychological,
D. Mikami (&) Á B. Needleman Á V. Narula Á W. S. Melvin
The Ohio State University Medical Center for Minimally dietary, and medical follow-up are very important for long-
Invasive Surgery, N717 Doan Hall, 410 West 10th Avenue, term weight loss success. Once these factors have been
Columbus, OH 43210-1228, USA ruled out as the cause for weight regain, anatomical and
e-mail: dean.mikami@osumc.edu
surgical re-evaluation is warranted. The first diagnostic step
J. Durant should be an esophagogastroduodenoscopy (EGD) or upper
The Ohio State University Hospital, Columbus, OH, USA gastrointestinal (GI) study to evaluate for gastric-gastric
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2. Surg Endosc
fistula, gastric pouch dilatation or anastomotic dilatation. If
a gastric-gastric fistula is ruled out, the next step is to
determine if revisional surgery is an option. Once all
medical, psychological, and dietary efforts have been
exhausted, surgical revision may be the only alternative.
Recent studies quote a 5–13% rate of major complica-
tions with reoperative surgery for weight regain [6]. A
complete transoral method to treat weight regain could
potentially reduce or eliminate some of the most serious
postoperative complications such as anastomotic leaks,
wound dehiscences, incisional hernias, and pulmonary
Fig. 2 StomaphyX device end lumen with suction opening
complications. Some experts have hypothesized that
weight regain after bariatric surgery may be due to gas-
trojejunal anastomosis and/or pouch dilatation occurring study to evaluate their pouch anatomy. All patients were
over time. As a result, the patient may lose the feeling of required to undergo a session with our bariatric dietician to
early satiety and thus overeat. ensure a proper postoperative diet would be followed. All
In the setting of anastomosis dilatation, the afferent limb patients were instructed to be on a liquid diet for 2 weeks
of the alimentary Roux limb may act as a reservoir for food followed by six small meals after 2 weeks. Perioperative
along with the gastric pouch. This is evident in patients data was collected under an institutional review board
years after their bariatric surgery. Upper endoscopy may (IRB)-approved protocol. Postoperative assessment inclu-
reveal that the size of the stoma or anastomosis is some- ded length of hospital stay, weight loss at 2 weeks and 1, 2,
times greatly enlarged. It is not uncommon to see anasto- 3, 6, and 12 months, complications, and any other unex-
mosis twice their original diameter, which is typically 1.0– pected changes. The StomaphyXTM endoluminal fasteners
1.5 cm immediately postoperatively. and delivery system (EndoGastric Solutions, Redmond,
The pouch size is also sometimes greatly enlarged. It is WA) is US Food and Drug Administration (FDA) 510(k)
not uncommon to see pouches two to three times their indicated for use in transoral tissue approximation and
initial volume, which start off typically at 15–30 cc. The ligation in the GI tract (Figs. 1, 2, 3). The StomaphyXTM
goal of this study is to investigate if it is possible to restore endoluminal fastener system utilizes 7-mm, 3-0 polypro-
the stoma to its original inner diameter and/or the pouch to pylene H-fasteners to create full-thickness, serosal-to-
its original volume transorally by utilizing a new natural serosal tissue approximation (Fig. 4). We hypothesized
orifice surgical device called the StomaphyXTM. that, the more fasteners we placed during each procedure,
the better the long-term weight loss would be. Twelve to 41
(average 17) fasteners were placed during each of the
Patients and methods cases. All procedures were performed in the operating
room under general endotracheal anesthesia. A special
Thirty-nine patients underwent preoperative assessment, mouthpiece, which is supplied with the device, was used in
which included evaluation by a registered dietician and each case to allow the passage of the StomaphyX device
consultation with a bariatric surgeon. Selection criteria into the mouth and esophagus. An initial upper endoscopy
included patients that were at least 2 years from their ori- was done using a gastroscope with an 8.6 mm outer
ginal gastric bypass surgery and had gained at least 10% of diameter. The distance from the gastrojejunostomy anas-
their lowest nadir weight. All patients had a preoperative tomosis and the gastroesophageal junction to the mouth-
upper endoscopy or an upper gastrointestinal swallow piece was measured. The difference between the two
Fig. 1 StomaphyXTM
mechanism of tissue
approximation
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3. Surg Endosc
Fig. 3 StomaphyX device main
body
in a circular clockwise fashion with the first fastener placed
at the 6 o’clock position followed by five other fasteners.
The second level of fasteners was placed 1 cm proximal to
the first row. A total of 12 fasteners were placed at two
different levels (Figs. 7 and 8). Additional 3–5 fasteners
were then placed at any open mucosal area that could be
identified. Repeat endoscopy was then used at the end of
the procedure to assess the reduction of the gastric pouch
and anastomosis. All patients were seen at 2 weeks and at
1, 2, and 3 months to assess weight loss and to get a sub-
jective description of their postoperative feeling of satiety.
Phone interviews were conducted for patients who were
greater then 6 months out from the procedure.
Fig. 4 StomaphyX polypropylene fastener
Table 1 Demographics
Age (years) 47.8 (29–64)
Pre endoluminal procedure weight (kg) 108.0 (65.90–172.2)
BMI (kg/m2) 39.8 (22.7–63.2)
Height (inches) 64.3 (60–70)
Sex 92.3% female
Fig. 5 Pre StomaphyXTM anastomotic diameter
Average preprocedure EBW (kg) 51.1 (18.6–115.4)
measurements gave us the length of the gastric pouch. The
gastroscope was then placed through the internal lumen of
the StomaphyXTM device, and extended approximately
20 cm beyond the StomaphyXTM device. After adequate
lubrication, the gastroscope and the StomaphyXTM device
were passed through the mouthpiece and down the
esophagus as one unit. The next step was to intubate the
efferent jejunal limb to allow the passage of the Stoma-
phyXTM device through the anastomosis.
The StomaphyXTM device uses suction to draw tissue
through an opening near the distal end of the device. A
circular pleat of tissue is created 1 cm proximal to the
anastomosis (Figs. 5 and 6). This was completed by going Fig. 6 Post StomaphyXTM anastomotic diameter
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4. Surg Endosc
Table 2 Postoperative weight loss
Time Weight loss (kg) n
2 weeks 3.8 (1.2–17.7) 39
1 month 5.4 (1.3–18.6) 34
2 months 6.7 (2.3–22.2) 26
3 month 6.7 (2.7–22.7) 15
6 months 8.7 (2.3–25.4) 14
12 months 10.0 (2.3–29.5) 6
Table 3 Postoperative percentage excess body weight loss
Fig. 7 Pre StomaphyX gastric pouch
Time Excess body weight n
loss (%)
2 weeks 7.4 (2.5–13.0) 39
1 month 10.6 (3.0–21.2) 34
2 months 13.1 (4.0–28.0) 26
3 months 13.1 (4.1–30.9) 15
6 months 17.0 (4.2–36.0) 14
12 months 19.5 (5.7–38.0) 6
There were no major adverse events. Thirty-four of 39
(87.1%) patients experienced sore throats lasting less than
48 h. Thirty of 39 (76.9%) patients experienced epigastric
pain that lasted for a few days. Patient seven and eight were
Fig. 8 Post StomaphyX gastric pouch
discharged after a 23-h stay to due to their cases being
completed late in the afternoon. All 39 patients at their 2-
Results week visit described a feeling of increased early satiety.
There were 11 patients with unexpected results after the
All 39 patients were treated after informed consent for StomaphyXTM procedure. Three patients with late dumping
transoral tissue approximation and upper endoscopy by one syndrome after their original gastric bypass had their
surgeon. Thirty-seven patients were treated as outpatients postprandial diarrhea resolved. Eight patients with history
and two were kept overnight due to their cases being done of gastric esophageal reflux had their symptoms improve
late in the afternoon. All patients were sent home with an oral after the StomaphyXTM procedure at their 1-month visit
narcotic agent for approximately 1 week. Average age was (Table 3).
47.8 (29–64) years and 36/39 (92.3%) patients were female.
Average body mass index (BMI) and weight prior to the
StomaphyXTM procedure were 39.8 (22.7–63.2) kg/m2 and Discussion
108.0 kg (65.90–172.2 kg). Average preprocedure excess
body weight was 51.1 kg (Table 1). Average time of the It is estimated that 10–20% of patients who undergo gastric
procedures was 35 min (16–62 min). Between 12 and 41 H- bypass will regain some weight at 5–10 years. There is a
fasteners were used in each case. Weight loss at 2 weeks 12% incidence of surgical revisions after gastric bypass
(n = 39) was 3.8 kg (7.4% excess body weight loss, surgery [7]. In a review of the literature on reoperative
EBWL), at 1 month (n = 34) was 5.4 kg (10.6% EBWL), at open bariatric surgery, there were 17 papers with 838
2 months (n = 26) was 6.7 kg (13.1% EBWL), at 3 months patients, with a 14% major complication rate and 1.3%
(n = 15) was 6.7 kg (13.1% EBWL), at 6 months (n = 14) mortality rate [8]. Also in this review, there were 64
was 8.7 kg (17.0% EBWL), and at 1 year (n = 6) was patients in the laparoscopic revision group, with a 9%
10.0 kg (19.5% EBWL). Three of 15 (20%) and 1 of 14 major complication rate and 4.5-h average operating room
(7.1%) patients with follow-up at 3 and 6 months, respec- time. Khaitan performed 39 bariatric revisions from 1998
tively, lost less than 5% of their EBW (Table 2). to 2003. In Khaitan’s series, there was a 2.9% mortality
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5. Surg Endosc
rate, 24% of patients required a second operation after their
revision, and a 5-month change in BMI from 43.5 to
37.4 kg/m2 [9].
The mechanism of action of the StomaphyXTM device is
the approximation and immobilization of two or more
serosal surfaces through tissue fastening utilizing poly-
propylene H-fasteners. Limited and controlled localized
trauma through piercing with a needle or the fastener
potentially increases the stability of the apposed tissues
through fibrosis and increased fibroelastic tissue deposi-
tion. The fastener leads to a desired mild foreign-body
reaction with lymphocytes, macrophages, and sometimes
eosinophil cells in the tissues surrounding the fastener. The
end result of this reaction leads to further encapsulation, Fig. 9 Post StomaphyX gastroesophageal junction
fibrosis, and fibroelastic tissue deposition, further stabiliz-
ing the newly created bond [10].
At the same time, it is critically important to maintain a jejunum. This is thought to be one of the major mecha-
satisfactory perfusion of the apposed tissues in order to nisms of late dumping. These three patients continue to
prevent tissue ischemia and subsequent tissue death and enjoy a better quality of life along with their weight loss.
necrosis. Only with perfusion can apposed tissue form Eight patients had improvement of their gastroesopha-
adhesions and ultimately fuse [11]. geal reflux disease; this phenomenon has been seen with
The StomaphyXTM fastener configuration is made of an other plication devices [15]. Pleats of tissue that were
established and FDA-approved polypropylene. Polypropyl- plicated at or near the gastroesophageal junction with the
ene is widely used, from permanent surgical implants (in the StomaphyXTM device may have increased the lower
form of mesh to repair inguinal hernias) to sutures for all esophageal valve robustness (Fig. 9). Another theory
possible applications [12, 13]. Furthermore, polypropylene’s would be that diet is restricted by satiety, thus limiting the
characteristics and durability have been well established in amount of food that can overdistend the pouch and possibly
the past. One major advantage of the polypropylene H-fas- lead to reflux. This also further dissolves the theory that
tener is the fact that its breaking strength is increased through gastric stoma tightness increases gastric reflux symptoms.
loading and/or extension of the material [14]. Still, the longevity of the improvements these patients
Safety was our main concern in our group of patients experienced regarding their reflux remains unclear. Further
that underwent the StomaphyXTM procedure. No major studies are being considered with perioperative pH moni-
adverse events were seen, and weight loss was accom- toring and symptom scores.
plished in the short term. Data collection for these patients The take-home message to our patients undergoing the
is ongoing. StomaphyXTM procedure was that it is a tool for further
The cost-effectiveness of an endoluminal versus tradi- weight loss. The majority of the patients felt a greater
tional revisional gastric bypass procedure has yet to be feeling of satiety within the first few months. The patients
determined. It is fair to say that, if we can minimize the that were very successful used that feeling of early satiety
postprocedure complication rate associated with traditional and ate less. Once they lost some of their weight, they
revisional surgery, long-term cost may be lower in the began to exercise more, which jump-started more weight
endoluminal group. Still, we need to prove the longevity in loss. We are continuing to study the successes and failures
the endoluminal group to justify its cost. We saw a wide we have had in this series. The key will be to determine
range of weight loss in our series. At 3 months, we had two who will benefit most from an endoluminal procedure
patients losing 2 kg, while two others lost 11 kg and one versus a traditional gastric bypass revision.
lost 23 kg. The key component will be patient selection,
which is an important factor when undergoing any type of
weight loss operation. Conclusions
The unexpected, but positive, outcomes of the three
patients regarding the resolution of diarrhea were probably The StomaphyXTM procedure may offer an alternative to
multifactorial. The gastric-colic reflex was most likely open or laparoscopic revisional bariatric surgery. Initial
disrupted along with the slowing of previous rapid gastric trials with the StomaphyXTM device in the USA demon-
emptying. The slowing of rapid gastric emptying most strated minimal morbidity and no mortality. Long-term
likely reduces the rate of carbohydrate flow into the randomized prospective studies need to be carried out to
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validate the effectiveness, safety, and durability of the 7. Gagner M, Gentileschi P, de Csepel J et al (2002) Laparoscopic
StomaphyXTM procedure. reoperative bariatric surgery: experience from 27 consecutive
patients. Obes Surg 12:254–260
8. Jones KB (2005) Revisional surgery—potential safe and effec-
tive. SOARDS 599-603
9. Khaitan L, Van Sickle K, Gonzalez R et al (2005) Laparoscopic
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