Gastric leaks represent serious complications of bariatric surgery. With the increasing popularity and performance of bariatric procedures, the incidence of leaks and associated complications are expected to increase. Minimally invasive natural orifice surgery represents a novel and promising approach to gastric leak management, especially for morbidly obese patients who are at much higher risk from open or laparoscopic surgical procedures. The present article reports two cases of the safe and successful use of the EndoGastric Solutions StomaphyX™ device to alter the flow of gastric contents and repair gastric leaks resulting from bariatric revision surgery. Both patients were at a high risk and could not undergo another open or laparoscopic surgery to correct the leaks that were not healing. The StomaphyX procedures lasted approximately 30 min, were performed without any complications, and resulted in the resolution of the gastric leaks in both patients

AK Madan

AZ Fernandez

CC Thompson

HJ Sugerman

JC Gould

KA Elder

KD Higa

NT Nguyen

RW Schwartz

William T. Overcash

English

PubMed

Springer - Publisher Connector

CASE REPORT
Natural Orifice Surgery (NOS) Using StomaphyX™
for Repair of Gastric Leaks after Bariatric Revisions
William T. Overcash
Received: 8 December 2007 /Accepted: 23 January 2008 / Published online: 26 April 2008
# The Author(s) 2008
Abstract Gastric leaks represent serious complications of
bariatric surgery. With the increasing popularity and perfor-
mance of bariatric procedures, the incidence of leaks and
associated complications are expected to increase. Minimally
invasive natural orifice surgery represents a novel and
promising approach to gastric leak management, especially for
morbidly obese patients who are at much higher risk from open
or laparoscopic surgical procedures. The present article reports
two cases of the safe and successful use of the EndoGastric
Solutions StomaphyX™ device to alter the flow of gastric
contents and repair gastric leaks resulting from bariatric revision
surgery. Both patients were at a high risk and could not undergo
another open or laparoscopic surgery to correct the leaks that
were not healing. The StomaphyX procedures lasted approxi-
mately 30 min, were performed without any complications, and
resulted in the resolution of the gastric leaks in both patients.
Keywords RYGB . Revision . Complications . Bariatric .
Volume reduction
Introduction
The Roux-en-Y gastric bypass (RYGB) is the most commonly
performed bariatric procedure in the USA to treat morbid
obesity [1]. Numerous studies have documented the effec-
tiveness of RYGB in promoting excess body weight loss
typically in the 65–80% range after 1.5 to 2 years [1].
Despite the favorable short-term outcomes of this bariatric
surgical procedure, approximately 10–40% of patients do not
achieve successful long-term weight loss [2]. The weight
regain occurs typically within 2 to 7 years after RYGB
surgery and is associated with dilation of the pouch or stoma
[3, 4]. Several open and laparoscopic bariatric revision
procedures have been used in an attempt to correct these
dilations, but they all have been associated with serious
complications, such as perforations, obstruction, staple-line
disruption, blind loop syndrome, stomal ulcer, and incisional
hernias [2, 5, 6]. The most feared complication of gastric
surgery for morbid obesity, however, is a postoperative
gastric leak with the development of peritonitis [2, 5]. After
RYGB, leaks have been reported at the gastrojejunostomy,
the distal stomach, or the jejunojenuostomy in up to 5% of
all revision procedures with a significant morbidity and
mortality rate that may exceed 50% [7, 8].
StomaphyX™ (EndoGastric Solutions, Inc., Redmond,
WA, USA) is an incisionless transoral fastening device that
creates plications using polypropylene SerosaFuse™ fasten-
ers (Fig. 1). StomaphyX has been cleared by the US Food and
Drug Administration for tissue approximation and ligation
in the gastrointestinal (GI) tract. The device has been
successfully used for pouch and anastomosis volume reduc-
tion [9, 10]. The present study reports the results of two
patients who were treated with StomaphyX for management
of gastric leaks that developed after revisions of RYGB.
Case 1
A 58-year-old woman underwent a RYGB procedure at
another institution in 2003. The procedure was successful
and resulted in the creation of a 40-cc gastric pouch. The
patient completed counseling for eating disorders before
and after her original surgery. Unexpected events in her life,
OBES SURG (2008) 18:882–885
DOI 10.1007/s11695-008-9452-8
W. T. Overcash (*)
Bariatrics Munroe Regional Medical Center,
Suite 603, 150 S.E. 17th st, Ocala, FL 34471, USA
e-mail: woverc7507@aol.com
however, brought on depression, and she subsequently
returned to overeating, which resulted in dilation of the
gastric pouch to 600 cc and commensurate weight regain.
Once the patient regained control of her personal life and
her eating habits, she complained of a lack of satiety. An
open pouch reduction surgery was undertaken after exten-
sive discussions with the patient, counselors, and her family
members. The patient initially did well after the surgery, but
by day 12, she complained of increasing abdominal pain
and experienced fever of 38.9°C. Computer tomography
revealed a leak from the gastric pouch. The patient was
taken to the operating room and underwent debridement of
the staple line from the area of the initial surgery,
dehiscence on the gastric pouch (approximately 2 cm in
length), primary closure with drainage, and placement of a
feeding jejunostomy in the biliopancreatic limb. Despite an
initially successful procedure, a leak had redeveloped on
day 5 and required another sump drain to be placed. The
jejunostomy feeding tube was utilized, but there was
ongoing minute reflux of tube feeds, bile, and gastric
contents from the pouch recovered by the drains. The
output of the drains was more than 50 cc per hour when the
patient was on tube feeds and 20 cc per hour when total
parenteral nutrition (TPN) was used; therefore, TPN was
used to maintain the patient’s nutritional status. A positive
nitrogen balance was attained by an adequate caloric intake
and confirmed by a pre-albumin level greater than 14. The
drains were slowly backed out but resulted in no improve-
ment in the patient’s gastric leak. The patient remained
medically stable and afebrile.
An upper endoscopy was performed, and the leak was
found to be in a dependent position relative to the
gastrojejunostomy (Fig. 2), assuring that gastric contents
flowed preferentially through and placed pressure on the
leak. Removal of residual sutures was performed endo-
scopically, and the leak was estimated to be approximately
24F bougie in size (7.6 mm). The patient received
conservative therapy with maximal nutritional support, but
there was no progression in the healing of the leak for
4 months. Because of the patient’s condition, another open
revision surgery was considered to be of high risk.
As an alternative to an open or laparoscopic procedure,
the patient elected to undergo natural orifice surgery (NOS)
using the StomaphyX device. The patient was taken to the
operating room and placed under general anesthesia. An
upper endoscopy was performed to identify the anatomical
landmarks of the pouch and to locate the leak. The
endoscope was then inserted through the shaft of the
StomaphyX device (Fig. 1), and the device was introduced
through the patient’s mouth into the pouch under continu-
ous visualization. Once inside the pouch, vacuum was
employed to draw a large fold of tissue proximal to the leak
into the shaft of the device. The stylet of the device, which
is maintained entirely within the shaft at all times, was
advanced, and the first polypropylene fastener was
deployed across the base of the tissue fold creating a stable
full-thickness plication. Without removing the device from
the patient, another five plications were created circumfer-
entially at 1 cm from the leak. The plications on opposing
sides of the leak were then pulled together and fastened to
each other using the StomaphyX device in the same manner
that was used to create the first plications. Additional three
fasteners were deployed to create a bridge of tissue to shield
the leak. The device was removed, and a second upper
Fig. 2 Upper GI radiography showing leak inferior to the jejunum in
patient 1
Fig. 1 A general view (a) and the shaft part (b) of the StomaphyX
device
OBES SURG (2008) 18:882–885 883
gastrointestinal endoscopy was performed to evaluate the
results (Fig. 3). The duration of the procedure from inser-
tion of the devices to its withdrawal was 30 min. There
were no perioperative or postoperative complications. The
endoscopy revealed that the leak was reduced by at least
70%. The side of the pouch was also shortened to eliminate
the dependency of the leak relative to the gastrojejunos-
tomy. By pleating the pouch and including the leak, the
revised anatomy of the pouch formed a ridge of tissue that
changed the flow of gastric contents. This was document-
ed by a change in irrigation flow before and after the
StomaphyX procedure. At this time, the outflow from the
drains essentially stopped. The leak rapidly closed within a
few days, and all drains were removed. The patient was
released 4 days after the procedure and was instructed to
remain on a liquid diet, avoid strenuous physical activities
for the first 1 to 2 weeks, and advance progressively to a
regular diet and normal lifestyle activities over the follow-
ing 5 to 6 weeks. An endoscopy examination at 6 months
revealed the absence of a leak or fistula.
Case 2
A 42-year-old man desired a revision for weight regain
after an RYGB performed in 1997. Five years after the
original RYGB, a perforated stomach ulcer was diagnosed
and treated at another institution by closing the ulcer and
reconfiguring the small bowel. Ten years after the original
RYGB, the patient underwent additional revisional surgery.
A vertical sleeve and duodenal switch was performed. A
leak of about 1 cm in diameter developed immediately
along the staple line of the vertical sleeve within 5 cm from
the gastroesophageal junction (Fig. 4) and was accompa-
nied by symptomatology typical for a leak. The leak did not
close despite NPO and conservative therapy with maximal
nutritional support by tube feeds. The nutritional support
provided an adequate caloric intake and a positive nitrogen
balance, which was confirmed by a pre-albumin level
greater than 14. The patient remained stable, but there was
no improvement in the leak after 6 weeks despite the drains
being slowly backed out.
The patient underwent the NOS StomaphyX procedure
under general anesthesia following the protocol used for
patient 1. The procedure lasted 30 min and resulted in the
creation of six plications and a tissue shield over the leak. A
computer tomography scan performed the next day con-
firmed that the leak had been completely eliminated
(Fig. 5). No perioperative complications or postoperative
symptoms were reported. The patient was released 4 days
after the procedure and followed the same dietary and
Fig. 4 Upper GI radiography showing a horizontal leak from
duodenal switch near gastro-esophageal junction on the greater
curvature side of the stomach in patient 2
Fig. 5 Computer tomography scan on the day after the StomaphyX
procedure showing no evidence of leak in patient 2
Fig. 3 Upper GI radiography after the StomaphyX procedure
showing flow into the jejunum in patient 1
884 OBES SURG (2008) 18:882–885
physical activity regimens as described for patient 1.
Normal nutrition and lifestyle were resumed within 60 days.
An endoscopy examination at 3 months revealed the
absence of a leak or fistula.
Discussion
The two cases presented in this article demonstrated a
successful repair of gastric pouch leaks using the Stoma-
phyX device. In the first case, the StomaphyX procedure
resulted in reducing the leak by 70% and promoted its
healing by diverting the gastric content flow in such a way
that the leak was no longer dependent to the gastro-
jejunostomy. In the second case, the leak was not dependent
upon the gastrojejunostomy, and the StomaphyX device
was used to close the leak and create a shield of tissue that
allowed the leak to heal. The StomaphyX procedures were
fast and safe, as they lasted only 30 min and did not result
in any complications. Both patients were released in 4 days
after the procedure and were able to return to their normal
diet and lifestyle within 60 days.
The StomaphyX device made possible the repair of
gastric leaks in two patients who were not candidates for
the standard higher risk open or laparoscopic procedures.
The transoral StomaphyX device proved invaluable to these
patients. Transoral incisionless surgery using StomaphyX
eliminates the risk of incisional infection and incisional
herniation and reduces the risk of nosocomial infections. It
is expected that, with future modifications, StomaphyX will
allow handling of post-gastric bypass leaks, fistulas, per-
forated ulcers, and, possibly, other post-bariatric complica-
tions, which are expected to increase with the increasing
popularity and performance of bariatric procedures.
Acknowledgments Dr. Overcash has no commercial associations
with EndoGastric Solutions that might represent a conflict of interest
in relation to the submitted manuscript and did not receive any
financial support from the company for conducting or publishing the
two StomaphyX cases.
The author would like to thank Anna Gawlicka from EndoGastric
Solutions for providing professional assistance with preparation of the
final version of the manuscript and its submission.
Open Access This article is distributed under the terms of the
Creative Commons Attribution Noncommercial License which per-
mits any noncommercial use, distribution, and reproduction in any
medium, provided the original author(s) and source are credited.
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Natural Orifice Surgery (NOS) Using StomaphyX™ for Repair of Gastric Leaks after Bariatric Revisions

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http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2493599

Natural Orifice Surgery (NOS) Using StomaphyX™ for Repair of Gastric Leaks after Bariatric Revisions

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