Background. Weight regain secondary to VBG pouch dilation is a typical referral for Bariatric surgeons. In this study we compare an endoluminal pouch reduction (Stomaphyx) to RYGB for revision. Methods. A retrospective review was completed for patients with a previous VBG presenting with weight regain between 2003-2010. Results. Thirty patients were identified for study 23 RYGB, 14 StomaphyX. Significant post procedure BMI loss was seen in each cohort (RYGB, 47.7 ± 7 kg/m 2 to 35 ± 7 kg/m 2 ; StomaphyX 43 ± 10 kg/m 2 to 40 ± 9 kg/m 2 , = 0.0007). Whereas nausea and headache were the only complications observed in StomaphyX patients, the RYGB group had a 43.5% complication rate and 1 mortality. Complications following RYGB include: incisional hernia (13%), anastomotic leak (8.7%), respiratory failure (8.7%), fistula (8.7%), and perforation (4.35%). The median length of stay following RYGB was 6 days compared to 1.5 ± 0.5 days following StomaphyX. Conclusion. This study suggests that while RYGB revision may achieve greater weight loss, the complication rates and severity is discouraging. StomaphyX may be a safe alternative. Further technical modifications of the device and longer follow-up may clarify the role of this approach

Akram Al-Jahdali

Daniel W Birch

Francesco Saverio Papadia

Johan Bolton

Richdeep S Gill

Shahzeer Karmali

Simon Byrns

Xinzhe Shi

CiteSeerX

Hindawi Publishing Corporation
Journal of Obesity
Volume 2013, Article ID 108507, 4 pages
http://dx.doi.org/10.1155/2013/108507
Clinical Study
Endoscopic Revision (StomaphyX) versus Formal Surgical
Revision (Gastric Bypass) for Failed Vertical Band Gastroplasty
Johan Bolton,1 Richdeep S. Gill,1 Akram Al-Jahdali,2 Simon Byrns,3 Xinzhe Shi,4
Daniel W. Birch,4 and Shahzeer Karmali4
1 Department of Surgery, University of Alberta, Edmonton, AB, Canada T6G 2B7
2Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada
3 Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada T6G 2B7
4Center for the Advancement of Minimally Invasive Surgery (CAMIS), Community Services Center, Royal Alexandra Hospital,
Room 405, 10240 Kingsway, Edmonton, AB, Canada T5H 3V9
Correspondence should be addressed to Shahzeer Karmali; shahzeer.karmali@albertahealthservices.ca
Received 30 September 2012; Revised 4 December 2012; Accepted 18 December 2012
Academic Editor: Francesco Saverio Papadia
Copyright © 2013 Johan Bolton et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background. Weight regain secondary to VBG pouch dilation is a typical referral for Bariatric surgeons. In this study we compare
an endoluminal pouch reduction (Stomaphyx) to RYGB for revision.Methods. A retrospective review was completed for patients
with a previous VBG presenting with weight regain between 2003–2010. Results. Thirty patients were identified for study 23 RYGB,
14 StomaphyX. Significant post procedure BMI loss was seen in each cohort (RYGB, 47.7 ± 7 kg/m2 to 35 ± 7 kg/m2; StomaphyX 43 ±
10 kg/m2 to 40± 9 kg/m2,𝑃 = 0.0007).Whereas nausea and headache were the only complications observed in StomaphyX patients,
the RYGB group had a 43.5% complication rate and 1 mortality. Complications following RYGB include: incisional hernia (13%),
anastomotic leak (8.7%), respiratory failure (8.7%), fistula (8.7%), and perforation (4.35%). The median length of stay following
RYGB was 6 days compared to 1.5 ± 0.5 days following StomaphyX. Conclusion. This study suggests that while RYGB revision
may achieve greater weight loss, the complication rates and severity is discouraging. StomaphyX may be a safe alternative. Further
technical modifications of the device and longer follow-up may clarify the role of this approach.
1. Introduction
According to the World Health Organization, there are over
500million obese individualsworldwide [1]. Bariatric surgery
has been shown to be an effective treatment strategy to pro-
duce marked weight loss in patients with moderate to severe
obesity (BMI > 35 kg/m2) [2]. Bariatric surgery includes
both primarily restrictive and malabsorptive procedures.
Specifically, vertical banded gastroplasty (VBG), a primarily
restrictive bariatric surgical procedure, was first described by
Mason in 1982 [3]. Despite initial optimism with VGB, long-
term results have been disappointing. According to Balsiger
et al., only 20% of patients maintained 50% excess weight loss
(EWL) at 10-year followup [4]. Weight regain following VBG
may be related to staple-line dehiscence and stomal pouch
dilation [5]. In addition, reoperation and revision of VBG are
needed in 20% to 30% of patients [4, 6].
Roux-en-Y gastric bypass (RYGB) remains the most
common revisional procedure following failed VGB. RYGB
had been shown to producemarkedweight loss as a revisional
procedure for previously failed restrictive bariatric surgical
procedures [7–9]. However, some studies have suggested
increased complication rates with revisional bariatric oper-
ations as high as 12% to 41% ([10] Schwartz RW, Obes
Surg 2002; [11]. Recently, an endoscopic treatment strat-
egy involving the StomaphyX device (Endogastric Solutions
Inc., Redmond, WA, USA) has been used to revise gas-
tric pouch dilatations. Endoscopic revision via the Stom-
aphyX has been reported in patients following VBG and
RYGB successfully [12, 13]. Our objective was to retro-
spectively compare weight loss and complication rates,
following revision of failed VGB with either the Stoma-
phyX device or formal surgical revision to RYGB at our
institution.
2 Journal of Obesity
2. Materials and Methods
A retrospective review was completed for all patients
with a previous VBG presenting to a comprehensive adult
weight management clinic (Weight Wise) with weight regain
between 2003 and 2010.Themultidisciplinary team atWeight
Wise including physicians, nurses, physiotherapy, and dieti-
cians assessed these patients. Patients with previous VGB that
presented with persistent weight gain despite conservative
measures and meeting the Canadian Guidelines for Surgical
Intervention were considered for revision by StomaphyX or
open conversion to RYGB [14]. VBG revision endoscopically
via the Stomaphyx device was performed as a part of a clinical
trial, with the results previously reported by Manouchehri et
al. [12].
2.1. StomaphyXRevision of VBG. StomaphyX is an endolumi-
nal device that has recently been developed as an alternative
to revisional surgery. A gastroscope is inserted through the
internal lumen of the device and full-thickness gastric tissue
is suctioned into the device allowing for the application of
a polypropylene fastener which if repeated circumferentially
creates a circular pleat thus downsizing the gastric pouch.
The StomaphyX device has since been used and studied at
our institution as a minimally invasive revisional option for
patients with failed VBG [12].
2.2. Preoperative Characteristics. Patient demographics were
collected retrospectively, including age, sex, and mean pre-
operative weight and body mass index (BMI) following the
initial VBG.
2.3. Outcomes. The primary outcomes of interest were com-
plication rates after revisional procedure weight loss. This
included perioperative and postoperative complications such
as anastomotic leakage, intra-abdominal abscess, dehiscence,
respiratory or cardiac complications, and incisional hernia.
Mortality was also recorded. Weight loss following bariatric
revisional surgery was recorded. Also, the operative time to
complete either VBG revision with StomaphyX or formal
conversion to RYGB was recorded, along with length of
hospital stay (LOS).
2.4. Statistical Analysis. Descriptive statistics were reported
as mean ± standard deviation. Comparison of pre- and
postbariatric procedure outcomes was performed using a
paired Student t-test. Statistical significance was defined as
𝑃 < 0.05.
3. Results
There were a total of thirty-seven patients from 2003 to 2010
that were included in the analysis. The preoperative charac-
teristics are detailed in Table 1. Twenty-three patients were
identified that had previously failed VBG and conversion
to RYGB. Fourteen patients were identified with previously
failed VBG and endoscopic revision via StomaphyX. The
preoperative BMI in the RYGB group was 47.7 ± 7 kg/m2
Table 1: Patient characteristics of failed VBG patients following
StomaphyX or RYGB (𝑁 = 37).
Characteristic StomaphyX (N = 14) RYGB (N = 23)
Age (years) 46.4 (6.7) 49.0 (8.0)
Sex (% female) 93 78
Preoperative weight (kg) 119.5 (25.9) 140.3 (32.1)
Preoperative BMI (kg/m2) 43.4 (9.7) 49.8 (8.4)
RYGB: Roux-en-Y gastric bypass; Standard Deviation indicated in brackets.
50
45
40
35
0
Bo
dy
 m
as
s i
nd
ex
 (k
g/
m
)
0 5 10 15 20 25 30
Time (months)
2
∗
∗ ∗
Figure 1: Change in body mass index (BMI) following formal
conversion of VBG to RYGB. ∗𝑃 < 0.05 versus preoperative body
mass index.
compared to 43 ± 10 kg/m2 in the StomaphyX group. As
seen in Figure 1, patients with previously failed VBG had a
significant decrease in BMI following RYGB (47.7 ± 7 kg/m2
to 35 ± 7 kg/m2 at 24-month followup, 𝑃 = 0.0007).
In patients following StomaphyX endoscopic revision, there
was also a significant decrease in BMI (43 ± 10 kg/m2 to
40 ± 9 kg/m2 at 6-month followup, 𝑃 = 0.0007). Figure 2
demonstrates the changes in BMI in both groups at 6-months
followup.
The only complications observed in the StomaphyX
group were short-term nausea and headache (Table 2). On
the other hand, the RYGB group had an overall 43.5%
complication rate with a postoperative mortality. Major
complications in the RYGB group include anastomotic leak
(8.7%), incisional hernia (13%), fistula (8.7%), respiratory
failure (8.7%), and perforation (4.4%). The median LOS
following RYGB was six days compared to 1.5 ± 0.5 days
following StomaphyX endoscopic revision.
4. Discussion
This study retrospectively compares the use of two distinct
treatment strategies in patients with failed VBG at a single
institution. Formal conversion of the VBG to a RYGB inmor-
bidly obese patients results in marked weight loss, however,
with considerable morbidity. On the other hand, endoscopic
revision with the StomaphyX device in morbidly obese
patient produced less weight loss, with minimal morbidity.
Journal of Obesity 3
45
30
15
0
Bo
dy
 m
as
s i
nd
ex
 (k
g/
)
RYGB StomaphyX RYGB StomaphyX
Preoperative 6-month followup
m
2
∗ ∗
Figure 2: Comparison of initial body mass index and at 6-month
followup in VBG patients revised by RYBG or endoscopically
(StomaphyX). ∗𝑃 < 0.05 versus preoperative body mass index.
Table 2: Complications following VBG revision by either Stoma-
phyX or RYGB.
Type of complication StomaphyX (N = 14) RYGB (N = 23)
Death 0 1
Anastomotic leakage N/A 2
Fistula 0 2
Wound infection/abscess N/A 3
Cardiopulmonary failure 0 2
Minor complications 4∗ 6
Total 4 16
N/A: not applicable. ∗Short-term nausea and headache.
Similar to our findings, Gagné et al. reported that 38%
of patients converted to RYGB had either early or late
complications, including anastomotic leak, abscess, stricture,
bleeding, and respiratory failure. Other studies have also
suggested increased complication rates ranging from 12%
to 41%, following revisional surgery in previously failed
restrictive bariatric procedures [10, 11].
Endoscopic revision of failed VBG via StomaphyX device
is a novel treatment strategy. Endoscopic treatment avoids
the need for operative revision and related intra-abdominal
complications, such as anastomotic leakage. Two common
reasons for VBG failure are enlargement of the gastric pouch
and staple line dehiscence [14].The StomaphyX device is used
to decrease the size of the gastric pouch by approximating
and immobilizing two or more serosal surfaces through
tissue fastening [13]. Mikami et al. reported successful use
of the StomaphyX device in 39 patients to reduce the size
of the gastric pouch following RYGB [13]. These authors
reported a 10 kg weight loss at one-year followup with no
major complications and no mortalities. Leitman et al. also
reported a 7.3 kg weight loss at one-year followup and no
major complications, following endoscopic revision with the
StomaphyX device [15].
The twomain limitations of our study are duration of fol-
lowup and a small sample size.There are also other potentially
viable options such as revisionwith an adjustable gastric band
that were not included. With these major limitations its not
possible to make any definitive recommendations about the
use of StomaphyX. It does, however, present an interesting
debate about the relative importance of less complications
versus more weight loss.
5. Conclusion
In conclusion, endoscopic revision via the StomaphyX device
is a safe revisional treatment strategy in morbidly obese
patients that have failed VBG. In addition, endoscopic revi-
sion may be a reasonable initial approach to failed VBG, with
low complication rates. Further studies are needed to clarify
the role of the StomaphyX pouch reduction in patients with
failed VBG.
Authors’ Contributin
J. Bolton andR. S. Gill both serve as first authors of this paper.
References
[1] WHO, “Obesity and overweight,” Fact Sheet 311, 2011.
[2] R. Padwal, S. Klarenbach, N. Wiebe et al., “Bariatric surgery:
a systematic review and network meta-analysis of randomized
trials,” Obesity Reviews, vol. 12, no. 8, pp. 602–621, 2011.
[3] E. E. Mason, “Vertical banded gastroplasty for obesity,”Archives
of Surgery, vol. 117, no. 5, pp. 701–706, 1982.
[4] B. M. Balsiger, J. L. Poggio, J. Mai, K. A. Kelly, and M. G. Sarr,
“Ten and more years after vertical banded gastroplasty as pri-
mary operation for morbid obesity,” Journal of Gastrointestinal
Surgery, vol. 4, no. 6, pp. 598–605, 2000.
[5] E. E. Mason and J. J. Cullen, “Management of complications in
vertical banded gastroplasty,” Current Surgery, vol. 60, no. 1, pp.
33–37, 2003.
[6] D. A. del Amo, M. M. Dı́ez, M. E. Guedea, and V. A. Diago,
“Vertical banded gastroplasty: is it a durable operation for
morbid obesity?” Obesity Surgery, vol. 14, no. 4, pp. 536–538,
2004.
[7] H. J. Sugerman, J. M. Kellum Jr., E. J. DeMaria, and H. D.
Reines, “Conversion of failed or complicated vertical banded
gastroplasty to gastric bypass in morbid obesity,” American
Journal of Surgery, vol. 171, no. 2, pp. 263–269, 1996.
[8] J. Hedberg, S. Gustavsson, andM. Sundom, “Long-term follow-
up in patients undergoing open gastric bypass as a revisional
operation for previous failed restrictive procedures,” Surgery for
Obesity and Related Diseases, vol. 8, no. 6, pp. 696–701, 2012.
[9] D. J. Gagné, E. Dovec, and J. E. Urbandt, “Laparoscopic revision
of vertical banded gastroplasty to Roux-en-Y gastric bypass:
outcomes of 105 patients,” Surgery for Obesity and Related
Diseases, vol. 7, no. 4, pp. 493–499, 2011.
[10] R. W. Schwartz, W. E. Strodel, W. S. Simpson, and W. O.
Griffen, “Gastric bypass revision: lessons learned from 920
cases,” Surgery, vol. 104, no. 4, pp. 806–812, 1988.
[11] J. de Csepel, R. Nahouraii, and M. Gagner, “Laparoscopic
gastric bypass as a reoperative bariatric surgery for failed open
restrictive procedures: initial experience in seven patients,”
Surgical Endoscopy, vol. 15, no. 4, pp. 393–397, 2001.
4 Journal of Obesity
[12] N. Manouchehri, D. Birch, C. Menzes, X. Shi, and S. Karmali,
“Natural orifice surgery: endoluminal pouch reduction follow-
ing failed vertical banded gastroplasy,” Obesity Surgery, vol. 21,
no. 11, pp. 1787–1791, 2011.
[13] D. Mikami, B. Needleman, V. Narula, J. Durant, and W. S.
Melvin, “Natural orifice surgery: initial US experience utilizing
the StomaphyX TM device to reduce gastric pouches after
Roux-en-Y gastric bypass,” Surgical Endoscopy and Other Inter-
ventional Techniques, vol. 24, no. 1, pp. 223–228, 2010.
[14] D. C. Lau, J. D. Douketis, K. M. Morrison, I. M. Hramiak, A. M.
Sharma, and E. Ur, “2006 Canadian clinical practice guidelines
on the management and prevention of obesity in adults and
children,” Canadian Medical Association Journal, vol. 176, no. 8,
pp. S1–S13, 2007.
[15] I. M. Leitman, C. S. Virk, D. V. Avgerinos et al., “Early results
of trans-oral endoscopic plication and revision of the gastric
pouch and stoma following Roux-en-Y gastric bypass surgery,”
Journal of the Society of Laparoendoscopic Surgeons, vol. 14, no.
2, pp. 217–220, 2010.
Submit your manuscripts at
http://www.hindawi.com
Stem Cells
International
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
MEDIATORS
INFLAMMATION
of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Behavioural 
Neurology
Endocrinology
International Journal of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Disease Markers
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
BioMed 
Research International
Oncology
Journal of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Oxidative Medicine and 
Cellular Longevity
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
PPAR Research
The Scientific 
World Journal
Hindawi Publishing Corporation 
http://www.hindawi.com Volume 2014
Immunology Research
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Journal of
Obesity
Journal of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
 Computational and  
Mathematical Methods 
in Medicine
Ophthalmology
Journal of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Diabetes Research
Journal of
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Research and Treatment
AIDS
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Gastroenterology 
Research and Practice
Hindawi Publishing Corporation
http://www.hindawi.com Volume 2014
Parkinson’s 
Disease
Evidence-Based 
Complementary and 
Alternative Medicine
Volume 2014
Hindawi Publishing Corporation
http://www.hindawi.com


Clinical Study Endoscopic Revision (StomaphyX) versus Formal Surgical Revision (Gastric Bypass) for Failed Vertical Band Gastroplasty

http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=69E6F7843B154715FE6A1ED4A1AE6CDD?doi=10.1.1.1079.2963&rep=rep1&type=pdf

Clinical Study Endoscopic Revision (StomaphyX) versus Formal Surgical Revision (Gastric Bypass) for Failed Vertical Band Gastroplasty

Abstract

Similar works

Full text

Available Versions

CiteSeerX