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Surgery for Obesity and Related Diseases 14 (2018) 1587–1593
Original article
Laparoscopic vertical clip gastroplasty – quality of life
Patrick Noel
a , b
, Adrian Marius Nedelcu
b , ∗, Imane Eddbali
a
, Natan Zundel
c
a
Emirates Specialty Hospital, 267 Oud Metha Road, Dubai, United Arab Emirates
b
ELSAN, Clinique Saint Michel, Centre Chirurgical de l’Obesite, Toulon, France
c
Herbert Wertheim College of Medicine, Florida International University, Miami, Florida
Received 16 March 2018; received in revised form 8 July 2018; accepted 16 July 2018
Abstract Background: Over the last decade, several techniques have emerged and the bariatric trends
have changed. A new bariatric procedure that has been proposed is laparoscopic vertical clip
gastroplasty (LVCG), which mimics the principle of laparoscopic sleeve gastrectomy, but with a
completely reversible mechanism. The introduction of a new procedure in the bariatric armamen-
tarium necessitated a period of preclinical and clinical studies and a validation of the procedure
concerning the quality of life.
Setting: Private hospital, Dominican Republic.
Objectives: The purpose of this manuscript was to evaluate patient satisfaction, measured by
various questionnaires after LVC G .
Methods: From November 2012 to February 2017, 138 patients underwent LVCG and demo-
graphic data were collected prospectively. A total of 82 were evaluated for quality of life with a
minimum follow-up of 6 months after the procedure. The quality of life was also analyzed re-
garding the complications and resolution of different medical conditions included in the Bariatric
Analysis and Reporting Outcome System score.
Results: Eighty-five patients (73.9%) agreed to participate in the study and a total of 82 patients
completed the questionnaires at all points in time. Seventy-one patients were female, with an
average age of 34 (19–38). Mean body mass index before operation was 42.4 kg/m
2 and declined
significantly in both the first and second year postoperatively to 33.7 kg/m
2 (1-year follow-up)
in 65 patients and 34.3 kg/m
2 (2-year follow-up) in 37 patients. The results showed failure for
1.2% of patients and were fair for 6.1% of cases. Quality of life was assessed as good for 26
patients (31.8%), as very good for 39 patients (47.5%), and as excellent for 11 patients (13.4%).
Conclusions: LVCG represents a new bariatric procedure that mimics the principle of laparo-
scopic sleeve gastrectomy, but with a completely reversible mechanism. The procedure consists
of a nonadjustable clip that is vertically placed parallel to the lesser curvature. After > 3 years of
clinical use, the weight loss results seem to be encouraging and up to 92.7% of patients have an
improved quality of life. (Surg Obes Relat Dis 2018;14:1587–1593.) © 2018 American Society
for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
Keywords: Laparoscopic vertical clip gastroplasty; Reflux; Sleeve; Reversible
There is substantial evidence that surgery is the only
valid treatment for morbid obesity [1,2] . Over the last
decade, several techniques have emerged and bariatric
∗Correspondence: Adrian Marius Nedelcu, NEDELCU Clinique Saint
Michel – Avenue d’Orient, 83100 Toulon, France.
E-mail address: nedelcu.marius@gmail.com (A.M. Nedelcu).
trends have changed [3,4] . Presently, the most commonly
performed technique is laparoscopic sleeve gastrectomy
(LSG), after many years of laparoscopic Roux-en-Y gas-
tric bypass being considered the gold standard. This growth
can be explained by several advantages that LSG carries
over laparoscopic Roux-en-Y gastric bypass, including the
https://doi.org/10.1016/j.soard.2018.07.013
1550-7289/© 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
1588 Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593
Tab l e 1
Demographic data.
Demographics Before surgery
Age 34
Sex Male 14%
Females 86%
Average BMI 42.4 (31.5–54.2)
BMI = body mass index.
absence of most side effects of bypass procedures such as
dumping syndrome, marginal ulcers, malabsorption, small
bowel obstruction, and internal hernia, allowing it to of-
fer a better quality of life (QoL) compared with gastric
banding [5] .
One of the main concerns for long-term results after
LSG is gastroesophageal reflux disease (GERD). Accord-
ing to several reports [6,7] , substantially more patients
were taking proton pump inhibitors for GERD late after
the procedure than before it. The data in the literature for
this issue, however, vary vastly [8] . Nevertheless, an inci-
dence of 21.4% for de novo GERD reported by Himpens
et al. [6] , in line with other series [9] , is a reason for
concern regarding an irreversible procedure like LSG, es-
pecially given the increased risk of evolution into Barrett’s
esophagus [10,11] .
Recently, a new bariatric procedure has been proposed:
laparoscopic vertical clip gastroplasty (LVCG) [12] , which
mimics the principle of LSG, but with a completely re-
versible mechanism. The procedure consists of a nonad-
justable clip that is vertically placed parallel to the lesser
curvature. The introduction of a new procedure in the
bariatric armamentarium necessitated a period of preclini-
cal and clinical studies and validation of the procedure con-
cerning QoL. Consequently, the purpose of this manuscript
is to evaluate patient satisfaction, measured by various
questionnaires.
Methods
From November 2012 to February 2017, 138 patients
underwent LVCG , and demographic data were collected
prospectively. A total of 82 were evaluated for QoL with
a minimum follow-up of 6 months after the procedure. De-
mographic data are summarized in Table 1 . The interroga-
tion was conducted by an independent investigator (P.N.),
who collected the data that were further independently an-
alyzed by another author (M.N.).
The score of Moorehead-Ardelt questionnaire [13] is
summarized in Fig. 1 . The Bariatric Analysis and Re-
porting Outcome System (BAROS) is a unique scoring
method to evaluate, in a single page, the results after
bariatric surgery. Points are added or deducted accord-
ing to weight loss, improvements in co-morbidities, and
changes in QOL. Points are deducted for complications
and reoperations, before yielding a final score that classi-
fies outcomes in the following 5 categories: failure, fair,
good, very good, and excellent. Weight evolution was an-
alyzed in terms of percentage of excess body mass index
(BMI) loss, calculated as (initial BMI – current BMI) /
(initial BMI – 25) ×100. Weight regain was scored with
−1 point and different weight loss was scored as follows:
0% to 25% with 0 points; 25% to 50 % with 1 point; 50%
to 75% with 2 points; and > 75% with 3 points. The med-
ical co-morbidities were classified as follows: aggravated
(one point less), unchanged (0 points), improved (1 point),
1 major resolved (2 points), and > 1 morbidity resolved (3
points).
Surgical technique
The surgical technique of LVC G has been described and
published previously [12] . Briefly, the first step is to cre-
ate a small opening at the angle of His with an articulated
dissector, followed by a 3- to 4-cm window on the greater
curvature, directly inferior to the incisura angularis. The
articulated dissector is passed into the lesser sac to the left
of the left gastric vessels and articulated to 90 °, coming
out at the angle of His. The weight loss clip and its flex-
ible closing belt is then inserted through this window and
fixed to the stomach both anteriorly and posteriorly after
inserting a calibration tube similarly as with LSG. The clip
consists of a silicone-covered titanium backbone with an
inferior hinged opening that separates a medial lumen from
an excluded lateral gastric pouch. The inferior opening al-
lows the gastric juices to empty from the fundus and the
body of the stomach into the distal antrum ( Fig. 2 ). The
technique thus did not involve extensive dissection of the
hiatus.
Statistical analysis
The t test was used for the comparison of variation of
QoL score between the preoperative and postoperative test.
A t test’s statistical significance indicates whether the dif-
ference between 2 groups’ averages most likely reflects a
“real” difference in the population from which the groups
were sampled. The significance threshold was set for P <
.05.
Results
Between November 2012 and February 2017, 138 pa-
tients underwent LVCG . Upon consultation with the Eu-
ropean Union regulatory agencies, by protocol, 15 clips
were to be removed after different lengths of time of im-
plantation to prove reversibility. Eight other patients had
their clips removed for different complications that were
discussed in the previous report [12] . After clip removal,
Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593 1589
Fig. 1. Moorehead-Ardelt questionnaire.
these patients were not included statistically. Of the re-
maining, 85 patients (73.9%) agreed to participate in the
study and a total of 82 patients completed the question-
naires at all different points in time. Seventy-one patients
were female with an average age of 34 (19–38) years.
Mean BMI before operation was 42.4 kg/m
2 and declined
significantly in both the first and second year postopera-
tively to 33.7 kg/m
2 (1-year follow-up) in 65 patients and
34.3 kg/m
2 (2-year follow-up) in 37 patients.
The analysis of the Moorhead-Ardelt Quality of Life
Questionnaire showed a significant improvement of the
scores for each of 6 dimensions. The variation of the scores
of QoL is significant ( P < .001). For item 1 (“I usually
feel…”), the QoL was improved by 181%, for item 2 (“I
enjoy physical activities”) by 262%, for item 3 (“I have
satisfactory social contacts”) by 69%, for item 4 (“I am
able to work”) by 19%, for item 5 (“The pleasure I get
out of sex”) by 41%, for item 6 (“The way I approach
1590 Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593
Fig. 2. Laparoscopic vertical clip gastroplasty.
food is….”) by 418%. Each patient’s answers for each of
these 6 items are summarized in Figs. 3 and 4 .
The QoL was also analyzed regarding the complications
and resolution of different medical conditions included in
the BAROS Score. The results showed failure for 1.2% of
patients and were fair for 6.1% of cases. The QoL was
assessed as good for 26 patients (31.8%), as very good
for 39 patients (47.5%), and as excellent for 11 patients
(13.4%).
Discussion
The constant need to find a new bariatric operation rep-
resents a clear sign that all the current procedures have
certain limitations and complications. LSG became the
most common performed bariatric procedure probably be-
cause of its good ratio between complications and weight
loss results and its high popularity in social media. Still,
many surgeons implicate the LSG for 2 major disadvan-
tages: postoperative GERD and irreversibility. The LVC G
has the same restriction principle as LSG with a similar
gastric tube volume. It restricts oral intake with no need
of resection (requires no stapling), does not change gastric
anatomy (compared with LSG), causes no malabsorption
(compared with laparoscopic Roux-en-Y gastric bypass),
and does not require any adjustment (compared with la-
paroscopic adjustable gastric band [LAGB]).
Because reversibility is considered one of the main ad-
vantages of this new procedure (especially compared with
sleeve), particular attention was paid to the closing pres-
sure of the device during the preclinical studies.
The first gastric clip was developed in the 1980s without
any success, mainly because it was associated with com-
plications [14] . The rigidity of the device, its components,
and its oblique position at the upper part of the stomach
explained the high rate of obstruction and erosion at that
time. It was more an obstructive procedure than a restric-
tive one and was placed more like a nonadjustable gastric
band than a Bari Clip. Currently, the Bari Clip is designed
to minimize the closing force so that the limbs will sim-
ply oppose the anterior and posterior walls of the stom-
ach to minimize the possibility of erosions and ischemia.
The experience with the gastric band with the 2 different
techniques (pars flacida and perigastric) taught us a lesson
about gastric migration. Himpens et al. [15] reported a rate
up to 28% for band erosion with the perigastric technique.
Even if a further review [16] showed a decreased incidence
of band erosion with the modification to the pars flacida
Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593 1591
Fig. 3. Items evolution of Moorehead-Ardelt questionnaire.
technique, this complication remains one of the inconve-
niences of the LAGB.
Up to 4 years, with LCSG, erosion was seen in 2 pa-
tients (1.4%), both located at the antrum of the stomach.
This was diagnosed 24 and 48 months postoperatively in
asymptomatic patients after being identified during routine
endoscopic surveillance. This complication was explained
after reviewing the recorded video. The reason for this
complication in the first patient was due to both the use
of a first-generation 13-cm clip instead of a 14.5-cm clip
and trauma to the antrum during placement. The gastric
clip was removed laparoscopically without complications.
For the second patient erosion was explained by chronic
slippage of the clip, which we chose at the time to manage
conservatively. We have since decided to change the man-
agement of the potential asymptomatic chronic slippage by
explanting or repositioning the clip.
The postoperative QoL after bariatric surgery is thought
to depend on the quantity of weight loss, resolution of
co-morbid medical conditions, improved function in daily
activities, and the absence of postoperative complications.
No reference standard yet exists for the assessment of
bariatric postoperative QoL. BAROS, introduced by Oria
and Moorehead in 1998 [13] , is an established and recog-
nized tool for QoL evaluation in people with obesity [17] .
BAROS QoL survey (incorporating the Moorehead-Ardelt
quality of life questionnaire) is simpler and more widely
used. We believe the BAROS survey might oversimplify
QoL assessment. Bobowicz et al. [18] used BAROS to
evaluate LSG outcomes in 84 patients 5 years after surgery.
An overall very good result was achieved in 30% of pa-
tients, whereas no effects were reported by 13% of respon-
dents. Similar or even greater results were recorded with
LCSG. For up to 60% of 82 patients, the QoL post-LVCG
was assessed as very good or excellent and no effect was
recorded for 7.3% of respondents. In the significant ma-
jority of the remaining group, the QoL was assessed as
average, corresponding to the general standard. Ribaric et
al. [19] presented a 3-year follow-up health-related QoL
on BAROS of patients operated on in France using the
Swedish adjustable gastric band method. The results were
evaluated in the preoperative period and 1, 3, 6, 12, 18,
24, and 36 months after surgery. It was found that weight
loss resulted in improved QoL over the 3 years of ob-
servation. The overall BAROS score increased from 1.4
preoperatively to 3.6 (2.2, P < .001) after 3 years. In our
study, the BAROS score improved from 1.08 (SD ±.96)
preoperatively to 5.34 (SD ±1.70) after LVC G . Our study
showed an important variation of the scores of the dimen-
sions “The way I approach food is….” and “physical ac-
tivity”, with mean increases of 418% and 262%, respec-
tively. They are the most important variations. On the phys-
ical plan, weight loss facilitates movement by decreasing
the handicap caused by the patient’s weight and volume.
The resumption of normal physical activities is facilitated.
The dimension “I am able to work…” was not strongly
modified in postoperative period, the score being increased
by only 19%.
1592 Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593
Fig. 4. Quality of life items.
At the beginning of LSG, many surgeons were im-
pressed by the rapidity with which patients shifted toward
chosing LSG instead of LAGB, mainly due to the sig-
nificantly greater rates of vomiting in the LAGB groups
[5,20] . LCSG represents a new bariatric procedure with a
device implanted (more or less similar to LAGB), but our
results showed that the QoL results and vomiting episodes
(6.52%) are more similar to LSG. One of the limitations
of our study and of LVCG will be represented by the sur-
geon’s enthusiasm in offering a novel procedure that is
likely to influence some patients toward that procedure,
despite our best efforts (independent investigators) to pro-
vide impartial and evidence-based information. For this
reason, another multicenter prospective trial will start in
well-selected centers that subsequently will be involved in
the surgeons’ training for this new procedure ( Table 2 ).
Tab l e 2
Complications after LVC G.
Complication Rate Management
Slippage 6.52% (n = 9) 2 explanted, 2 revised,
5 treated conservatively
Erosion 1.44% (n = 2) Explanted
GERD 5% (n = 7) the first month
.72% (n = 1) after 1 mo
PPI
LVCG = laparoscopic vertical clip gastroplasty; GERD =
gastroesophageal reflux disease; PPI = proton pump inhibitors.
Postoperative gastroesophageal reflux
The lack of objective measurements such as pH-metry,
impedance, and high-resolution manometry does not pro-
vide robust evidence on the effects of LSG on GERD. The
Roux-en-Y gastric bypass represents the most common
Patrick Noel et al. / Surgery for Obesity and Related Diseases 14 (2018) 1587–1593 1593
option, especially for patients with severe gastroesophageal
reflux after LSG. Newer strategies like Stretta, Linx, or En-
dostim [21,22] need to be explored and could represent a
future alternative. To avoid GERD after LSG, a new pro-
cedure, N-sleeve [23] , was proposed, with the following
2 main limitations: incomplete gastric fundus removal and
difficult revisional procedures in case of weight regain or
recurrence of GERD. Compared with this, LVCG presents
complete exclusion of the gastric fundus. With its minimal
dissection of the hiatal region, a revisional procedure will
be less difficult, with decreased risk of complications.
Conclusion
LVCG represents a new bariatric procedure that mim-
ics the principle of LSG, but with a completely reversible
mechanism. The procedure consists of a nonadjustable clip
that is vertically placed parallel to the lesser curvature. Af-
ter > 3 years of clinical use, the weight loss results seem
to be encouraging, and up to 92.7% of patients report im-
proved QoL.
Disclosures
The authors have no commercial associations that might
be a conflict of interest in relation to this article .
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