Journal of Pediatric Surgery xxx (2016) xxxxxx

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Journal of Pediatric Surgery

journal homepage: www.elsevier.com/locate/jpedsurg

Laparoscopic fundoplication in neonates and young infants: Failure rate

and need for redo at a high-volume center
Pablo Laje , Thane A. Blinman, Michael L. Nance, William H. Peranteau
Division of General, Thoracic and Fetal Surgery, Children's Hospital of Philadelphia, USA

a r t i c l e i n f o a b s t r a c t

Article history: Aim of the study: Present the outcomes of patients younger than 2 years who underwent laparoscopic
Received 3 November 2016 fundoplication, highlighting the failure rate and need for redo fundoplication.
Accepted 8 November 2016 Methods: Retrospective review of patients b 2 years who underwent laparoscopic fundoplication between
Available online xxxx January 2009 and December 2014.
Main results: 458 infants younger than 2 years underwent laparoscopic fundoplication in the 6-year period (360
Key words:
Nissen, 77 Toupet and 21 Thal fundoplications). Median age at surgery was 5 (123) months. Median follow-up
Laparoscopic fundoplication
Redo fundoplication
was 3 (16) years. The conversion rate was 0.87% (4 of 458 cases). Patients did not undergo routine studies to
Infants assess the incidence of postoperative GER but were instead followed clinically. Failure of the fundoplication
Failure rate was determined when a patient was unable to gain weight and/or protect the airway while receiving gastric
feedings because of GER. The failure rate in our experience was 2.6% (12 redo out of 458 cases [11/360 Nissen,
1/77 Toupet and 0/21 Thal]). All failed cases occurred because of migration of the fundoplication, conrmed pre-
operatively by a contrast study. Median time between the initial fundoplication and the redo was 13 (527)
months. There were no failures within a contemporaneous group of 101 patients b 2 years who underwent
open fundoplication.
Conclusion: The need for a redo fundoplication after a laparoscopic fundoplication was an uncommon event in
our experience (12 of 458 cases). Our results contrast with published studies that report higher failure rates.
Case volume per surgeon may explain in part the dissimilar results among studies.
Level of evidence: III.
2016 Elsevier Inc. All rights reserved.

Few infants need fundoplication, but at the same time, it is one of the
most common procedures performed by pediatric surgeons in most
centers in the US [1]. This fact is mostly driven by the high incidence
of premature births leading to a combination of chronic lung disease
and immature antigastroesophageal reux mechanisms. While the
threshold to switch from medical to surgical treatment varies greatly
among different regions of the world, the surgical technique (both lap-
aroscopic and open) is relatively standardized, which should theoreti-
cally result in similar surgical outcomes across practices.
Despite decades of performance, controversies persist, in large part
perhaps as a result of the broad heterogeneity of patients who may
need it, the lack of a gold standard test predicting who might benet,
and broad variation in laparoscopic skill across the profession [26]. In
addition, while fundoplication is generally effective, it remains unclear
how long fundoplication remains effective, especially in infants prone
to rapid growth [710].
Corresponding author at: 34th St. & Civic Center Boulevard, Wood Building, 5th Floor,
Philadelphia, PA 19104, USA. Tel.: +1 215 590 5905.
E-mail address: laje@email.chop.edu (P. Laje).
The aim of this report is to present the outcomes of our patients,
highlighting the failure rate and need for redo fundoplication, and com-
pare them with published data from other reference centers.
1. Materials and methods
After obtaining institutional review board approval (IRB 16012,713),
we performed a retrospective chart review of all patients younger than
2 years of age who underwent laparoscopic or open fundoplication be-
tween January 2009 and December 2014 at the Children's Hospital of
Philadelphia. The review was initiated in January of 2015 to ensure a
minimum of 1 year of follow-up. Patients older than 2 years of age
were excluded from the study because they mostly constitute a popula-
tion of patients with cerebral palsy who differ in their pathophysiology
from premature infants with chronic lung disease, congenital cardiac
disease or other neonatal/perinatal conditions. Patients who were ini-
tially operated elsewhere were also excluded from the study. Values
are represented as the mean one standard deviation. Statistical
comparisons between groups were performed using the Student t-test
for 2 samples assuming unequal variance when data were normally dis-
tributed. For nonnormally distributed data, the KruskalWallis and

http://dx.doi.org/10.1016/j.jpedsurg.2016.11.019
0022-3468/ 2016 Elsevier Inc. All rights reserved.

Please cite this article as: Laje P, et al, Laparoscopic fundoplication in neonates and young infants: Failure rate and need for redo at a high-volume
center, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.11.019
2 P. Laje et al. / Journal of Pediatric Surgery xxx (2016) xxxxxx
MannWhitney U tests were used to identify differences between
means. P 0.05 was considered signicant.
1.1. Laparoscopic technique
A 4-trocar or a 5-trocar technique was used in all cases, according to
the surgeon's preference. In the 4-trocar technique, a percutaneous
transparietal stitch was placed in the upper abdomen as a sling to re-
tract the liver upwards. In the 5-trocar technique, a self-retaining liver
retractor was placed in the subxiphoid region to retract the liver (some-
times without a trocar). A 4-mm/30-degree scope was used in all cases.
A large orogastric tube was kept throughout the operation as an esoph-
ageal stent and removed at the end of the case. The esophagus was par-
tially dissected off the diaphragmatic attachments with electrocautery
to gain intraabdominal length, but without excessive dissection (except
when a hiatal hernia was present, in which case the entire esophageal
hiatus, hernia sac and esophagus were taken apart) [11,12]. The short
gastric vessels were divided with monopolar energy. The esophageal hi-
atus, if redundant, was tightened with 1 to 3 interrupted stitches of 20
nonreabsorbable braided material (Ethibond, Ethicon, NJ, USA). Flop-
py Nissen fundoplication was always built without excessive tension
using 3 or 4 stitches of nonreabsorbable braided material (Ethibond,
Ethicon, NJ, USA). The Toupet fundoplication was built as a 270-
degree posterior wrap using six 20 Ethibond sutures, each taking a
bite of esophagus and stomach, the top 2 of which anchoring the wrap
at the 10-o'clock and 2-o'clock positions on the crus. The Thal
fundoplication was built using several 20 Ethibond sutures, creating
rst an inner row of sutures taken between the esophagus and 1 cm dis-
tal to the GE junction on the anterior surface of the stomach, and then a
second row completing the 240-degree anterior wrap anchoring this
portion of the stomach approximately 2 cm from the GE junction up
to the esophagus and crus. Each stitch included a bite of esophagus
and crural muscle anchoring the sutures at the 4 o'clock, 2 o'clock, 11
o'clock, and then nally 8 o'clock around the crura in a horizontal
mattress fashion. In cases of a hiatal hernia, the entire esophagophrenic
unit was reconstructed with nonreabsorbable collar stitches around the
esophagus prior to building the fundoplication. The type of fundoplication
(Nissen, Toupet or Thal) was always decided by the operating surgeon
based on his/her preference and each patient's particular anatomy
(e.g. limited fundus, microgastria).
2. Results
A total of 458 infants younger than 2 years underwent laparoscopic
fundoplication at our hospital in the 6-year analyzed period ( 76/
year). The operations were: Nissen fundoplication (n = 360), Toupet
fundoplication (n = 77) and Thal fundoplication (n = 21). There
were no demographic differences among the three subgroups. Median
age at surgery was 5 (123) months. Median follow-up was 3 (16)
years. The conversion rate to open surgery was 0.87% (4 of 458 cases,
all Nissen fundoplications) (Table 1).
Patients were followed periodically in the outpatient clinic after hos-
pital discharge. Patients did not undergo invasive studies (24-h pH
monitoring or upper gastrointestinal [UGI] contrast study) to investi-
gate the incidence of postoperative GER but were instead followed clin-
ically. Failure of the laparoscopic fundoplication (and therefore need for
Table 1
Comparison between different types of laparoscopic fundoplication and between all laparoscopic fundoplications and all open fundoplications.
All laparoscopic fundoplications Nissen
Number 458 360
Age at surgery (mo.) 5 (123) 5 (123)
Converted to open 4 4
Follow-up (years) 3 (16) 3 (16)
Failed/redo 12 11
N/A: not applicable.
Please cite this article as: Laje P, et al, Laparoscopic fundoplication in neonates and young infants: Failure rate and need for redo at a high-volume
center, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.11.019
redo fundoplication) was diagnosed when a patient was unable to gain
weight and/or protect the airway (e.g. increased O2 requirement) be-
cause of clinically obvious postoperative GER while receiving gastric
feedings (i.e. feedings provided either PO or via gastrostomy appeared
in the mouth without the vomiting effort) that did not respond to post-
operative medical interventions. The overall failure rate in our experi-
ence was 2.6% (12 redo fundoplications out of 458 cases [11/360
Nissen, 1/77 Toupet and 0/21 Thal]). Patients with a suspected failed
laparoscopic fundoplication underwent a UGI to determine the anatom-
ical reason prior to the redo fundoplication (disrupted fundoplication,
migration of the fundoplication, and/or hiatal hernia). All failed cases
occurred because of upward migration of the fundoplication. Eleven
redo fundoplications were done laparoscopically and one was done by
laparotomy. Median time between the initial fundoplication and the
redo was 13 (527) months. There were no failures within a contempo-
raneous group of 101 patients younger than 2 years who underwent
open fundoplication (P = 0.77; 89 Nissen, 11 Toupet, and 1 Thal open
fundoplications) (Table 1).
3. Discussion
The management of severe gastroesophageal reux (GER) disease in
neonates and infants varies among different regions of the world. For in-
stance, in Europe and the United Kingdom, there is a tendency to rely on
the medical management for longer periods of time, whereas generally
across the United States, there is a low threshold to switch from medical
management to surgical management. This approach, together with an
increasing incidence of premature births leading to a combination of
chronic lung disease and immature antigastroesophageal reux
mechanisms, makes gastric fundoplication in infants a very common
procedure in the Unites States. Regardless of the differences in the
management of GER, the surgical outcomes should be similar across
practices around the world because the surgical technique, laparo-
scopic and open, is relatively well standardized.
The postoperative follow-up of patients who underwent fundoplication
also varies across practices. It is our practice not to perform any type of
invasive studies (e.g. pH probe, UGI) unless there are clear symptoms
suggestive of postoperative GER. In our opinion, performing routine
scheduled postoperative studies has no real value, since a normal result
is a one-time piece of information that is not helpful in predicting the
future, and an abnormal result in the absence of symptoms should not
prompt an intervention. In patients with clear symptoms of postopera-
tive GER suggestive of a failed fundoplication (constant effortless reux
of gastric feedings to the mouth), we obtain a UGI to determine the
anatomical reason for the failure (migration of the wrap and/or hiatal
hernia and/or disruption of the wrap) in preparation for the redo proce-
dure. If there are no anatomical abnormalities in the UGI (no mechan-
ical failure) but the patient persists with symptoms likely related to
GER, we initiate medical management. The medical management con-
sists of a variety of empirical interventions: changes in the feeding reg-
imen, changes in the formula, and administration of proton-pump
inhibitors, among others [17]. If these medical interventions provide
improvement, the patient is deemed to have mild postoperative GER
and no surgical intervention is made. This is our management strategy,
but we understand that patients with postoperative GER and a normal
Toupet Thal All open fundoplications
77 21 101
6 (123) 5 (223) 4 (117)
0 0 N/A
2.9 (16) 3.2 (16) 3 (16)
1 0 0 (P = 0.77)
 P. Laje et al. / Journal of Pediatric Surgery xxx (2016) xxxxxx
Table 2
Comparison between published reports of laparoscopic fundoplication in children, highlighting the rate of redo fundoplication.
Number of cases Cases per year
Rossi et al., 2016 [13] 151 19
Fyhn et al., 2015 [14] 44 6 48
Papandria et al., 2015 [15] 18 7 42
Kubiak et al., 2014 [16] 54 5 77
Laje et al., 2016 458 76
UGI may be managed differently across practices (although likely only
medically).
Evaluating the outcomes of patients who underwent fundoplication
is particularly difcult because of the heterogeneity of the population
that is subject to the procedure and the multiple comorbidities that
are frequently present in these patients. Therefore, the typical postoper-
ative parameters that are commonly used in surgical comparative stud-
ies are rarely applicable here. For instance, the length of postoperative
hospital stay is hardly ever dictated by the resolution of the GERD, but
rather by the respiratory and/or cardiac conditions (among others).
Similarly, the postoperative mortality is almost never related to the
presence of GERD, to the operation, or to the resolution of the GERD.
Even strictly surgical outcome parameters are unreliable measures.
For instance, the time to begin enteral feedings and the time to reach
full feedings after the fundoplication can be greatly inuenced by a va-
riety of issues (e.g. positive pressure respiratory support, poorly con-
trolled pain). The only postoperative outcome measure that should
not be inuenced by the patients' heterogeneity and comorbidities is
the need for a redo fundoplication. In other words, we believe that the
patient's individual condition should have no effect on the integrity of
the fundoplication, and the failure of a fundoplication because of disrup-
tion, migration of the wrap or hiatal hernia is merely the consequence of
a technical issue at the time of the operation. The management of pa-
tients with symptomatic postoperative GER and abnormal postopera-
tive UGI ndings (disruption of the wrap, migration of the wrap and/
or hiatal hernia) is generally a redo fundoplication (unless the surgical
risk is deemed too high). This is a standardized strategy that has mini-
mal variations among practices around the world.
Despite the standardization of the surgical technique, the failure rate
and need for redo fundoplication are strikingly heterogeneous in the
literature (Table 2). There is a paucity of conclusive data regarding the
patients' factors that could be associated with a higher rate of failed
fundoplication and need for redo (age at surgery, postoperative
retching or neurologic impairment has not been conclusively shown
to increase the risk). As we stated before, in our opinion, the failure of
a fundoplication is generally the consequence of technical issues at
the time of the operation. We believe that centers/surgeons that per-
form a high number of laparoscopic fundoplications per year have a
lower failure rate and need for redo fundoplication [18]. This was cer-
tainly the case in our own series. The 458 laparoscopic fundoplications
were done by nine attending surgeons, but the distribution of cases
was uneven. The majority of the referrals in our practice go to three of
the surgeons, who performed 80% of the cases (366/458; mean of 122
cases per surgeon [85, 138 and 143]; mean of 20 cases per surgeon
per year). In that subgroup of cases, there were 7 redo cases (1.9%).
The other 20% of the cases (92/458) were done by 6 surgeons who get
referrals sporadically (mean of 2.5 cases per surgeon per year). In
that subgroup, there were 5 redo cases (5.4%). While this difference is
not statistically signicant, it appears clear in our view that 7 failures out
of 366 cases are a much better outcome than 5 failures within 92 cases.
Please cite this article as: Laje P, et al, Laparoscopic fundoplication in neonates and young infants: Failure rate and need for redo at a high-volume
center, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.11.019
3
Follow-up (mo.) Median age of patients (mo.) Redo rate (%)
51 43 14
56 16
7 12
62 11
36 5 2.6
We also compared our series of laparoscopic fundoplications to our
own contemporary age-matched series of open fundoplications and
found no statistically signicant difference in the need for redo
fundoplication. This is an expected result, in our opinion, because the
laparoscopic operations follow the same principles than the open ones.
In conclusion, failure of a laparoscopic fundoplication requiring redo
fundoplication was a very uncommon event in our series. Open
fundoplication was not associated with better failure rates compared
to laparoscopic fundoplication. Our results contrast with published
studies that report much higher failure rates after laparoscopic
fundoplication. We believe that the case volume per surgeon may ex-
plain, at least in part, the dissimilar results among studies.
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