Case Study
Current Status of the Robotic Fundoplication: Case Series and Literature Review
Juan Roberto González-Santamaría, María Rubí Valderrama-Gutiérrez, Erick Hiram Rubio Arroyo and Gustavo Alain Flores-Rangel*
Department of Robotic Surgery and Minimal Invasion, Zumpango High Specialty Regional Hospital, Mexico
*Corresponding author: Gustavo Alain Flores Rangel, Department of Robotic Surgery and Minimal Invasion, Zumpango High Specialty Regional Hospital, Zumpango-Jilotzingo highway Number 400, Barrio Santiago, Segunda Sección, Zumpango, 55600, Mexico
Published: 26 Sep, 2018
Cite this article as: González-Santamaría JR, Valderrama-
Gutiérrez MR, Rubio Arroyo EH, Flores-
Rangel GA. Current Status of the
Robotic Fundoplication: Case Series
and Literature Review. Ann Clin Case
Rep. 2018; 3: 1548.
Abstract
Introduction: For many years, open fundoplication was the standard for the surgical management
of Gastroesophageal Reflux Disease (GERD). In the last two decades, laparoscopic surgery has
displaced the open approach by achieving similar results, with a faster convalescence and less
postoperative pain. Robotic technology was recently introduced as an evolution of the conventional
laparoscopic, whose role is still to be validated.
Material and Methods: We describe a retrospective analysis of the initial experience in Nissen
floppy-type fundoplication performed by a robot assisted approach in the Zumpango's High
Specialty Regional Hospital.
Results: A total of 18 cases were found from June 2014 to December 2017. The total surgical time
was 146 minutes (120 min to 203 min), docking time 10.2 minutes (5 min to 20 min) and console
time 108.2 minutes (60 min to 153 min). The hospital stay was 39.4 hrs (18 hr to 192 hr), the
perioperative morbidity 11.1%, conversion 5.5%, reoperations 5.5% and death 0%. At 19.4 months
of follow-up, 84.6% presented remission or improvement of the initial symptoms of GERD (Visick
I, II), 15.4% reported no changes (Visick III), and no patient reported increased symptoms (Visick
IV). The morbidity and conversion of the first 9 cases was 22.2% and 11.1% respectively, while in the
following 9 cases it was 0% and 0%.
Discussion: Our initial experience with robot-assisted fundoplication shows comparable results
with the reported standards in the medical literature for any approach. The probability of conversion
and the incidence of complications are inversely proportional to the accumulated experience, due to
the robotic approach requires an aggregate learning curve.
Keywords: Reflux; Gastroesophageal; GERD; Robotic; Fundoplication
Introduction
GERD is defined as a condition that result from abnormal and recurrent exposition of
the esophagus and/or the respiratory tract to gastric contents which generates symptoms or
complications, among which are included esophagitis, peptic stenosis, Barrett's esophagus and a
diverse number of conditions in the respiratory tract [1,2]. It´s estimated that in the USA 44% of
the population shows symptoms of pyrosis once per month, 7% experience it daily, and 20% of
esophagitis is complicated [3].
The management is initially pharmacological in all cases, based on Proton-Pump Inhibitors
(PPI), H2 antagonist or anti acids. In relation to tolerance, effectiveness, costs and individual
characteristics of each patient, eventually it can be considered a surgical approach, which consists
on the making of a gastric plication and represents the therapeutical option with the best long term
results and with a higher satisfaction for the patient [2,4-6].
In 1956 Dr Rudolph Nissen published his procedure designate "fundoplication" [3], later named
Nissen fundoplication, which soon would become the standard surgical procedure for the GERD;
later Dallemagne et al. [7] performed the first fundoplication by a laparoscopic approach with
functional similar results to open surgery, but with a faster convalescence and less post-surgery
pain displacing this way the open approach [6,8]. Nevertheless, the laparoscopic manipulation is
hindered by the use of rigid not articulated instruments and a two-dimensional image, besides;
the physiological tremors of the surgeon are easily transmitted to the surgical field, which makes
dissections and delicate sutures difficult.
Facing this limitations, robotic technology has recently introduced
in the clinical laparoscopic practice with the objective of improving
surgical performance by eliminating tremors and fatigue, offering
a ergonomical pose to the surgeon, allow a tri-dimensional view of
the surgery field, granting optic control to the surgeon overcoming
the need to coordinate with an assistant, significantly improving
the approaching of stitch in complicated places and allowing better
maneuverability of the instruments [6].
The performance of robotic assisted fundoplications has proved
to be a feasible and safe alternative [9,10], with long term results
comparable to conventional laparoscopy [6,8,11], although the high
cost and surgical time for docking are a challenge for this technology.
Figure 1
Materials and Methods
This is a series of cases that aims to report the initial experience of
fundoplications performed by robot-assisted laparoscopic approach
in the Zumpango's Regional Hospital of High Specialty and compare
the results with those reported in the medical literature.
We retrospectively analyzed the files of all patients undergoing
any robot-assisted fundoplication since the acquisition of the robotic
surgical system (Da Vinci Si), in a period of time between January
2014 and December 2017. 3 surgeons participated in the performance
of the surgeries. The diagnosis of GERD was based on the criteria
proposed by the Society of Gastrointestinal and Endoscopic Surgeons
of the United States "SAGES" [1].
In all patients with clinical suspicion of GERD a high endoscopy
was performed, in case of erosive esophagitis, the diagnosis was
concluded without another diagnostic approach. In cases with high
clinical suspicion but negative endoscopy, atypical clinical symptoms
(dysphagia, odynophagia, weight loss and respiratory conditions) or
diagnostic doubt with esophageal motor disorder, pH-metrics and
manometry were performed.
The indications for antireflux surgery were patients with good
response to management with PPI but reoccurrence of symptoms
upon discontinuation, complications of GERD (Barrett's esophagus
or peptic stenosis), extra esophageal manifestations of the disease,
adequate control of the disease with pharmacological therapy but
increased dose or progression of the disease, and some patients with
poor response to PPI, particularly those with severe uncontrolled
regurgitation or with respiratory symptoms.
In all cases, a Nissen Floppy fundoplication was performed.
With general anesthesia, the patient in the supine position, the
pneumoperitoneum was performed through an optiview trocar of 12
mm in the umbilical scar, where the robotic arm of the camera was
introduced. It changes to position in Trendelenburg inverted at 30°,
trocars are placed under direct vision for two robotic arms of 10 mm
(right and left), one of 5 mm subxiphoid laparoscopic conventional
where Nathanson separator is inserted, and one of 5 mm in the left
(conventional laparoscopic) for retraction, aspiration, irrigation,
insertion and extraction of materials. The docking of the da Vinci
surgical system was cephalic as shown in Figure 1.
Circumferential dissection of the esophagus was performed, short
vessels were sectioned with monopolar energy and closure of the
diaphragmatic pillars with two or three simple polyester 2-0 stitch,
a 3 cm fundoplication was made without tension fixed with three
simple knots with the same suture and the intermediate anchored to
the anterior esophageal wall. Finally the robotic system moves away,
materials are removed by laparoscopy and the wounds are sutured.
Three times were recorded: the total surgical time, the robotic
docking, and the console time. Prophylactic antibiotic was
administered with a single dose 30 minutes before the first incision
and mechanical/pharmacological antithrombotic measures according
to the Caprini scale. After the surgical procedure, a liquid diet was
indicated in the first 4 hours with progression according to the
patient's tolerance. Conditions for discharge were normal vital signs,
tolerance to diet, controlled pain and no evidence of complications.
Long-term follow-up was carried out through telephone surveys
using the Visick scale for symptom control and EAT-10 for dysphagia
assessment.
Table 1
Results
A total of 18 cases were found. The average age was 44.7 years
(29 yr to 71 yr), 10 patients (55.5%) were female and 8 (45.5%) male.
77.7% of the patients presented esophagitis, being type B in the
majority of cases, while 22.2% (n=4) corresponded to non-erosive
GERD. 22.2% patients (n=4) presented hiatal hernia (Table 1).
The total surgical time was 146 minutes (120 min to 203 min),
10.2 minutes of docking time (5 min to 20 min) and 108.2 minutes
(60 min to 153 min) of console time. The hospital stay was 39.4 hrs
(18 hr to 192 hr), corresponding to 1.6 days on average.
The perioperative morbidity was 11.1% (2 patients), in one case
there was high digestive tract bleeding with spontaneous remission
that required transfusion of 2 erythrocyte concentrates, and the second case required conversion to open surgery (5.5% total incidence
of conversion) due to liver injury by the Nathansson separator,
with hepatic packing and subsequent reoperation for removal the
compresses 48 hours later. They corresponded to a cases number
3 and 6 respectively. If the above is analyzed in 2 periods of time,
morbidity and conversion rate in the first 9 cases was 22.2%/11.1%
respectively, and 0%/0% for the last 9 cases.
For the follow-up, the Visick and EAT-10 scales were applied,
which were achieved in 13 patients (72.2%) at 19.4 months on average
after surgery. 4 patients (22.2%) were not located, and 1 patient (5.5%)
refused to answer the survey. Of the patients interviewed, 84.6%
(n=11) presented remission or improvement of the initial symptoms
of GERD, while 15.4% (n=2) did not report differences (Table 2). On
the other hand, the incidence of dysphagia was 7.7% (Table 3).
Table 2
Discussion
For many years open fundoplication was the standard treatment
of gastroesophageal reflux showing good results, been displaced at
present by minimally invasive approaches. When a fundoplication is
compared by open vs. laparoscopic approach assisted by robot, the
superiority of the latter is not in doubts; an analysis carried out by the
"university consortium of health systems" who evaluated a database of
12,079 patients undergoing fundoplication secondary to GERD [12],
concluded that robot-assisted fundoplication was related to a lower
postoperative morbidity (5.6% vs. 11%), hospital stay (6.1 days vs. 3
days) and costs of care, although the sample of patients undergoing
robotic surgery only includes 339 patients.
When laparoscopic approach vs. assisted by robot are contrasted,
most published series agree that robotic surgery usually consumes
more surgical time [6,13-16], with total times of 86 min to 173 min
for conventional laparoscopic, and 137 min to 222 min for robotic
surgery [17], being maybe due to the time of docking, which has been
reported from 5.3 min to 23 minutes [15,17]. However, this result has
been inconstant on the experience of different authors, as the metaanalyzes
of Yao et al. [18] and Cundy et al. [19] conclude, where no
significant difference was found between the two approaches, or even
some authors have achieved a shorter surgical time with the robotic
system compared to the conventional laparoscopic, as reported by
Müller et al. [20] in a randomized clinical trial (88 min vs. 102 min,
p=0.03).
The truth is that the majority of robot-assisted fundoplication
reports have emerged from the initial cases, and it is expected that
as the experience increases, surgical time will be reduced [6], as
demonstrated by Heemskerk et al. [8] in a series of 11 patients where
in the first 5 cases the time interval between conventional and robotassisted
laparoscopy was 72 minutes in favor of the first, reducing
to 27 minutes in the following 6 cases. In another study where the
surgical times were analyzed over 2 years and 39 cases [17], it was
concluded that as a greater learning curve is reached, both the docking
time and the total surgical time are progressively reduced.
Although no study has been designed to specifically evaluate these
learning curves, a decrease of 61% of the surgical time is estimated
after the first 5 cases [21].
In the present series of cases, the total surgical time was 146
minutes, despite being an initial casuistry; the results were comparable
with the averages reported in the literature for both laparoscopic and
robotic surgery.
On the other hand, the average hospital stay is similar regardless
of the approach, but widely variable depending on the author's
preferences, with a range of 18 hrs (0.75 days) to 105.6 hrs (4.4 days)
[12-20,22]. In the present series, the average hospital stay was 39.4
hrs (1.6 days), with a stay in census beds of one night in 89% of cases.
Some reports of initial experiences have concluded a greater need
for conversion in patients with a robot-assisted approach, in figures as
high as 11.4% [15], however, in systematic reviews and meta-analysis
where more experienced series are included, there is no difference
in the need for conversion between a robotic or laparoscopic
approach, being generally less than 3% [16,18]. We found the need
for conversion on an occasion (5.5%), corresponding to case number
3, due to a liver injury whit bleeding caused by the hepatic retractor.
On the other hand, when it comes to redo fundoplication, robotic
surgery assistance has shown superiority, with lower incidence of
conversions to open surgery and shorter hospital stay [16,23].
Perioperative morbidity in general has been reported from 0% to
5.6% [12,17,24]. In 3 meta-analyzes on the adult population [6,14,18]
and 1 on pediatrics [19], general morbidity was reported without
significant difference between conventional or robotic laparoscopic
approach [6,14,16,18]. The general probability of reoperations is
equivalent [6,14,16,18], requiring in 5.1% of the cases and dysphagia
being the main cause followed by the recurrence of reflux symptoms
[12,17].
Our experience in the first 9 cases was with a high rate of morbidity
(22.2%) and conversion (11.1%), while in the following 9 cases there
was no case, concluding that there is an initial learning curve that
must be overcome. It is logical to think that this learning curve must
be overcome for any approach, be it open, laparoscopic or robotic.
Most published series conclude that robotic surgery involves
a higher cost [12-14,16,19,20], although not all authors agree with
this statement, such as the meta-analyzes performed by Wang
et al. [6] and Yao et al. [18] that included only prospective cohort
studies where they concluded that the difference in costs between a
conventional laparoscopic and robotic fundoplication does not differ
significantly [6].
When the long-term results are evaluated, the most frequent
postoperative complication is dysphagia, with numbers ranging from
1.8% to 10% [1,25,26], usually with a poor response to endoscopic
dilation (up to 25%) [26], and without difference between robotic or
laparoscopic approach [27]. The need for antisecretory medication
is also similar [6,16,18] in the range of 5.6% to 62% [2,12,17,22], this wide difference depending on the time of follow-up, being more necessary as the observation period is longer [28]; they generally have
a good response to IBP (in the 89%) [22] and a good quality of life [16],
with 62% to 97% satisfaction with the operation in follow-up longer
than 5 years [27]; 81% to 92% referred satisfied with the procedure
and willing to do it again and 90% to 92% would recommend the
surgery [22,29].
The follow-up through the Visick scale has shown acceptable
long-term results, with a score of I or II (resolved or improved
complaints) between 73% and 90% of patients [17,30-32], being more
common in order of frequency Visick II (57.4%), Visick I (21.8%),
Visick III and IV (9%) [17]. Our results are comparable with 84.6% of
patients with Visick I or II (remission or improvement of symptoms),
without any patient Visick IV.
Robot-assisted fundoplication has been a safe and efficient
alternative, where the higher cost and surgical time are frequently cited
as drawbacks. These statements arise from published experiences with
generally modest and initial cases [21], like this series. The function of
these reports should be to determine the learning curves, and not to
compare safety and efficiency profiles against other approaches, since
this same learning curve represents a considerable bias. It would be
expected that improved experience and technology could eventually
overcome these disadvantages [33].
Table 3
Conclusion
In our initial experience we observed that the probability
of conversion and the incidence of complications are inversely
proportional to the accumulated experience.
Despite this learning curve, our results are competitive with the
experience reported in the medical literature, both conventional
laparoscopic and robot-assisted approaches.
References
- Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease (GERD). SAGES. 2010.
- Alain FRG, Elizabeth FE. Enfermedad por reflujo gastroesofágico. Rev Mex Cirug Apar Diges. 2016;5(3):96-105.
- Ortiz J. Evoluciónhistórica en el tratamiento de la enfermedad por reflujo gastroesofágico. Cir Endos. 2012;13(1):45-7.
- Ciovica R, Gadenstatter M, Klingler A, Lechner W, Riedl O, Schwab GP. Quality of life in GERD patients: medical treatment versus antireflux surgery. J Gastrointest Surg. 2006(7);10:934-9.
- Anvari M, Allen C, Marshall J, Armstrong D, Goeree R, Ungar W, et al. A randomized controlled trial of laparoscopic nissen fundoplication versus proton pump inhibitors for treatment of patients with chronic gastroesophageal reflux disease: Oneyear follow-up. Surg Innov. 2006;13(4):238-49.
- Wang Z, Zheng Q, Jin Z. Meta-analysis of robot-assisted versus conventional laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease. ANZ J Surg. 2012;82(3):112-7.
- Dallemagne B, Weerts JM, Jehaes C, Markiewicz S, Lombard R. Laparoscopic Nissen fundoplication: preliminary report. Surg Laparosc Endosc. 1991;1(3):138-43.
- Heemskerk J, Van Gemert WG, Greve JWM, Bouvy ND. Robotassisted versus conventional laparoscopic Nissen fundoplication: A comparitive, retrospective study on costs and time consumption. Surg Laparosc Endosc Percutan Tech. 2007;17(1):1-4.
- Strate U, Emmermann A, Fibbe C, Layer P, Zornig C. Laparoscopic fundoplication: Nissen versus Toupet two-year outcome of a prospective randomized study of 200 patient regardin preoperative esophageal motility. Surg Endosc. 2008:22(1);21-30.
- Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K. Long term failure of endoscopic gastroplication (endocinch). Gut. 2005;54(6):752-8.
- Huerta F, Tamayo J, Noble A, Hernández A, Torres G, Ramos A. The Mexican consensus on gastroesophageal reflux disease. Part II. Rev Gastroenterol Mex. 2013;78(4):231-9.
- Owen B, Simorov A, Siref A, Shostrom V, Oleynikov D. How does robotic anti-reflux surgery compare with traditional open and laparoscopic techniques: A cost and outcomes analysis. Surg Endosc. 2014;28(5):1686-90.
- Morino M, Pellegrino L, Giaccone C, Garrone C, Rebecchi F. Randomized clinical trial of robot-assisted versus laparoscopic Nissen fundoplication. Br J Surg. 2006;93(5):553-8.
- Markar SR, Karthikesalingam AP, Hagen ME, Talamini M, Horgan S, Wagner OJ. Robotic vs. laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease: systematic review and meta-analysis. Int J Med Robot. 2010;6(2):125-31.
- Nakadi IE, Mélot C, Closset J, DeMoor V, Bétroune K, Feron P, et al. Evaluation of da Vinci Nissen fundoplication clinical results and cost minimization. World J Surg. 2006;30(6):1050-4.
- Rebecchi F, Allaix M, Morino M. Robotic technological aids in esophageal surgery. J Vis Surg. 2017;3(7):1-6.
- Jensen J, Antonsen H, Durup J. Two years of experience with robot-assisted anti-reflux surgery: A retrospective cohort study. Int J Surg. 2017;39:260-6.
- Yao G, Liu K, Fan Y. Robotic Nissen fundoplication for gastroesophageal reflux disease: a meta-analysis of prospective randomized controlled trials. Surg Today. 2014;44(8):1415-23.
- Cundy TP, Harling L, Marcus HJ, Athanasiou T, Darzi AW. Meta analysis of robot-assisted versus conventional laparoscopic fundoplication in children. J Pediatr Surg. 2014;49(4):646-52.
- Müller B, Reiter M, Wente M, Bintintan V, Köninger J, Büchler M, et al. Robot-assisted versus conventional laparoscopic fundoplication: short-term outcome of a pilot randomized controlled trial. Surg Endosc. 2007;21(10):1800-5.
- de Vasconcellos Macedo AL, Marcondes W, Tranchesi B Jr, Steinwur F. Secrets for successful laparoscopic antireflux surgery: robotic surgery. Ann Laparosc Endosc Surg. 2017;2(67):1-4.
- Prieto E, Medina J, Brizuela C, González M, Mellín T, Gómez T. Patient satisfaction and quality of life following laparoscopic Nissen fundoplication. Rev Gastroenterol Mex. 2014;79(2):73-8.
- Tolboom RC, Draaisma WA, Broeders Ivo AMJ. Evaluation of conventional laparoscopic versus robot-assisted laparoscopic redo hiatal hernia and antireflux surgery: a cohort study. J Robot Surg. 2016;10:33-9.
- Spechler SJ, Lee E, Ahnen D, Goyal RK, Hirano I, Ramirez F, et al. Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA. 2001;285(18):2331-8.
- Garibay RR. Adverse effects and failure of proton pump inhibitors (PPI). ECOS International. 2011;76(1):1-180.
- Braghetto IM, Korn OB, Valladares H, Silva JC, Aazabache V. Indicaciones de cirugíaantirreflujo: ¿Buenos y malos candidatos para la cirugía? Revisión bibliográfica y experiencia personal. Revista médica de Chile. 2010;138:605-11.
- Brunicardi FC. Schwartz Principios de cirugía. 9a ed. Mexico: McGraw Hill; 2011.
- Katz P, Gerson L, Vela M. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2013;108(3):308-28.
- Vidal O, Lacy A, Pera M, Valentini M, Bollo J, Lacima G, et al. Long-term control of gastroesophageal reflux disease symptoms after laparoscopic nissen-rosetti fundoplication. J Gastrointest Surg. 2006;10(6):863-9.
- Rijnhart-De Jong HG, Draaisma WA, Smout AJ, Broeders IA, Gooszen HG. The Visick score: a good measure for the overall effect of antireflux surgery? Scand J Gastroenterol. 2008;43(7):787-93.
- Zsolt S, Paszt A, Géczi T, Abrahám S, Tóth I, Horváth Z. Comparison of surgical patients with gastroesophageal reflux disease and Barrett's esophagus. Magy Seb. 2014;67(5):287-96.
- Pessaux P, Arnaud JP, Ghavami B, Flament JB, Trebuchet G, Meyer C, et al. Laparoscopic antireflux surgery: comparative study of Nissen, Nissen-Rossetti, and Toupet fundoplication. Société Française de Chirurgie Laparoscopique. Surg Endosc. 2000;14(11):1024-7.
- Pushdary K. Is there a Future for Robot-assisted Laparoscopic Nissen Fundoplication (RALF)…? World J Laparosc Surg. 2013;6(1):19-22 .