The treatment of gastroesophageal reflux disease with laparoscopic

ANNALS OF SURGERY
Vol. 228, No. 1, 40-50
© 1998 Lippincott-Raven Publishers
The Treatment of Gastroesophageal Ref lux Disease
With Laparoscopic Nissen Fundoplication
Prospective Evaluation of 100 Patients With "Typical" Symptoms
Jeffrey H. Peters, MD, Tom R. DeMeester, MD, Peter Crookes, MD, Stefan Oberg, MD, Michaela de Vos Shoop, MD,
Jeffrey A. Hagen, MD, and Cedric G. Bremner, MD
From the Department of Surgery, Division of Foregut and Pulmonary Surgery, University of Southern California, School of
Medicine, Los Angeles, Califomia
Objective
To evaluate prospectively the outcome of laparoscopic fundoplication in a large cohort of patients with typical symptoms of
gastroesophageal reflux.
Summary Background Data
The development of laparoscopic fundoplication over the past
several years has resulted in renewed interest in the surgical
treatment of gastroesophageal reflux disease (GERD).
Methods
One hundred patients with typical symptoms of GERD were
studied. The study was limited to patients with positive 24hour pH studies and "typical" symptoms of GERD. Laparoscopic fundoplication was performed when clinical assessment suggested adequate esophageal motility and length.
Outcome measures included assessment of the relief of the
primary symptom responsible for surgery; the patient's and
the physician's evaluation of outcome; quality of life evaluation; repeated upper endoscopy in 30 patients with presurgical esophagitis; and postsurgical physiologic studies in 28
unselected patients, consisting of 24-hour esophageal pH
and lower esophageal sphincter manometry.
Results
Relief of the primary symptom responsible for surgery was
achieved in 96% of patients at a mean follow-up of 21
The invention of the video laparoscope has forever
changed the face of surgery. Complex surgical procedures
Address reprint requests to Jeffrey H. Peters, MD, Associate Professor of
Surgery, University of Southern California, 1510 San Pablo St., Los
Angeles, CA 90033.
Accepted for publication December 9, 1997.
40
months. Seventy-one patients were asymptomatic, 24 had
minor gastrointestinal symptoms not requiring medical therapy, 3 had gastrointestinal symptoms requiring medical therapy, and 2 were worsened by the procedure. Eighty-three
patients considered themselves cured, 11 were improved,
and 1 was worse. Occasional difficulty swallowing not present
before surgery occurred in 7 patients at 3 months, and decreased to 2 patients by 12 months after surgery. There were
no deaths. Clinically significant complications occurred in four
patients. Median hospital stay was 3 days, decreasing from
6.3 in the first 10 patients to 2.3 in the last 10 patients. Endoscopic esophagitis healed in 28 of 30 patients who had presurgical esophagitis and retumed for follow-up endoscopy.
Twenty-four-hour esophageal acid exposure had returned to
normal in 26 of 28 patients studied after surgery. Lower
esophageal sphincter pressures had also returned to normal
in all patients, increasing from a median of 5.1 mmHg to 14.9
mmHg.
Conclusions
Laparoscopic Nissen fundoplication provides an excellent
symptomatic and physiologic outcome in patients with proven
gastroesophageal reflux and "typical" symptoms. This can be
achieved with a hospital stay of 48 hours and a low incidence
of postsurgical complications.
can now be performed with laparoscopic access, with minimal disruption of the patient's life and a marked reduction
in the pain associated with major surgery. Gastroesophageal
reflux, recognized as a clinical entity only in the mid-1930s,
is now the most prevalent upper gastrointestinal (GI) disorder in clinical practice. The reason for this is unclear, but it
may be related to high-fat, overindulgent Western dietary
habits.' Significant changes have also occurred in the un-
Laparoscopic Nissen Fundoplication for GERD
Vol. 228 No. 1
derstanding and treatment of gastroesophageal reflux dis(GERD) since it became a recognized abnormality. It is
known to be a chronic disease requiring lifelong treatment in 25% to 50% of patients.2 Further, recent large-scale
population studies have shown that the complications and
death rate from GERD have increased in the past decade.3
Antireflux surgery emerged only after it was recognized
in the 1950s that a hiatal hernia was associated with the
gastroesophageal reflux.4 It assumed a greater role when a
defective lower esophageal sphincter (LES) was identified
with advanced and difficult-to-control disease.5-7 Despite
this relatively short history, there has been a gradual advancement in surgical techniques and improvement in outcome.8 The advent of laparoscopic technology has catalyzed
renewed interest in the surgical treatment of GERD. Early
clinical studies of laparoscopic Nissen fundoplication documented successful relief of reflux symptoms in >90% of
patients.9-11 As a result, laparoscopic Nissen fundoplication
is positioned to become the standard of surgical care for
patients with GERD. Further, its popularity has significantly
increased the number of patients referred for surgical therapy. This fact has driven the need for a careful assessment
of what can be accomplished with this maturing procedure.
*
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41
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Normal Volunteers
n=35
Patients
n=100
Figure 1. Presurgical 24-hour pH scores in the patient population
compared with normal volunteers studied during the same time period.
fundoplication, and all patients were offered the alternatives
of continuing with medical therapy or undergoing antireflux
surgery.
PATIENTS AND METHODS
Patients with GERD can be divided into those with "typical" symptoms (heartburn, regurgitation, and dysphagia)
and those with "atypical" symptoms (cough, hoarseness,
and wheezing). Typical symptoms are a more reliable and
precise guide to the presence of disease, and consequently
their improvement better reflects the effectiveness of therapy. In contrast, it is more difficult to identify a cause-andeffect relation between atypical symptoms and gastroesophageal reflux. Consequently, their improvement or lack
thereof is a less reliable indication of reflux control. For
these reasons we have chosen to limit this study to the
prospective evaluation of consecutive patients with typical
reflux symptoms.
Between December 1991 and April 1996, 225 patients
underwent primary antireflux surgery at the University of
Southern California. Of these, 143 underwent laparoscopic
Nissen fundoplication. The remainder had open procedures:
transabdominal Nissen in 21, transthoracic Nissen in 22,
Belsey hemifundoplication in 8, and Collis gastroplasty and
Belsey hemifundoplication in 31. Open procedures were
performed in patients with one or more of the following
criteria: previous abdominal procedures, morbid obesity,
esophageal shortening, and poor esophageal motility. Patients were selected for surgical therapy based on chronic
daily symptoms of gastroesophageal reflux and pathologic
esophageal acid exposure on 24-hour esophageal pH study.
Most patients (70%) were taking proton pump inhibitors for
acid suppression and either had breakthrough symptoms or
more commonly desired an alternative to lifelong medication. Failure of medical therapy was not required before
The population studied consisted of 100 patients undergoing laparoscopic fundoplication in which the primary
symptom driving surgery was heartburn (n = 82), regurgitation (n = 10), or dysphagia (n = 8). Forty-three patients
were excluded: 23 had atypical symptoms of GERD, including asthma, cough, and chest pain; 17 had negative
24-hour esophageal pH monitoring (many of whom had
paraesophageal hiatal hernias); 2 had prior gastroesophageal
procedures (one myotomy, one prior antireflux procedure);
and 1 had a laparoscopic fundoplication after a lung transplant.
Diagnostic Studies
The diagnosis of GERD was confirmed by the presence
of increased esophageal acid exposure measured by 24-hour
esophageal pH monitoring (Fig. 1). Esophageal acid exposure was quantitated in each patient by a scoring system
(previously described) and by calculating the total percentage of time during which the esophageal pH was <4.12
Seventy-seven patients had nocturnal (i.e., supine) reflux.
Of these patients, reflux occurred in both the upright and
supine periods in 46 and only in the supine period in 31.
Fifteen patients had isolated upright reflux. Thirty-five
asymptomatic volunteers underwent esophageal pH and
motility testing in the same laboratory during the same time
period. These normal values were used for comparison with
presurgical and postsurgical motility studies in the patients
having laparoscopic fundoplication.
Video barium studies of the upper GI tract and upper
endoscopy were performed in all patients. A hiatal hernia
was present in 83 patients (<3 cm in 23 patients, 3 to 5 cm
42
Peters and Others
in 49, and >5 cm in 11). Twenty-two patients had a demonstrable lower esophageal mucosal ring, and 22 had
radiologic evidence of free reflux of barium from the stomach into the esophagus. On endoscopy, esophagitis was
considered to be present if grade II (linear erosions) or grade
III (coalescent erosions) changes were seen. Mucosal erythema was not included in the diagnosis of esophagitis.
Thirty-eight patients had grade II and eight patients grade
Ill esophagitis. Strictures (defined as difficulty in passing a
9-mm endoscope) were present in 6 patients, and Barrett's
esophagus (defined as any length of endoscopically visible
intestinal metaplasia) was present in 35 patients.
Stationary manometry was performed in each patient, and
LES pressure (measured at the respiratory inversion point),
overall length, and abdominal length were calculated from
the mean of the five recordings. A structurally defective
sphincter giving rise to incompetence was defined as one or
more of the following: resting pressure <6 mmHg, overall
length <2 cm, or abdominal length <1 cm.13 By these
criteria, 79% of patients had a defective LES. Before surgery, mean values were 5.7 mmHg for sphincter resting
pressure, 2.2 cm overall length, and 0.8 cm abdominal
length. A deficient abdominal length of the sphincter was
the most prevalent abnormality, occurring in 77% of patients. Sixty-seven percent had a deficient LES pressure and
57% had a short overall sphincter length.
Surgical Technique
Important technical elements included crural and hiatal
dissection, crural closure, and fundic mobilization by dividing the short gastric vessels in all patients. A short (1 to 2
cm), loose fundoplication was constructed over a 60 French
bougie by enveloping the distal esophagus with the anterior
and posterior wall of the gastric fundus. Based on the
clinical and physiologic results of our early patients,'4 several modifications were made in the technique of constructing the fundoplication. These included incorporating the
posterior vagus nerve in the fundoplication rather than excluding it, as is done in the open procedure; extending the
scope of the dissection posterior to the gastroesophageal
junction and the degree of fundic mobilization; and paying
attention to the geometry of the fundoplication such that the
anterior and posterior fundic lips were folded around the
esophagus to meet at the 9 o'clock position. Elements of the
technique that we believe are particularly important to
avoiding complications and achieving a high degree of
long-term success are highlighted.
Hiatal Dissection
The key to the hiatal dissection is identification of the
right crus. Metzenbaum-type scissors and fine grasping forceps are preferred for dissection. In all except the most
obese patients, there is a thin portion of the gastrohepatic
omentum overlying the caudate lobe of the liver (Fig. 2).
Dissection is begun by incising this portion of the gastro-
Ann. Surg. * July 1998
Figure 2. Intraoperative photograph of the initial dissection of the gastrohepatic omentum. A window is created above and below the hepatic
branch of the vagus nerve, which is spared.
hepatic omentum above and below the hepatic branch of the
anterior vagal nerve, which we routinely spare. A large left
hepatic artery arising from the left gastric artery is present in
up to 25% of patients. It should be identified and avoided.
After incising the gastrohepatic omentum, the lateral surface of the right crus becomes evident. The peritoneum
overlying the anterior aspect of the right crus is incised with
scissors and electrocautery and the right crus dissected as
much as possible from anterior to posterior. The medial
surface of the right crus leads into the mediastinum and is
entered by blunt dissection with both instruments. At this
juncture, the esophagus usually becomes evident. The right
crus is retracted laterally and the tissues posterior to the
esophagus are dissected. No attempt is made at this point to
dissect behind the gastroesophageal junction. Meticulous
hemostasis is critical. Blood and fluid tend to pool in the
hiatus and are difficult to remove. Irrigation should be kept
to a minimum. Care must be taken not to injure the phrenic
artery and vein as they course above the hiatus. A large
hiatal hernia often makes this portion of the procedure
easier because it accentuates the diaphragmatic crura. However, dissection of a large mediastinal hernia sac can be
difficult.
After dissection of the right crus, attention is turned
toward the anterior crural confluence. The tissues anterior to
the esophagus are held upward with the left-handed grasper
and the esophagus is swept downward and to the right,
separating it from the left crus. The anterior crural tissues
are then divided and the left crus is identified. The left crus
is dissected as completely as possible, including taking
down the angle of His and the attachments of the fundus to
the left diaphragm. A complete dissection of the lateral and
inferior aspect of the left crus and fundus of the stomach is
the key maneuver allowing circumferential mobilization of
the esophagus. Failure to do so results in difficulty encircling the esophagus, particularly if approached from the
right. Repositioning of the Babcock retractor toward the
Vol. 228 * No. 1
Laparoscopic Nissen Fundoplication for GERD
43
hand. We prefer tying the knots extracorporeally, using a
standard knot pusher.
Figure 3. Full dissection of the diaphragmatic crura, before suture
closure. Three to six interrupted 0 silk sutures are used to close the
crura. Exposure of the crura and the posterior aspect of the esophagus
is facilitated by traction on a Penrose drain encircling the gastroesophageal junction.
fundic side of the stomach facilitates retraction for this
portion of the procedure.
The esophagus is mobilized by careful dissection of the
anterior and posterior soft tissues within the hiatus. If the
crura have been completely exposed, dissection to create a
window posterior to the esophagus is not difficult. From the
patient's right side, the esophagus is retracted anteriorly
with the surgeon's left-hand instrument, allowing posterior
dissection with the right hand, and vice versa for the leftsided dissection. The posterior vagus nerve is left on the
esophagus. The medial surface of the left crus is identified
and the dissection is kept caudad to it. There is a tendency
to dissect into the mediastinum and left pleura. In the
presence of severe esophagitis, transmural inflammation,
esophageal shortening, or a large posterior fat pad, this
dissection may be particularly difficult. If unduly difficult, it
should be abandoned and the hiatus approached from the
left side by division of the short gastric vessels. After
posterior dissection, a grasper is passed through the surgeon's left-handed port behind the esophagus and over the
left crus. A Penrose drain is placed around the esophagus
and is used as an esophageal retractor for the remainder of
the procedure.
Crural Closure
The crura are further dissected and the space behind the
gastroesophageal junction is enlarged as much as possible.
The esophagus is retracted anterior and to the left and the
crura are approximated with three or four interrupted 0 silk
sutures, starting just above the aortic decussation (Fig. 3).
We prefer a large needle (CT1) passed down the left upper
10-mm port to facilitate a durable crural closure. Because
the space behind the esophagus is limited, it is often necessary to use the surgeon's left-handed (nondominant) instrument as a retractor. This maneuver facilitates placement
of single bites through each crus with the surgeon's right
Fundic Mobilization
Complete fundic mobilization allows construction of a
tension-free fundoplication without distortion of the fundus.
Replacing the liver retractor with a second Babcock forceps
facilitates retraction of the gastrosplenic mesentery during
division of the short gastric vessels. The gastrosplenic
omentum is suspended anteroposteriorly in a clothesline
fashion using both Babcock forceps, and the lesser sac is
entered approximately one-third the distance down the
greater curvature of the stomach (Fig. 4). The short gastric
vessels are sequentially divided with the aid of a Harmonic
Scalpel (Ethicon Endosurgery, Cincinnati, OH). An anterior-to-posterior rather than medial-to-lateral orientation of
the vessels is preferred, except for those close to the spleen.
The dissection includes dividing the posterior pancreaticogastric branches posterior to the upper stomach and continues until the right crus and caudate lobe can be seen from
the left side (Fig. 5). With caution and meticulous dissection, the fundus can be completely mobilized in almost all
patients.
Geometry of the Fundoplication
The fundoplication is created with particular attention to
the geometry of the fundus (Fig. 6). To ensure that the
posterior fundus is used in the construction of the fundoplication, it is grasped and passed behind the esophagus from
left to right rather than pulled from right to left. This is
accomplished by placing a Babcock clamp through the left
lower port and grasping the midportion of the posterior
fundus (Fig. 7). The fundus is passed behind the esophagus
to the right side. The Babcock clamp becomes visible on the
right side with an upward and clockwise twisting motion.
The anterior wall of the fundus is brought over the anterior
wall of the esophagus above the supporting Penrose drain.
Both posterior and anterior fundic lips are manipulated so
Figure 4. Photograph showing retraction of the gastrosplenic omentum, facilitating the initial steps in short gastric division.
44
Peters and Others
Ann. Surg. * July 1998
A
Plication
A
')
kpm
Wrap
Twist
A
A
p
Figure 6. The possibilities of orientation of a Nissen fundoplication. The
top box is the preferred approach; the bottom two boxes can be seen
to result in twisting of the fundoplication.
size its diameter properly. The anterior and posterior lips of
the fundoplication are sutured together using a single Ustitch of 2-0 Prolene buttressed with felt pledgets.
The most common error in constructing the fundoplication is to grasp the anterior portion of the stomach and pull
Divided
short gasftrcK
vessels
=~ ~ ~ ~ ~ ~ (k"
R. upper
L. upper
owe
R. low
B
Figure 5. (A) Complete fundic mobilization is continued by retracting
the stomach to the right and the spleen and omentum to the left and
downward. These maneuvers allow opening of the lesser sac and facilitate division of the high short gastric vessels. (B) The dissection is
continued to divide the pancreaticogastric branches so that the entire
proximal stomach is fully mobilized.
that the esophagus is enveloped without twisting the fundus
(Fig. 8). The laparoscopic visualization has a tendency to
exaggerate the size of the posterior window. Consequently,
the space behind the esophagus may be smaller than
thought. This can cause ischemia of the fundus when it is
passed behind the esophagus. If the posterior lip of the
fundoplication has a bluish discoloration, the stomach
should be returned to its original position and the posterior
window enlarged. A 60 French bougie is passed into the
stomach and the fundoplication is constructed around it to
A
,
B
Figure 7. Technique of creating the fundoplication. (A) Placement of
Babcock clamp on the posterior fundus in preparation for passing it
behind the esophagus to create the posterior or right lip of the fundoplication. Placement of the Babcock through the left lower trocar facilitates the proper angle of the instrument. (B) The posterior fundus is
passed behind the esophagus from left to right and grasped from the
right side.
Laparoscopic Nissen Fundoplication for GERD
Vol. 228 * No. 1
Ant. fundus
45
Patients who had presurgical erosive esophagitis underwent a second endoscopy procedure to determine if the
esophagitis had healed. Postsurgical physiologic studies
were performed in 28 unselected patients and consisted of
24-hour esophageal pH monitoring and LES manometry.
Quality of life was assessed with the Short Form 36 (SF-36)
health survey questionnaire in 46 patients.
Statistical Analysis
Results are reported as mean plus or minus standard error
of the mean. Comparison of proportions was made using the
Fisher's exact test.
RESULTS
Perioperative Course and Hospital Stay
Figure 8. Fixation of the fundoplication. The fundoplication is sutured
in place wfth a single U-stitch of 2-0 Prolene pledgeted on the outside.
A 60 French mercury-weighted bougie is passed through the gastroesophageal junction before fixation of the wrap to ensure a floppy
fundoplication. (Inset) Proper orientation of the fundic wrap.
it behind the esophagus. This results in twisting the gastric
fundus around the esophagus. Instead, the esophagus should
be enveloped by an untwisted fundus before suturing. Two
anchoring sutures of 2-0 silk are placed above and below the
U-stitch to complete the fixation of the fundoplication.
When finished, the stomach should remain in its original
plane, with the suture line of the fundoplication facing in the
right anterior direction and the greater curvature in the left
posterior direction. Before removing the ports, the abdomen
is irrigated, hemostasis is ensured, and the bougie is removed.
Outcome Measures
Both symptomatic and functional measures were used to
analyze the outcome of the procedure. The symptomatic
outcome was assessed by a physician other than the responsible surgeon and was considered excellent if the patient
was asymptomatic, good if the symptoms were relieved but
minor GI complaints (e.g., bloating or flatulence) persisted,
fair if the symptoms were improved but medication was
necessary for complete relief, and poor if the symptoms
were not improved. Particular attention was taken to determine if the primary symptom responsible for surgical referral was relieved. Patients were asked to make their own
assessment of the outcome of the procedure by judging
whether they were cured, improved, or worsened by the
procedure and whether they would undergo surgery again
under similar circumstances. These results were obtained by
telephone or personal interview using a standardized questionnaire at a median of 21 months after surgery. Follow-up
was complete in 95% of the study group.
All patients were admitted to the hospital the day of
surgery. Two of the patients (patients 2 and 42) were
converted to open laparotomy because of difficulty in fundic
mobilization and short gastric division. There were no
deaths. Significant complications occurred in four patients
(GI bleeding, a partial splenic infarct, heparin-induced hemothorax, and pneumonia in one patient each). Hospital
stay averaged 3.1 ± 0.2 days, decreasing from a mean of 6.3
days in the first 10 patients to 2.3 days in the last 10 patients.
Laparoscopic fundoplication took an average of 202 ± 58.5
minutes. With experience, surgical time decreased from a
mean of 236 minutes in the first 20 patients to 171 minutes
in last 10 patients (p < 0.001).
Symptomatic Assessment
Ninety-five patients were contacted at a median of 21
months after surgery (range 8 months to 5 years). Follow-up
was >4 years in 5 patients, 3 to 4 years in 12, 2 to 3 years
in 35, 1 to 2 years in 43. All patients had daily symptoms
before surgery. The primary symptom responsible for surgery was relieved in 91 of the 95 patients available for
follow-up (96%). Four patients had continued heartburn;
none had persistent regurgitation or dysphagia.
When all GI symptoms were considered, 67 patients were
asymptomatic (Table 1). When asked, 23 patients reported
occasional symptoms of bloating, flatulence, or early satiety
but required no further therapy. Three patients were improved but had persistent symptoms that required additional
therapy (heartburn in two, crampy abdominal pain in one).
Two patients were considered failures. In one, heartburn
improved, but the patient developed postsurgical regurgitation and dysphagia. The other developed daily dysphagia
that persisted >3 months after fundoplication.
Table 2 shows the patients' evaluation of their outcome.
When asked whether the operation cured, improved, or
worsened their symptoms, 99% of patients (94/95) were
either cured or improved. Some form of antireflux medica-
46
Peters and Others
Ann. Surg. * July 1998
Table 1. PHYSICIANS ASSESSMENT
Outcome
Excellent
Good
Fair
Failure
Number of Patients
(n = 95) (%)
Definition
Asymptomatic
Relief of primary symptom,
but minor GI symptoms,
no therapy
Improved, persistent GERD
symptoms, therapy
required
Not improved and/or long
term dysphagia as a
consequence of surgical
therapy
67 (71)
23 (24)
3 (3)
Table 3. ANTIREFLUX MEDICATION
BEFORE AND AFTER SURGERY
Type
Preoperative
(n = 100)
Postoperative
(n = 95)
Proton pump inhibitor
H2-blocker
Prokinetic
Antacids
None
47
29
8
6
10
1
1
1
1
91
2 (2)
the one who returned for postsurgical pH studies had
persistent increased esophageal acid exposure.
a
GERD = Gastroesophageal reflux disease.
Physiologic Assessment
tion was taken by 90% of patients before surgery; 47% of
them took proton pump inhibitors (Table 3). After surgery,
only four patients required any form of acid suppression or
prokinetic therapy.
Side Effects of the Procedure
The most common symptom after surgery was a tempodifficulty in swallowing that lasted <3 months and
occurred in 47 patients. Increased flatus occurred in 45
patients and occasional bloating or early satiety in 42 (Table
4). Twenty-four patients reported the inability to vomit,
although none of these had discomfort as a result. Most
patients (76) could belch after fundoplication. Seven patients had dysphagia >3 months after surgery: in five it was
occasional, in one weekly, and in one daily. By 13 months
after surgery, dysphagia had resolved in all but one patient
(Fig. 9). When all patients with presurgical dysphagia were
considered together, dysphagia improved after surgery.
rary
Healing of Esophagitis
Forty-six patients had erosive esophagitis before surgery,
38 grade II and 8 grade III. Of these, 30 returned for
follow-up endoscopy, and esophagitis was completely resolved in 28 (93%). Two patients had persistent esophagitis;
Table 2. PATIENTS ASSESSMENT
OF OUTCOME
All patients were asked before surgery to return for
postsurgical manometric studies. Twenty-eight agreed to
undergo studies both before and after surgery. LES characteristics were significantly improved from presurgical values (p < 0.001). Figure 10 shows that the Nissen fundoplication restored LES pressure, overall length, and abdominal
length to normal. Esophageal acid exposure returned to
normal in 26 of 28 patients (Fig. 11). The two in whom it
did not return to normal had markedly reduced acid exposure. Mean composite acid scores decreased from 50 to <5
(normal < 14.8, p < 0.05), and the mean percentage of time
the esophagus was exposed to pH < 4 was also reduced to
less than the normal range of <4.3% (p < 0.05).
Quality of Life Analysis
Quality of life before and after surgery was assessed
using the SF-36 standardized instrument. This evaluation
began approximately halfway through the accrual of patients for this report. Consequently, the final 46 consecutive
patients were evaluated before surgery, and 43 of the 46
were evaluated again after surgery. The scores were compared with each other and with an age- and gender-matched
U.S. population. After surgery, the scores for bodily pain
improved significantly (p < 0.01; Table 5). When the patients were asked to compare their current general health to
Table 4. SIDE EFFECTS
OF THE OPERATION
Status
Number of Patients
(n = 95) (%)
Side Effect
Number of Patients
(n = 95) (%)
Cured
Improved
Worsened
Satisfied with surgery
Would have surgery again
83 (87)
11 (12)
1 (1)
83 (87)
89 (94)
Temporary swallowing discomfort
Dysphagia > 3 months
Increased flatus
Complaints of bloating
Inability to belch
Inability to vomit
47 (50)
7 (7)
45 (47)
42 (44)
19 (20)
24 (25)
Laparoscopic Nissen Fundoplication for GERD
Vol. 228 No. 1
Prevalence (%)
10
50
8
47
% Time pH < 4
40
6.
. -------------------------------------------------------i
30
4
20
10
3mo 6mo 9mo 12mo 15mo 18mo 21mo 24mo
Figure 9. Prevalence of dysphagia related to length of time after surgery.
Pre-op
that 1 year before the surgical procedure (5 = much better,
4 = somewhat better, 3 = same, 2 = somewhat worse, 1 =
much worse), they reported a significant improvement
(4.51 ± 0.87 after vs. 2.65 ± 0.5 before, p < 0.01). We did
not find differences in the scores for the mental health,
emotional state, social functioning, vitality, physical state,
and physical functioning categories.
DISCUSSION
Laparoscopic fundoplication was introduced into clinical
practice in 1991.15 Even though no prospective randomized
trials have been conducted comparing its efficacy to that of
proton pump inhibitor therapy, evidence is rapidly accumulating to indicate that the procedure is highly effective in
controlling symptomatic gastroesophageal reflux.9-1 1,16-18
This study has shown that laparoscopic fundoplication relieved the "typical" symptoms of heartburn, regurgitation,
and dysphagia in 95% of patients for up to 4 years. Erosive
esophagitis was healed in 90% of patients returning for
follow-up endoscopy, and 24-hour ambulatory esophageal
pH profiles returned to normal in 92% of patients tested > 1
mmHg
201
15
10
5-
0
0
Restng
Pressure
Overall
Length
Abdominal
Length
Figure 10. LES characteristics in 35 normal volunteers (left bars), 100
patients before surgery (middle bars), and 26 patients after surgery
(right bars). p < 0.001 vs. other groups.
Post-op
Figure 11. Twenty-four-hour pH scores in 26 patients before and after
surgery. Shaded area represents normal range.
year after surgery. Hunter et al.'l Hinder et al."' have also
reported >90% improvement in symptoms and a similar
reduction in esophageal acid exposure measured by 24-hour
pH monitoring.
These results can be achieved by a single therapeutic
intervention with minimal discomfort and minor disruption
of the patient's life.'9'20 Although the invasive nature of
surgery is associated with risk, complications are uncommon after laparoscopic fundoplication and those that do
occur tend to be minor. Gastric and esophageal perforations
are among the most serious complications reported. They
are probably a consequence of inadequate experience with
the laparoscopic technique and unfamiliarity with the hiatal
anatomy.2' No foregut perforations occurred in our patients.
The goal of surgical treatment for GERD is to relieve the
symptoms of reflux by reestablishing the gastroesophageal
barrier. The challenge is to accomplish this without inducing dysphagia or other untoward side effects. Dysphagia
present before surgery usually improves after laparoscopic
fundoplication.2224 Temporary dysphagia is common after
surgery (perhaps even desirable) and generally resolves
within 3 months. Dysphagia persisting >3 months has been
reported in up to 10% of patients. Dysphagia (i.e., occasional difficulty swallowing solids) was present in 7% of
our patients at 3 months, 5% at 6 months, 2% at 12 months,
and in a single patient at 24 months after surgery. Others
have observed a similar improvement in postsurgical dysphagia with time.24 Induced dysphagia is usually mild, does
not require dilatation, and is temporary. It can be induced by
technical misjudgments, but this explanation does not hold
in all instances. In experienced hands, its prevalence should
be <3% at 1 year.8
It is our firm belief that widespread application of laparoscopic Nissen fundoplication in patients without objective
documentation of increased esophageal acid exposure by
24-hour esophageal pH monitoring and the identification of
deficits in esophageal length or function will lead to poor
results in a significant number of patients. Physiologic assessment before antireflux surgery is particularly important
AC
,VW
Peters and Others
Ann. Surg. * July 1998
Table 5. SF-36 HEATH ASSESSMENT SCORES
n = 46
Postoperative
n = 43
p Value
General
Population
Population by
Age & Gender
62
62
83
68
58
56
71
84
76*
64
84
74
64
62
84
88
0.01
0.63
0.87
0.24
0.22
0.1
0.11
0.35
75
75
81
82
61
72
81
84
70
75
80
81
60
66
75
78
Preoperative
Bodily pain (BP)*
Mental health (MH)
Role emotional (RE)
Social functioning (SF)
Vitality (VT)
General health (GH)
Role physical (RP)
Physical functioning (PF)
because of the lessened threshold for surgical referral
brought about by the rising popularity and enthusiasm for a
minimally invasive surgical approach.25 Patients with gastroesophageal reflux who have a relatively early form of the
disease and can be managed with intermittent acid suppression therapy do not need antireflux surgery. When chronic
daily acid suppression therapy is necessary, particularly if
proton pump inhibitors or dose escalation is required to
control symptoms, antireflux surgery should be discussed as
an option.
Traditionally, the presence of esophagitis has been the
primary criteria to identify patients with severe disease who
are candidates for surgical therapy. This remained true in
the early years of laparoscopic fundoplication, but the excellent outcome achieved with the procedure has encouraged reevaluation of this guideline. Many now consider
antireflux surgery in patients who do not have esophagitis
but are dependent on proton pump inhibitors to remain
symptom-free. This is particularly true in patients younger
than 50 years and those at risk for severe disease. Studies of
the natural history of GERD have suggested that approximately 25% of patients fall into this category.26 High-risk
features include supine reflux,27 a structurally defective
LES,28 reflux of a mixture of gastric and duodenal juice,29'30
and the presence of severe esophagitis,31 stricture, or Barrett's esophagus at the initial endoscopy.32 In these patients,
the need for long-term medical therapy is likely and may be
problematic. We believe these patients should be identified
early and given the option of laparoscopic fundoplication if
their physiology and anatomy permit.33
The advent of the laparoscopic approach provides an
ideal opportunity to standardize the technique of Nissen
fundoplication because it markedly limits the technical variability that can occur with the open procedure.34 When the
technical aspects of the procedure are agreed on, the referring physician can have greater confidence in a predictable
outcome, once the properly trained surgeon has experience
with 30 to 50 procedures. For the present, considerable
discussion continues regarding the importance of technical
aspects such as the orientation of the fundoplication and the
need for fundic mobilization and crural closure. It has
become clear that failure to close the diaphragmatic hiatus
by approximating the crura during fundoplication has resulted in a high prevalence of migration of the fundoplication into the chest.35 Routine crural closure prevents this
problem. It is also clear that dysphagia may result from
undue lateral tension on the fundoplication from undivided
short gastric vessels and the resultant incomplete mobilization of the fundus.36
Recent studies have suggested that the learning curve for
laparoscopic procedures, including cholecystectomy and
fundoplication, is in the range of 35 to 50 procedures.37'38
At the present rate of surgical referral, most surgeons encounter only a handful of patients with gastroesophageal
reflux each year. This makes it difficult to develop technical
expertise. Although the advent of laparoscopic fundoplication has increased both patient and physician acceptance of
antireflux surgery, most of these procedures are concentrated in centers with demonstrated interest in the surgical
treatment of gastroesophageal reflux. The teaming of a
gastroenterologist with a GI surgeon allows both to increase
their experience of using surgery to treat this disease. In so
doing, they bring a balanced approach that becomes an
important community resource.
Quality of life analyses have become an important part of
surgical outcome analysis. Both generic and disease-specific questionnaires have been used in an attempt to quantitate quality of life before and after medical intervention. In
general, these measures attempt to relate the effect of disease management to totheuseoverall
the well-being of the patient. 39-41 We electedtoueheSSF-36 instrument because
it is rapidly administered and well validated. This questionnaire measures 12 health-related quality of life parameters,
encompassing mental and physical well-being. Our data
indicate significant improvement in scores for the area of
bodily pain and in a portion of the general health index.
Most other measures were improved but failed to achieve
statistical significance. Laycock et al.42 also analyzed SF-36
scores before and after laparoscopic antireflux surgery. In
contrast to our data, scores in all fields were significantly
better after surgery; however, their presurgical scores were
dramatically lower than ours. Thus, the difference is probably secondary to the relatively high scores of our patients
before surgery (perhaps indicating good disease control on
Vol. 228 * No. 1
medical therapy) and to our small sample size. We continue
to accrue such data for further analysis.
Other investigators have also reported improvement in
quality of life after antireflux surgery. Glise et al.43 used two
standardized and validated questionnaires, the Psychological General Well-Being Index and the Gastrointestinal
Symptom Rating Scale, to evaluate quality of life in 40
patients after laparoscopic antireflux surgery. Scores with
both instruments were improved after antireflux surgery and
were better than in untreated patients. The scores were as
good as or better than those of patients receiving optimal
medical therapy. Velonovich et al.,44 using a 10-item
health-related quality of life questionnaire specific for
GERD, also showed an improvement in quality of life after
antireflux surgery."
We conclude that laparoscopic fundoplication will abolish gastroesophageal reflux and relieve the typical symptoms of the disease in >90% of patients. Symptomatic relief
has persisted for up to 4 years after surgery, and there is
every reason to expect that the effect will persist for the life
expectancy of the patients.
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