Langenbecks Arch SurgDOI 10.1007/s00423-008-0294-6
Symptom-focused results after laparoscopic fundoplicationfor refractory gastroesophageal refluxdisease—a prospective study
Stavros A. Antoniou & Panagiotis Delivorias &George A. Antoniou & Ioannis Natsiopoulos &Athanasios Kalambakas & Jan Dalenbäck &Charalambos Makridis
Received: 20 November 2007 / Accepted: 24 January 2008
occurred in 9%. The overall morbidity rate was 16%.
Background and aims Symptoms of gastroesophageal
reflux disease (GERD) are common in the general
Conclusion Laparoscopic fundoplication seems to be an
population. Although the results of laparoscopic fundopli-
effective treatment for severe, drug-resistant GERD. The
cation are well documented, there have been no reports on
high patient satisfaction rate and the positive therapeutic
the operative outcome in patients refractory to or with only
response in 95% of patients justify this procedure in this
partial response to medical therapy for GERD.
strictly selected group of patients.
Patients–methods Thirty-two patients with GERD, whosecontinuous high doses of medical treatment with proton-
Keywords Refractory gastroesophageal reflux disease .
pump inhibitors produced no or only partial symptom
Laparoscopic fundoplication . Symptom relief
relief, underwent laparoscopic Nissen fundoplication. Symptoms were evaluated with a standardized question-naire preoperatively and 12 months after surgery.
Results The complete follow-up evaluation was obtained in30 out of the 32 patients. The main symptoms before
Gastroesophageal reflux disease (GERD) has been recog-
surgery were regurgitation (93%), heartburn (60%), epigas-
nized as a significant public health concern, with a
tric pain (47%), and globus sensation (47%). All patients
prevalence of 10–20% in the West The vast majority
were relieved from heartburn, vomiting, and globus
of patients suffer from mild periodic symptoms. In a
sensation. Dysphagia was relieved in 75% of the patients
smaller percentage of patients, gastroesophageal reflux
and regurgitation in 86%. Dysphagia as a new symptom
causes vigorous symptoms and may lead to complicationsas severe esophagitis, esophageal stenosis, Barrett’s meta-
S. A. Antoniou (*) P. Delivorias G. A. Antoniou
plasia, and adenocarcinoma of the esophagus Appro-
priate lifestyle modifications and medical therapy have
First Surgical Department, General Hospital Papageorgiou,
satisfactory results in many symptomatic patients In
Thessaloniki Ring Road,PC 564 03 Thessaloniki, Greece
a smaller group of patients, however, fundoplication
Since its introduction in 1991, the laparoscopic Nissen
fundoplication has now become the most frequently used
Gastroenterological Department, General Hospital Papageorgiou,Thessaloniki, Greece
minimally invasive antireflux procedure throughout theworld. Numerous reports about the results of the procedure
have been published; however, there are no reports focusing
Department of Surgery, Frölunda Specialist Hospital,
on the postoperative symptom relief in patients with persistent
University of Gothenburg,Gothenburg, Sweden
and/or completely refractory symptoms in spite of high-dose
continuous medical therapy with proton-pump inhibitors
(PPIs). The aim of this study was, therefore, to prospectively
analyze the postoperative therapeutic symptomatic resultsgained by laparoscopic fundoplication in a group of patients
where one of the main and primary indications for surgical
intervention was troublesome and grave GERD with no or
only partial response to medical therapy.
Between September 2004 and March 2006, out of 102
patients consecutively referred to the special outpatientclinic with the question of surgical intervention, 32 patients
The preoperative investigation included barium esophago-
were subjected to laparoscopic antireflux surgery by means
gastric study, esophagoscopy, esophageal manometry, 24-
of Nissen fundoplication. All these patients had a long
h pH monitoring, and a questionnaire. The same document
history of GERD symptoms (mean 8.2 years). Continuous
was completed 12 months postoperatively in order to
doses of PPIs for a minimum period of 6 months incurred
no or only partial relief of their symptoms. More specifi-cally, refractory GERD symptoms to a standard dose of
PPIs (omeprazole 20 mg daily) for at least 4 months werefollowed by a therapeutic trial with a double dose of PPIs
A senior surgeon and two junior surgeons performed the
(omeprazole 40 mg daily) for 8–10 weeks. Patients not
operations, using the technique initially described by
responding to the high-dose PPI treatment were included in
Dallemagne et al. Shortly after the introduction of five
the study. The protocol algorithm for the selection of
ports in the upper abdomen, the hiatus and distal esophagus
patients participating in the study is depicted in Fig.
are dissected free, and a segment of the esophagus is
Other criteria for surgical treatment were the existence of
obtained, measuring between 5 and 8 cm in the abdomen. A
a paraesophageal hernia and Barrett’s metaplasia. Absolute
window behind the esophagus is created by opening the
exclusion criteria for the laparoscopic Nissen procedure
gastrophrenic ligament. Proximal short gastric vessels are
were the existence of severe comorbidity and the histolog-
dissected and cut, and then a wrap is formed. A 60-French
ical confirmation of esophageal cancer. Patient character-
dilator is inserted in the esophagus to provide controlled
tension of the wrap. The hiatus is approximated looselywith two nonabsorbable sutures. The floppy wrap is pulled
behind the esophagus and three sutures complete thefundoplication.
The subjective extent of the following symptoms was
evaluated: heartburn, regurgitation, dysphagia, epigastric
pain, globus sensation, vomiting, respiratory symptoms,
and upper-gastrointestinal bleeding. The subjective degreeof symptoms was evaluated using a simple verbal rating
scale with the descriptions “none,” “mild to moderate,” and
The McNemar test was used to compare the degree of each
symptom preoperatively and postoperatively. A p-value lessthan 0.05 was regarded as significant. Data are reported as
Fig. 1 Protocol algorithm for the selection of patients with refractoryto PPIs GERD symptomatology
mean±standard deviation, range, or percentage.
The complete follow-up evaluation was obtained for 30 outof the 32 patients at 12 months after surgery.
Eighteen patients (60%) showed no response to long-term
PPI treatment; 12 patients (40%) showed only partial
Baseline characteristics of the 30 patients are showed in
Table Twenty-two patients (73%) had mild esophagitis
(grade I–II); five (17%) had severe esophagitis (grade III–IV) and two patients (7%) had Barrett’s metaplasia. Three
The leading symptoms before surgery were regurgitation
patients (10%) had no evidence of esophagitis.
(93%), heartburn (60%), epigastric pain (47%), and globus
Esophageal manometry found that 18 patients (60%)
sensation (47%). The percentage of GERD symptoms found
had a low lower-esophageal-sphincter pressure (<10 mm
in our patients preoperatively is listed completely in Table
Hg) and 16 patients (53%) had manometric abnormalities,possibly impairing acid clearance from the esophageal
Perioperative complications and morbidity
Twenty-six patients (87%) had an abnormal 24-h pH
The overall morbidity rate was 16% (5/32). One serious
score and 13 (43%) had an abnormal esophageal exposure
complication occurred, an esophageal perforation, which
led to conversion to open surgery, open repair, and a
Fourteen patients (47%) had evidence of reflux on
subsequent uneventful postoperative recovery. One case of
pneumothorax occurred with no perioperative challenge ofthe respiration; thus, the operation was preceded as plannedand the succeeding postoperative chest X-ray was normal. The nasogastric tube was accidentally sutured in one case,which led to laparoscopic reoperation 2 days after the initial
Table 2 Preoperative investigation data of the 30 study patients
surgery because endoscopic attempts of removal of the tube
were unsuccessful. Visceral injuries and early wrap herni-ation did not occur in any of our patients. The absolute
numbers of perioperative morbidity are shown in Table .
Table presents the grading of GERD symptoms preoper-
atively and postoperatively. Heartburn, globus sensation,
Table 4 Absolute numbers of perioperative morbidity
Data reported as absolute number of patients unless otherwise
indicated. Mean values are reported as mean±standard error.
Table 5 Absolute numbers ofsymptoms before and after
vomiting, and respiratory symptoms improved significantly
after laparoscopic antireflux surgery (p<0.001). Persistentregurgitation in 14.3%, epigastric pain in 7.1%, and
Several reports have shown laparoscopic Nissen fundopli-
dysphagia in 25% also improved significantly after surgery
cation to be an established treatment option for chronic
GERD ]. The use of antireflux surgery in patients
Other symptoms reported at follow-up were diarrhea in
with persistent symptoms despite therapy with PPIs has
two patients and early dysphagia in 12. Persistent dyspha-
been discouraged because of the evidence that positive
gia as a new symptom at 1 year after surgery was reported
response to medical therapy is predictive of surgical success
in two patients. However, the overall incidence of dyspha-
, ]. We conducted this prospective study with the
gia after surgery was less than before surgery.
goal of studying the clinical effectiveness of the procedure
Continuous PPI therapy was used in five patients 1 year
in selected patients with severe GERD symptoms that
postoperatively. One of these patients was in this therapy
exhibited no or only partial response to PPIs.
for abdominal symptoms thought to be unrelated to reflux.
The most common preoperative symptom was regurgi-
Barrett’s metaplasia, found in two patients during their
tation, occurring in 93% of our patients, higher than 63%
preoperative investigation, has showed neither progression
reported by Ciovica et al. []. This difference is based on
nor regression 1 year after surgery. No more patient
the fact that all our patients suffered from persistent GERD;
developed Barrett’s metaplasia at 1-year follow-up.
therefore, reflux-related symptoms were significantly more
Satisfaction rate in large series varies from 62% to
intensive and more frequent. Regurgitation was fully
95% [–Eighty-seven percent of our patients
relieved in 86%, lower than 94–98% registered in previous
were satisfied with their decision to undergo surgery
reports [, while the remaining 14% of our patients
reported partial relief of the symptom.
Heartburn, vomiting, and globus sensation were totally
absent after surgery in all patients. Partial relief ofdysphagia (75%) can be explained by the nature of the
before surgery after surgery * p<0.001 ** p<0.05 Very satisfied Satisfied number of patients Dissatisfied regurgitation * dysphagia ** epigastric pain*
Fig. 2 Persistent GERD symptoms 1 year after antireflux surgeryhave improved significantly
Fig. 3 Satisfaction with results of laparoscopic Nissen fundoplication
procedure and is compatible with most referrals, reporting
patients with documented GERD but without adequate
persistent symptoms of dysphagia in 25–30% [, Mild
response to medical therapy, as for those patients surgery
dysphagia as a new symptom was registered in a low
might be the sole opportunity for a better quality of life.
percentage (9%) compared to 27% reported by Vakil et al. []. However, 40% experienced early postoperativedysphagia. Unlike most reports ], no patient required
Five patients (17%) continued being on PPI treatment
Laparoscopic fundoplication seems to be effective in the
1 year postoperatively. Two of these patients had persistent
relief of reflux symptoms even if the response to PPIs is
regurgitation with an abnormal 24-h pH score. Another
partial or absent in a selected cohort of patients with GERD.
patient suffered from mild epigastric pain; however, hispreoperative heartburn was fully relieved. Two other
patients suffered from persistent regurgitation with a normal24-h pH study. Bonatti et al. ] found 39% of patients
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A N N A L S O F T H E N E W Y O R K A C A D E M Y O F S C I E N C E SIssue: Cooley’s Anemia: Ninth Symposium Treatment options for thalassemia patients with osteoporosis Evangelos Terpos1 and Ersi Voskaridou21Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece. 2Thalassemia Center, LaikonGeneral Hospital, Athens, GreeceAddress for correspondence: Evan