Langenbecks Arch SurgDOI 10.1007/s00423-008-0294-6 Symptom-focused results after laparoscopic fundoplicationfor refractory gastroesophageal refluxdiseasea 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.
Patientsmethods 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
number of patients
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 1. Dent J, El-Serag HB, Wallander MA, Johansson S (2005) 2 years after laparoscopic antireflux surgery to be on acid Epidemiology of GERD: a systematic review. Gut 54:710–717 suppressive or promotility agents, but only half of them had 2. Stein HJ, Barlow AP, DeMeester PR, Hinder RA (1992) clinical evidence of GERD requiring therapy. This suggests Complications of gastroesophageal reflux disease. Role of the that not all patients continue being on medication for lower esophageal sphincter, esophageal acid and acid/alkalineexposure, and duodenogastric reflux. Ann Surg 216:35–43 GERD-related symptoms after surgery. However, the 3. Sarani B, Scanlon J, Jackson P, Evans SR (2002) Selection criteria presence of persistent reflux symptoms along with a among gastroenterologists and surgeons for laparoscopic antire- pathological pH study postoperatively should imply failure of the procedure to control gastroesophageal reflux.
4. Spechler SJ (1992) Comparison of medical and surgical therapy for complicated GERD in veterans. The Department of Veteran Therapy with PPIs provides symptomatic relief in as Affairs Gastroesophageal Reflux Disease Study Group. N Engl J many as 58–97% of patients [, , If patients with no or only partial response to PPIs should be considered 5. Ciovica R, Gadenstatter M, Klingler A, Lechner W, Riedl O, favorable candidates for antireflux procedures is a both Schwab GP (2006) Quality of life in GERD patients: Medicaltreatment versus antireflux surgery. J Gastrointest Surg 10:934–939 controversial and important issue. Hallerbäck and Glise 6. Wetscher GJ, Glaser K, Hinder RA, Perdikis G, Klingler P, are suggesting that the diagnosis of acid reflux is not Bammer T, Wieschemeyer T, Schwab G, Klinger A, Pointner R definite if the patient does not fully respond to high-dose (1997) Respiratory symptoms in patients with gastroesophageal PPI treatment, with a high risk of nonsuccessful symptom- reflux disease following medical therapy and following antirefluxsurgery. Am J Surg 174:639–642 atic surgical outcome. In a study by Campos et al. ], 7. Dallemagne B, Weerts JM, Jehaes C, Markiewicz S, Lombard R three factors were associated with a good outcome after (1991) Laparoscopic Nissen fundoplication: preliminary report.
laparoscopic fundoplication: a significant response to acid suppression, a typical primary symptom, and the presence 8. Bammer T, Hinder RA, Klaus A, Klingler PJ (2001) Five- to eight-year outcome of the first laparoscopic Nissen fundoplica- of an abnormal 24-h pH score. Our data on esophageal acid exposure amplify their findings, with 96% of patients with 9. Hallerbäck B, Glise H (1996) Pathophysiology in gastroesopha- an abnormal 24-h esophageal pH score preoperatively geal reflux disease: the surgeon’s view. Scand J Gastroenterol enjoying full relief of their primary symptom.
10. Catarci M, Gentileschi P, Papi C, Carrara A, Marrese R, Gaspari However, our target group of patients did not respond to AL, Grassi GB (2004) Evidence-based appraisal of antireflux medical therapy with PPIs for a minimum period of 6 months. Furthermore, a pathological 24-h pH monitoring 11. Vakil N, Shaw M, Kirby R (2003) Clinical effectiveness of and/or low esophageal sphincter pressure accompanied by laparoscopic fundoplication in a U.S. community. Am J Med 114:1–5 persistent symptoms of reflux were considered enough to 12. Rattner DW, Brooks DC (1995) Patient satisfaction following make the diagnosis of GERD in the present series. Despite laparoscopic and open antireflux surgery. Arch Surg 130:289–293; these previously expressed foreboding concerns about offering antireflux surgery to this cohort of patients, we 13. Isolauri J, Luostarinen M, Viljakka M, Isolauri E, Keyrilainen O, Karvonen AL (1997) Long term comparison of antireflux surgery thus found in this selected group that the postoperative versus conservative therapy for reflux esophagitis. Ann Surg symptomatic outcome was excellent in 95% of the patients with a very high satisfaction rate and a morbidity rate 14. Grande L, Toledo-Pimentel V, Manterola C, Lacima G, Ros E, proportionate to international reports.
García-Valdecasas JC (1994) Value of Nissen fundoplication inpatients with gastro-oesophageal reflux judged by long-term The identification of patients most probably to respond positive to laparoscopic antireflux surgery is of a great 15. Hinder RA, Filipi CJ, Wetscher G, Neary P, DeMeester TR, importance. A stronger emphasis should be given to Perdikis G (1994) Laparoscopic Nissen fundoplication is an effective treatment for gastroesophageal reflux disease. Ann Surg versus open Nissen fundoplication. A randomized, prospective trial. Scand J Gastroenterol 36:565–571 16. So JB, Zeitels SM, Rattner DW (1998) Outcomes of atypical 19. Bonatti H, Bammer T, Achem SR, Lukens F, DeVault KR, Klaus symptoms attributed to gastro-oesophageal reflux treated by A, Hinder RA (2007) Use of acid suppressive medications after laparoscopic fundoplication. Surgery 124:28–32 laparoscopic antireflux surgery: prevalence and clinical indica- 17. Campos GM, Peters JH, DeMeester TR, Oberg S, Crookes PF, Tan S, DeMeester SR, Hagen JA, Bremner CG (1999) 20. Sgouros SN, Mantides A (2006) Refractory heartburn to proton Multivariate analysis of factors predicting outcome after pump inhibitors: epidemiology, etiology and management. Diges- laparoscopic Nissen fundoplications. J Gastrointest Surg 3: 21. Crawley JA, Schmitt CM (2000) How satisfied are chronic 18. Luostarinen M, Virtanen J, Koskinen M, Matikainen M, Isolauri J heartburn sufferers with their prescription medications? Results (2001) Dysphagia and oesophageal clearance after laparoscopic of the patient unmet needs survey. Outcomes Manag 7:29–34


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