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Reflux, dysphagia, and gas bloat after laparoscopic fundoplication in patients with incidentally discovered hiatal hernia and in a control group
Reflux, dysphagia, and gas bloat after laparoscopic fundoplication in patients with incidentally discovered hiatal hernia and in a control group Frederic Triponez, MD,a Jean-Marc Dumonceau, MD,b Dan Azagury, MD,a Francesco Volonte, MD,a Karem Slim, MD,c Bernadette Mermillod, PhD,d Olivier Huber, MD,a and Philippe Morel, MD,a Geneva, Switzerland, and Clermont-Ferrand, France
Background. Laparoscopic fundoplication effectively controls reflux symptoms in patients with gastroesophageal reflux disease (GERD). However, symptom relapse and side effects, including dysphagia and gas bloat, may develop after surgery. The aim of the study was to assess these symptoms in patients who underwent laparoscopic fundoplication, as well as in control subjects and patients with hiatal hernia. Methods. A standardized, validated questionnaire on reflux, dysphagia, and gas bloat was filled out by 115 patients with a follow-up of 1 to 7 years after laparoscopic fundoplication, as well as by 105 subjects with an incidentally discovered hiatal hernia and 238 control subjects. Results. Patients who underwent fundoplication had better reflux scores than patients with hiatal hernia (P = .0001) and similar scores to control subjects ( P = .11). They also had significantly more dysphagia and gas bloat than patients with hiatal hernia and controls ( P < .005 for all comparisons). Gas bloat and dysphagia were more severe in hiatal hernia patients than in controls ( P < 0.005). After fundoplication, the 25% of the patients with the shortest follow-up (1.5 ± 0.2 years) and the 25% patients with the longest follow-up (5.8 ± 0.6 years) had similar reflux, dysphagia, and gas bloat scores (P = .43, .82, and .85, respectively). Conclusion. In patients with severe GERD, laparoscopic fundoplication decreases reflux symptoms to levels found in control subjects. These results appear to be stable over time. However, patients who underwent fundoplication experience more dysphagia and gas bloat than controls and patients with hiatal hernia---symptoms that should be seen as a side effect of the procedure and of GERD itself. (Surgery 2005;137:235-42.) From the Clinic and Policlinic of Digestive Surgery, Department of Surgerya; and Clinic and Policlinic of Gastroenterology, Department of Internal Medicineb; Geneva; the Department of General and Digestive Surgery,c University Hospital, Clermont-Ferrand; and the Division of Medical Informatics, University Hospital of Genevad
LAPAROSCOPIC FUNDOPLICATION IS AN EFFICACIOUS and cost-effective alternative to the lifelong use of antacid medication (AAM) for patients with gastroesophageal reflux disease (GERD).1-3 Most studies performed with the open procedure show that GERD symptoms are well controlled without AAM more than 10 years after operation in about 90% Accepted for publication July 30, 2004. Reprint requests: Frederic Triponez, MD, Mt. Zion Medical Center, University of California–San Francisco, Box 1674, 1600 Divisadero Street, Hellman Bldg, Room C3047, San Francisco, CA 94143. E-mail: [email protected]. 0039-6060/$ - see front matter Ó 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.surg.2004.07.016
of patients,4,5 which is at least equivalent to the result obtained with proton pump inhibitor therapy.6 The results are anticipated to be similar for the laparoscopic procedure, and recent studies show a trend in this direction,7-11 although 10-year follow-up results remain unavailable at this time. The fear of postoperative complications and recurrence of such symptoms as reflux, dysphagia, and gas bloat may discourage patients from undergoing surgery.12,13 Furthermore, the possibility that long-term AAM therapy may be as effective as surgical intervention without significant related morbidity6,14,15 may decrease referrals for surgery.16,17 In recent years, dysphagia and gas bloat have been increasingly considered to be related to GERD itself rather than to occur as a complication SURGERY 235
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Table I. Preoperative findings in the fundoplication group (n = 115)
Table II. Characteristics of the hiatal hernia group (n = 105)
Characteristics
N (%)
Characteristics
EGD Metaplasia Erosion Ulceration Stenosis Manometry Severe motility disorder pHmetry Abnormal pHmetry Barium swallow Hernia > 5 cm Reflux Dysphagia
111 6 (5.5%) 19 (17%) 13 (12%) 0 104 4 (4%) 62 52 (84%) 103 21 (20%) 5 [5-8] 10 [6-10]
Diagnosed by CT scan Chest x-ray Surgical history (patients)* Upper abdominal operations Lower abdominal operations Other operations Other known hernia (patients)* Groin Umbilicus Eventration Anemia
EGD, Esophagogastroduodenoscopy; Metaplasia, histologically demonstrated intestinal metaplasia on esophageal biopsy; Abnormal pHmetry, esophageal exposure to pH < 4 during > 4% of 24-hour analysis; Reflux and dysphagia, VAS scores from 0 (severe symptoms) to 10 (no symptoms).
of the procedure.18-21 Therefore, we compared reflux, dysphagia, and gas bloat in 3 groups: patients who had undergone laparoscopic fundoplication, patients with an incidental discovery of hiatal hernia during radiological workup for unrelated symptoms, and a control group. MATERIAL AND METHODS Laparoscopic fundoplication patients. Between December 1993 and December 2001, 176 laparoscopic antireflux operations were performed at the University Hospital of Geneva. A ‘‘floppy’’ Nissen 360-degree fundoplication was performed in 172 patients, according to the technique described by Collard et al22 (ie, a 1.5-cm floppy Nissen with 1 knot taken in the esophageal wall after systematic section of the short gastric vessels and hiatal closure by suturing the diaphragmatic crura). A partial fundoplication (180-degree Toupet fundoplication) was performed in 4 patients with severe esophageal motility disorders on manometry, according to international recommendations.22,23 A calibrating dilator was not routinely placed in the esophagus. Hiatal hernia patients. Patients with hiatal hernia (n = 113) were found in the database of the Radiology Department, University Hospital of Geneva over the period 1990–2000. Reports were studied, and patients with a newly diagnosed hiatal hernia at chest x-ray or thorax or abdominal computed tomography (CT) scan were included in the series. To include patients with ‘‘incidental’’
N (%) 97 8 18 6 17 6 25 16 5 8 31
(92%) (8%) (17%) (6%) (16%) (6%) (24%) (15%) (5%) (8%) (30%)
*Some patients underwent more than 1 operation or had more than 1 hernia. Upper abdominal operations included 5 cholecystectomies and 1 splenectomy. Lower abdominal operations included 8 appendectomies, 4 colorectal resections, 3 gynecologic operations, 2 intestinal occlusions, and 1 groin hernia repair. Other operations included 2 tonsillectomies, 1 thyroidectomy, 1 nephrectomy, 1 hip prosthesis, and 1 lung resection.
hiatal hernia, operated patients (n = 9) and patients specifically followed for GERD (n = 31) were excluded. Moreover, nonoperated patients who were described as having a paraesophageal hiatal hernia on CT scan (n = 4) were not included to avoid including non–reflux-promoting paraesophageal hiatal hernia in the hiatal hernia group. (Paraesophageal hiatal hernia is more than 10 times less frequent than sliding hiatal hernia.24) Therefore, the proportion of patients with paraesophageal hiatal hernia should represent < 10% of the hiatal hernia group in the present study. Control group. A total of 256 subjects were selected from among relatives of patients hospitalized in our institution to serve as a control group. These subjects were carefully selected to have no past or present digestive disease and were asked to anonymously complete and return the questionnaire. The subjects were not matched to the fundoplication group or to the hiatal hernia group, but were chosen to be representative of a normal population in the Geneva canton in terms of age, sex, and socio-professional categories. Reflux, dysphagia, and gas bloat scores. Three scores related to GERD were derived from the gastrointestinal quality-of-life index (GIQLI), a quality-of-life questionnaire specifically developed for studying gastrointestinal diseases,25 validated in French,26 and recommended by the European Study Group for Antireflux Surgery.1 Three scores were calculated by adding those items among the 36 items included in the GIQLI that are relevant to GERD: reflux (item 27, ‘‘regurgitation,’’
Surgery Volume 137, Number 2
Fig 1. Box plots representing reflux score in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
plus item 35, ‘‘pyrosis’’), dysphagia (item 28, ‘‘reducing speed to swallow,’’ plus item 29, ‘‘having problem swallowing’’), and gas bloat (item 2, ‘‘dilated stomach,’’ plus item 3, ‘‘sensation of air in the stomach,’’ plus item 4, ‘‘flatulence,’’ plus item 5, ‘‘eructation’’). For each item, a score of 4 corresponds to ‘‘never,’’ 3 corresponds to ‘‘a little of the time,’’ 2 corresponds to ‘‘some of the time,’’ 1 corresponds to ‘‘most of the time,’’ and 0 corresponds to ‘‘all of the time.’’ The reflux and dysphagia scores may vary from 8 (best) to 0 (worst); the gas bloat score, from 16 (best) to 0 (worst). Postoperative reflux and dysphagia were considered severe (score of 0–2), moderate (3–5), minor (6–7), or absent (8). In addition to the 36 questions of the GIQLI, we added questions on AAM intake (type, frequency, and prescription by a physician or automedication), as well as on overall satisfaction for patients operated on. The questionnaire was sent to 138 patients with follow-up period longer than 1 year after fundoplication, to the patients with hiatal hernia, and to the control subjects. In the fundoplication group, preoperative reflux and dysphagia scores were assessed using a visual analogue scale (VAS) ranging from 10 (no symptoms) to 0 (severe symptoms). Preoperative reflux and dysphagia were graded as severe (score of 0-3), moderate (4-6), minor (7-9), or absent (10). Statistical analysis and graphical representation. Results are presented as median values, with quartiles 1 (Q1) and 3 (Q3) given in square brackets unless stated otherwise. The SPSS (SPSS
Triponez et al 237
Fig 2. Scatter plot and regression line of preoperative and postoperative reflux scores. Postoperative reflux scores (GIQLI) are plotted against preoperative reflux score (VAS).
Inc, Chicago, Ill) and BMDP (Statistical Solutions, Cork, Ireland) programs were used for statistical analysis, and SPSS and S-PLUS (Insightful Corp, Seattle, Wash) were used for graphical representations. Comparisons between groups were made using the Kruskal-Wallis test (in 3 groups) or the Mann-Whitney test (in 2 groups). In cases of a significant Kruskal-Wallis overall comparison, pairwise comparisons were done using Bonferroni’s correction. To test whether duration of followup affected the reflux, dysphagia, and gas bloat scores in the fundoplication group, the 25% of the patients with the longest duration of follow-up were compared with the 25% of the patients with the shortest duration of follow-up. A P value of less than .05 was considered statistically significant. Correlations were calculated using Spearman’s rank correlation. Values of 0-.25 indicate a poor relationship; .25-.5, a fair relationship; .5-.75, a moderate to good relationship; and .75-1, a very good to excellent relationship.27 RESULTS Questionnaires. The questionnaire could be analyzed for 115 of 138 (83%) patients in the fundoplication group; 19 patients were lost to follow-up and 4 had incomplete questionnaires. Patients’ characteristics are presented in Table I. The follow-up in the fundoplication group was 2.7 years (1.8-4.4 years). In the hiatal hernia group, the questionnaire could be analyzed for 105 of 113
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Table III. Characteristics of the study groups n Age (years) Male/female ratio Follow-up (years) BMI (kg/m2) Hiatal hernia No hiatal hernia < 3 cm 3-5 cm >5 cm
Fundoplication group
Hiatal hernia group
Control group
115 54 [41-65] 1.2 (63/52) 2.7 [1.8-4.4] 25.3 [23-28] 71/103 (69%) 32 37 13 21
105 78 [70-86] 0.7 (44/61) 25.4 [23-29] 105 (100%) 0 12 69 24
238 42 [35-50] 1.2 (130/108) -
P value <.001 .072 .78 <.001
BMI, Body mass index. Hiatal hernia measurement was available for 103 of the 115 patients in the fundoplication group.
(93%) patients; 6 patients were lost to follow-up and 2 patients refused to answer the questionnaire. Patient characteristics in this group are presented in Table II. For the control group, the questionnaire could be analyzed for 238 of 256 (93%) patients; 16 persons did not send back the questionnaire, and 2 questionnaires were returned incomplete. Comparison between the 3 groups. Patients in the fundoplication group were older (54 years [41-65]) than those in the control group (42 years [35-50]) (P < .0001) and younger than those in the hiatal hernia group (78 years [70-86]) (P < .0001). The body mass indices (BMIs) were similar in the fundoplication and hiatal hernia groups (P = .78). The hiatal hernias were significantly bigger in the hiatal hernia group than in the fundoplication group (P < .001) (Table III). Reflux. After fundoplication, patients had a reflux score significantly better than hiatal hernia patients (8 [6-8] and 6 [4-8], respectively; P = .0001) and not significantly different from control subjects (8 [6-8] and 8 [7-8], respectively; P = .11) (Fig 1). Nineteen (8%) of the controls had a moderate or severe reflux, and 67 (28%) had a minor reflux. At the end of follow-up, 13 patients (11%) in the fundoplication group were taking AAM occasionally (n = 8; 7%) or continuously (n = 5; 4%), compared with 100% before surgery (P < .0001) and to 62 patients (60%) in the hiatal hernia group (31 [30%] patients occasionally and 31 [30%] continuously) (P < .0001). In the fundoplication group, the 29 patients with follow-up > 4.4 years (mean ± standard deviation [SD], 5.8 ± 0.6 years) had reflux scores similar to those of the 28 patients with follow-up < 1.8 years (1.5 ± 0.2 years), 8 (5-8) and 6.5 (4.25-8), respectively (P = .43), and AAM use was similar in the 2 groups (5 patients [17%], and 4 patients [14%], respectively; P = .76). On a 10-point VAS, patients had a median preoperative reflux score of 5 (range, 5-8). Pre-
operative reflux score was not correlated with postoperative reflux score (Spearman’s correlation coefficient = 0.087; P = .39) (Fig 2). Dysphagia. Patients in the fundoplication group experienced more dysphagia than those in the hiatal hernia and control groups (median scores, 6 [4-8], 8 [7-8], and 8 [8-8], respectively; P < .0001 for both comparisons) (Fig 3). Postoperative dysphagia was graded as severe in 9 patients (8%), moderate in 39 (34%), minor in 32 (28%), and absent in 35 (30%). Preoperatively, these figures were 1 (1%), 29 (25%), 19 (17%), and 66 (57%), respectively. The 29 patients with followup > 4.4 years had similar dysphagia scores to the 28 patients with follow-up < 1.8 years (5 [4-8] and 6 [4-6.75], respectively; P = .82). Among preoperative findings, dysphagia was the single parameter correlated with postoperative dysphagia (Spearman correlation coefficient = 0.52; P < .0001) (Fig 4). No relationship was found between the detection of preoperative esophageal motility disorder, BMI, hiatal hernia size, conversion to open procedure, and cholecystectomy. Four patients with severe postoperative dysphagia received treatment (endoscopic dilation in 3 cases and early reoperation in 1 case). Dysphagia scores were lower in the hiatal hernia group than in the control group (P = .003) (Fig 2). In the hiatal hernia group, dysphagia was graded as severe in 2 patients (2%), moderate in 11 (11%), minor in 32 (30%), and absent in 60 (57%). These figures were 1 (0.5%), 7 (3%), 49 (21%), and 181 (76%), respectively, in the control group. Gas bloat. Patients in the fundoplication group experienced more gas bloat than those in the hiatal hernia group (median scores, 9 and 12, respectively; P = .006) and control group (median scores, 9 and 13, respectively; P < .0001) (Fig 5). The difference between gas bloat scores in the
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Fig 3. Box plots representing dysphagia score in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
hiatal hernia group and the control group was also statistically significant (P < .0001). In the fundoplication group, the 29 patients with followup > 4.4 years had gas bloat scores similar to those of the 28 patients with follow-up < 1.8 years (9 [6-11.5] and 9 [6.25-12], respectively; P = .85). In the hiatal hernia group, the 62 patients receiving AAM had poorer gas bloat scores than the 43 patients not receiving AAM (median scores, 10 and 13, respectively; P = .022), and scores similar to those in the fundoplication group (median scores, 10 and 9, respectively; P = .14). In the 3 study groups, gas bloat and reflux scores were correlated (Spearman correlation coefficient = 0.39 in the fundoplication group, 0.43 in the hiatal hernia group, and 0.48 in the control group). Patient satisfaction. At the end of follow-up, 74 patients (64%) stated that they were very satisfied with the operation, 36 (31%) stated that they were satisfied with the operation, and 5 (4%) stated that they were not satisfied with the operation. There was no correlation between satisfaction scores and reflux, dysphagia, or gas bloat scores (Spearman correlation coefficient = 0.08, 0.06, and 0.06, respectively). DISCUSSION In this survey, 89% of the patients did not take AAM at least 1 year after laparoscopic fundoplication and did not experience more reflux symptoms than controls (P = .11). Moreover, the reflux scores and the proportion of patients receiving AAM at
Triponez et al 239
Fig 4. Scatter plot and regression line of preoperative and postoperative dysphagia scores. Postoperative dysphagia scores (GIQLI) are plotted against preoperative dysphagia scores (VAS).
Fig 5. Box plots representing gas bloat scores in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
follow-up appear to be stable over time. Other groups have already reported that surgery at 5 years was at least equivalent to long-term use of AAM by GERD patients.6,28 Reflux symptoms are less important in the fundoplication group than in the hiatal hernia group, despite regular AAM intake by 5 (4%) patients in the former group
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and 31 (30%) patient in the latter group. This finding may suggest that antireflux surgery provides better control of reflux symptoms than medical treatment. Reflux scores and AAM use in patients with follow-up of 5.8 years were similar to those in patients with follow-up of 1.7 years, suggesting that fundoplication effectively controls GERD symptoms over time. Our finding that 21% of control subjects experienced significant reflux during the 2 weeks before completing the questionnaire are consistent with other studies reporting weekly and monthly episodes of reflux in 14-20% and 36-66% of normal subjects, respectively.29-32 The 11% of patients who experienced reflux symptoms after fundoplication can be divided into patients with a true recurrence of GERD, who can benefit from a refundoplication (2 in this series of 115 patients), and patients with symptoms attributed to GERD with no objective evidence of recurrent GERD,10,33,34 who are best treated conservatively using AAM and prokinetic medication after exclusion of a biliary reflux.35 Long-term severe dysphagia complicated fundoplication in 8% of patients, a proportion similar to that reported in previous studies.36-41 Long-term moderate dysphagia was reported by 34% of the subjects, but only 30% experienced no postoperative dysphagia, whereas 57% had no preoperative dysphagia. Many previous studies reported a small percentage of patients with postoperative ‘‘significant’’ dysphagia.37,42,43 However, few studies have reported the long-term grades of dysphagia symptoms. The present study demonstrates that patients who underwent fundoplication experienced more dysphagia than patients with hiatal hernia and controls. Fortunately, most of these dysphagia symptoms were mild and could be resolved by slightly reducing swallowing speed and/or chewing more thoroughly before swallowing, which did not decrease overall patient satisfaction, as suggested by the absence of correlation between patient satisfaction and dysphagia score. These data are also supported by the study of Kamolz et al,44 which reported mild, moderate, or severe dysphagia in 8% of patients preoperatively and 23.5% of patients postoperatively, and by the study of de Beaux et al,34 which reported new postoperative dysphagia in 30% of patients with no preoperative dysphagia. This study also confirmed the findings of previous series demonstrating a correlation between preoperative and postoperative dysphagia.45 The dysphagia rate has been related to different factors, including surgical technique (eg, division
Surgery February 2005 of short gastric vessels,46 length and ‘‘looseness’’ of the fundoplication,4 the type of wrap,42 use of a calibrating dilator41), follow-up duration, and heterogeneity among studies in dysphagia grading. The risk of gastroesophageal perforation during placement of a calibrating tube leads us to avoid using a calibrating dilator in open as well as in laparoscopic fundoplication. These precautions could possibly have changed the proportion of patients experiencing postoperative dysphagia; however, they are not uniformly recommended by all authors.40,41,47 If dysphagia is a prominent preoperative symptom, it may improve after surgery; however, if it is absent or moderate before surgery, it tends to worsen after surgery.34,48 This fact probably also contributed to postoperative dysphagia in our patients because relatively few of them (43%) experienced some degree of preoperative dysphagia, compared with other studies reporting preoperative dysphagia in up to 72% of patients.10,14 The single preoperative finding associated with postoperative dysphagia in our patients was the presence of preoperative dysphagia. Patient personality, another predictive factor of postoperative dysphagia,44,49,50 was not analyzed in the present study. The 4 patients treated for severe dysphagia had significant dysphagia at the end of follow-up (dysphagia scores of 0, 2, 4, and 5), but they were very satisfied with the operation and would have undergone it again. Similar contradictory results between dysphagia score and patient satisfaction have been reported elsewhere.10 This finding is probably related to thorough preoperative education about potential complications and side effects and to overall patient care. Dysphagia has been reported in up to 50% of patients with GERD,20,21 findings consistent with our finding of dysphagia in 43% of the patients with hiatal hernia. Various mechanisms of GERDrelated dysphagia have been considered, including esophageal inflammation, motility, and anatomy (associated with hiatal hernia). Our data demonstrating more dysphagia in patients with hiatal hernia than in controls support the role of the anatomic and functional defects associated with hiatal hernia in dysphagia. However, 70% of patients in the fundoplication group experienced some postoperative dysphagia, whereas 43% had preoperative dysphagia, suggesting that dysphagia is probably often worsened by the mechanical effect of fundoplication, at least in patients with no such symptoms preoperatively. The ‘‘regression to the mean’’ effect could be another explanation for these trends.
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Gas bloat was significantly increased in patients in the fundoplication group compared with those in the hiatal hernia and control groups. These results could suggest a direct relation between fundoplication and gas bloat. However, the significant difference between the hiatal hernia and control groups, the significant difference between the AAM and no AAM subgroups in the hiatal hernia group, and the lack of significant difference between the patients in the fundoplication group and the patients in the hiatal hernia group receiving AAM also support the possibility that gas bloat could be a side effect of GERD, as has been suggested by previous studies.51 Other authors have reported that gas bloat is an important preoperative complaint that is not increased or even diminished postoperatively, except in patients without this complaint preoperatively.10,19,34,51,52 The relationship between gas bloat and reflux in the 3 study groups also suggests that gas bloat could be more a side effect of GERD that a complication of surgery. In the present study, the incidences of reflux, dysphagia, gas bloat, and AAM use were similar in patients with follow-up of 1.5 years and patients with follow-up of 5.8 years, suggesting that the effectiveness and side effects of the procedure remain stable over that period. Similarly, Anvari et al10 reported that the incidences of reflux, dysphagia and gas bloat are not significantly different at 6 months, 2 years, and 5 years after surgery. In the present study, we compared the reflux, dysphagia, and gas bloat scores of 3 separate groups and did not randomize the patients with GERD in a prospective way. This approach reflects the reality of our study population and depicts the 3 groups with the same approach. However, this approach represents a limitation of the study because the 3 groups differ in age, sex ratio, and possibly severity of disease for the fundoplication and the hiatal hernia groups, as suggested by the fact that none of the patients in the hiatal hernia group had sought specialized medical or surgical treatment for reflux or dysphagia symptoms. In conclusion, our study demonstrates that laparoscopic fundoplication allows the GERD patient population to achieve the long-term level of reflux symptoms of the normal population with minimal morbidity. The slightly enhanced dysphagia and gas bloat symptoms are well accepted by well-informed patients. REFERENCES 1. Fuchs KH, Feussner H, Bonavina L, Collard JM, Coosemans W. Current status and trends in laparoscopic antireflux
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reflux disease without esophageal stricture. Am J Surg 1999; 177:189-92. Anvari M, Allen C. Postprandial bloating after laparoscopic Nissen fundoplication. Can J Surg 2001;44:440-4. Wetscher GJ, Glaser K, Wieschemeyer T, Gadenstaetter M, Prommegger R, Profanter C. Tailored antireflux surgery for gastroesophageal reflux disease: effectiveness and risk of postoperative dysphagia. World J Surg 1997;21:605-10. Wetscher GJ, Glaser K, Hinder RA, Perdikis G, Klingler P, Bammer T, et al. Respiratory symptoms in patients with gastroesophageal reflux disease following medical therapy and following antireflux surgery. Am J Surg 1997;174: 639-42. Collard JM, de Gheldere CA, De Kock M, Otte JB, Kestens PJ. Laparoscopic antireflux surgery: what is real progress? Ann Surg 1994;220:146-54. (SAGES) SoAGES. Guidelines for surgical treatment of gastroesophageal reflux disease (GERD). Surg Endosc 1998;12:186-8. MacArthur KE. Hernias and volvulus of the gastrointestinal tract. In: Feldman M, Scharschmidt BF, Sleisenger MH, Klein S, editors. Sleisenger & Fordtran’s gastrointestinal and liver disease. Philadelphia: Saunders; 1998. p. 318-27. Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, et al. Gastrointestinal quality of life index: development, validation and application of a new instrument. Br J Surg 1995;82:216-22. Slim K, Bousquet J, Kwiatkowski F, Lescure G, Pezet D, Chipponi J. First validation of the French version of the gastrointestinal quality of life index (GIQLI). Gastroenterol Clin Biol 1999;23:25-31. Colton T. Statistics in medicine. Boston: Little, Brown, and Company; 1974. Fernando HC, Schauer PR, Rosenblatt M, Wald A, Buenaventura P, Ikramuddin S, et al. Quality of life after antireflux surgery compared with nonoperative management for severe gastroesophageal reflux disease. J Am Coll Surg 2002;194:23-7. Raiha IJ, Impivaara O, Seppala M, Sourander LB. Prevalence and characteristics of symptomatic gastroesophageal reflux disease in the elderly. J Am Geriatr Soc 1992;40:1209-11. Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis 1976;21:953-6. Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology 1997;112:1448-56. Shaheen N, Ransohoff DF. Gastroesophageal reflux, Barrett’s esophagus, and esophageal cancer: scientific review. JAMA 2002;287:1972-81. Campos GM, Peters JH, DeMeester TR, Oberg S, Crookes PF, Tan S, et al. Multivariate analysis of factors predicting outcome after laparoscopic Nissen fundoplication. J Gastrointest Surg 1999;3:292-300. de Beaux AC, Watson DI, O’Boyle C, Jamieson GG. Role of fundoplication in patient symptomatology after laparoscopic antireflux surgery. Br J Surg 2001;88:1117-21. Collard JM. New insights into the assessment of gastroesophageal reflux disease. Acta Chir Belg 1996;96:144-9.
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36. Novitsky YW, Kercher KW, Callery MP, Czerniach DR, Kelly JJ, Litwin DE. Is the use of a bougie necessary for laparoscopic Nissen fundoplication? Arch Surg 2002;137:402-6. 37. Perdikis G, Hinder RA, Lund RJ, Raiser F, Katada N. Laparoscopic Nissen fundoplication: where do we stand? Surg Laparosc Endosc 1997;7:17-21. 38. DeMeester TR, Stein HJ. Minimizing the side effects of antireflux surgery. World J Surg 1992;16:335-6. 39. Jamieson GG, Watson DI, Britten-Jones R, Mitchell PC, Anvari M. Laparoscopic Nissen fundoplication. Ann Surg 1994;220:137-45. 40. Contini S, Zinicola R, Bertele A, Nervi G, Rubini P, Scarpignato C. Dysphagia and clinical outcome after laparoscopic Nissen or Rossetti fundoplication: sequential prospective study. World J Surg 2002;26:1106-11. 41. Walsh JD, Landercasper J, Boyd WC, Lambert PJ, Havlik PJ. Patient outcomes and dysphagia after laparoscopic antireflux surgery performed without use of intraoperative esophageal dilators. Am Surg 2003;69:219-23. 42. Hunter JG, Swanstrom L, Waring JP. Dysphagia after laparoscopic antireflux surgery: the impact of operative technique. Ann Surg 1996;224:51-7. 43. Bessell JR, Finch R, Gotley DC, Smithers BM, Nathanson L, Menzies B. Chronic dysphagia following laparoscopic fundoplication. Br J Surg 2000;87:1341-5. 44. Kamolz T, Bammer T, Pointner R. Predictability of dysphagia after laparoscopic nissen fundoplication. Am J Gastroenterol 2000;95:408-14. 45. Herron DM, Swanstrom LL, Ramzi N, Hansen PD. Factors predictive of dysphagia after laparoscopic Nissen fundoplication. Surg Endosc 1999;13:1180-3. 46. Gotley DC, Smithers BM, Menzies B, Branicki FJ, Rhodes M, Nathanson L. Laparoscopic Nissen fundoplication and postoperative dysphagia: can it be predicted? Ann Acad Med Singapore 1996;25:646-9. 47. Kamolz T, Granderath FA, Bammer T, Pasiut M, Pointner R. Dysphagia and quality of life after laparoscopic Nissen fundoplication in patients with and without prosthetic reinforcement of the hiatal crura. Surg Endosc 2002;16: 572-7. 48. Gadenstatter M, Wykypiel H, Schwab GP, Profanter C, Wetscher GJ. Respiratory symptoms and dysphagia in patients with gastroesophageal reflux disease: a comparison of medical and surgical therapy. Langenbecks Arch Surg 1999;384:563-7. 49. Bradley LA, Richter JE, Pulliam TJ, Haile JM, Scarinci IC, Schan CA, et al. The relationship between stress and symptoms of gastroesophageal reflux: the influence of psychological factors. Am J Gastroenterol 1993;88:11-9. 50. Johnston BT, Lewis SA, Collins JS, McFarland RJ, Love AH. Acid perception in gastro-oesophageal reflux disease is dependent on psychosocial factors. Scand J Gastroenterol 1995;30:1-5. 51. Slim K, Bousquet J, Kwiatkowski F, Lescure G, Pezet D, Chipponi J. Quality of life before and after laparoscopic fundoplication. Am J Surg 2000;180:41-5. 52. Hunter JG, Trus TL, Branum GD, Waring JP, Wood WC. A physiologic approach to laparoscopic fundoplication for gastroesophageal reflux disease. Ann Surg 1996;223: 673-85.
Background. Laparoscopic fundoplication effectively controls reflux symptoms in patients with gastroesophageal reflux disease (GERD). However, symptom relapse and side effects, including dysphagia and gas bloat, may develop after surgery. The aim of the study was to assess these symptoms in patients who underwent laparoscopic fundoplication, as well as in control subjects and patients with hiatal hernia. Methods. A standardized, validated questionnaire on reflux, dysphagia, and gas bloat was filled out by 115 patients with a follow-up of 1 to 7 years after laparoscopic fundoplication, as well as by 105 subjects with an incidentally discovered hiatal hernia and 238 control subjects. Results. Patients who underwent fundoplication had better reflux scores than patients with hiatal hernia (P = .0001) and similar scores to control subjects ( P = .11). They also had significantly more dysphagia and gas bloat than patients with hiatal hernia and controls ( P < .005 for all comparisons). Gas bloat and dysphagia were more severe in hiatal hernia patients than in controls ( P < 0.005). After fundoplication, the 25% of the patients with the shortest follow-up (1.5 ± 0.2 years) and the 25% patients with the longest follow-up (5.8 ± 0.6 years) had similar reflux, dysphagia, and gas bloat scores (P = .43, .82, and .85, respectively). Conclusion. In patients with severe GERD, laparoscopic fundoplication decreases reflux symptoms to levels found in control subjects. These results appear to be stable over time. However, patients who underwent fundoplication experience more dysphagia and gas bloat than controls and patients with hiatal hernia---symptoms that should be seen as a side effect of the procedure and of GERD itself. (Surgery 2005;137:235-42.) From the Clinic and Policlinic of Digestive Surgery, Department of Surgerya; and Clinic and Policlinic of Gastroenterology, Department of Internal Medicineb; Geneva; the Department of General and Digestive Surgery,c University Hospital, Clermont-Ferrand; and the Division of Medical Informatics, University Hospital of Genevad
LAPAROSCOPIC FUNDOPLICATION IS AN EFFICACIOUS and cost-effective alternative to the lifelong use of antacid medication (AAM) for patients with gastroesophageal reflux disease (GERD).1-3 Most studies performed with the open procedure show that GERD symptoms are well controlled without AAM more than 10 years after operation in about 90% Accepted for publication July 30, 2004. Reprint requests: Frederic Triponez, MD, Mt. Zion Medical Center, University of California–San Francisco, Box 1674, 1600 Divisadero Street, Hellman Bldg, Room C3047, San Francisco, CA 94143. E-mail: [email protected]. 0039-6060/$ - see front matter Ó 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.surg.2004.07.016
of patients,4,5 which is at least equivalent to the result obtained with proton pump inhibitor therapy.6 The results are anticipated to be similar for the laparoscopic procedure, and recent studies show a trend in this direction,7-11 although 10-year follow-up results remain unavailable at this time. The fear of postoperative complications and recurrence of such symptoms as reflux, dysphagia, and gas bloat may discourage patients from undergoing surgery.12,13 Furthermore, the possibility that long-term AAM therapy may be as effective as surgical intervention without significant related morbidity6,14,15 may decrease referrals for surgery.16,17 In recent years, dysphagia and gas bloat have been increasingly considered to be related to GERD itself rather than to occur as a complication SURGERY 235
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Table I. Preoperative findings in the fundoplication group (n = 115)
Table II. Characteristics of the hiatal hernia group (n = 105)
Characteristics
N (%)
Characteristics
EGD Metaplasia Erosion Ulceration Stenosis Manometry Severe motility disorder pHmetry Abnormal pHmetry Barium swallow Hernia > 5 cm Reflux Dysphagia
111 6 (5.5%) 19 (17%) 13 (12%) 0 104 4 (4%) 62 52 (84%) 103 21 (20%) 5 [5-8] 10 [6-10]
Diagnosed by CT scan Chest x-ray Surgical history (patients)* Upper abdominal operations Lower abdominal operations Other operations Other known hernia (patients)* Groin Umbilicus Eventration Anemia
EGD, Esophagogastroduodenoscopy; Metaplasia, histologically demonstrated intestinal metaplasia on esophageal biopsy; Abnormal pHmetry, esophageal exposure to pH < 4 during > 4% of 24-hour analysis; Reflux and dysphagia, VAS scores from 0 (severe symptoms) to 10 (no symptoms).
of the procedure.18-21 Therefore, we compared reflux, dysphagia, and gas bloat in 3 groups: patients who had undergone laparoscopic fundoplication, patients with an incidental discovery of hiatal hernia during radiological workup for unrelated symptoms, and a control group. MATERIAL AND METHODS Laparoscopic fundoplication patients. Between December 1993 and December 2001, 176 laparoscopic antireflux operations were performed at the University Hospital of Geneva. A ‘‘floppy’’ Nissen 360-degree fundoplication was performed in 172 patients, according to the technique described by Collard et al22 (ie, a 1.5-cm floppy Nissen with 1 knot taken in the esophageal wall after systematic section of the short gastric vessels and hiatal closure by suturing the diaphragmatic crura). A partial fundoplication (180-degree Toupet fundoplication) was performed in 4 patients with severe esophageal motility disorders on manometry, according to international recommendations.22,23 A calibrating dilator was not routinely placed in the esophagus. Hiatal hernia patients. Patients with hiatal hernia (n = 113) were found in the database of the Radiology Department, University Hospital of Geneva over the period 1990–2000. Reports were studied, and patients with a newly diagnosed hiatal hernia at chest x-ray or thorax or abdominal computed tomography (CT) scan were included in the series. To include patients with ‘‘incidental’’
N (%) 97 8 18 6 17 6 25 16 5 8 31
(92%) (8%) (17%) (6%) (16%) (6%) (24%) (15%) (5%) (8%) (30%)
*Some patients underwent more than 1 operation or had more than 1 hernia. Upper abdominal operations included 5 cholecystectomies and 1 splenectomy. Lower abdominal operations included 8 appendectomies, 4 colorectal resections, 3 gynecologic operations, 2 intestinal occlusions, and 1 groin hernia repair. Other operations included 2 tonsillectomies, 1 thyroidectomy, 1 nephrectomy, 1 hip prosthesis, and 1 lung resection.
hiatal hernia, operated patients (n = 9) and patients specifically followed for GERD (n = 31) were excluded. Moreover, nonoperated patients who were described as having a paraesophageal hiatal hernia on CT scan (n = 4) were not included to avoid including non–reflux-promoting paraesophageal hiatal hernia in the hiatal hernia group. (Paraesophageal hiatal hernia is more than 10 times less frequent than sliding hiatal hernia.24) Therefore, the proportion of patients with paraesophageal hiatal hernia should represent < 10% of the hiatal hernia group in the present study. Control group. A total of 256 subjects were selected from among relatives of patients hospitalized in our institution to serve as a control group. These subjects were carefully selected to have no past or present digestive disease and were asked to anonymously complete and return the questionnaire. The subjects were not matched to the fundoplication group or to the hiatal hernia group, but were chosen to be representative of a normal population in the Geneva canton in terms of age, sex, and socio-professional categories. Reflux, dysphagia, and gas bloat scores. Three scores related to GERD were derived from the gastrointestinal quality-of-life index (GIQLI), a quality-of-life questionnaire specifically developed for studying gastrointestinal diseases,25 validated in French,26 and recommended by the European Study Group for Antireflux Surgery.1 Three scores were calculated by adding those items among the 36 items included in the GIQLI that are relevant to GERD: reflux (item 27, ‘‘regurgitation,’’
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Fig 1. Box plots representing reflux score in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
plus item 35, ‘‘pyrosis’’), dysphagia (item 28, ‘‘reducing speed to swallow,’’ plus item 29, ‘‘having problem swallowing’’), and gas bloat (item 2, ‘‘dilated stomach,’’ plus item 3, ‘‘sensation of air in the stomach,’’ plus item 4, ‘‘flatulence,’’ plus item 5, ‘‘eructation’’). For each item, a score of 4 corresponds to ‘‘never,’’ 3 corresponds to ‘‘a little of the time,’’ 2 corresponds to ‘‘some of the time,’’ 1 corresponds to ‘‘most of the time,’’ and 0 corresponds to ‘‘all of the time.’’ The reflux and dysphagia scores may vary from 8 (best) to 0 (worst); the gas bloat score, from 16 (best) to 0 (worst). Postoperative reflux and dysphagia were considered severe (score of 0–2), moderate (3–5), minor (6–7), or absent (8). In addition to the 36 questions of the GIQLI, we added questions on AAM intake (type, frequency, and prescription by a physician or automedication), as well as on overall satisfaction for patients operated on. The questionnaire was sent to 138 patients with follow-up period longer than 1 year after fundoplication, to the patients with hiatal hernia, and to the control subjects. In the fundoplication group, preoperative reflux and dysphagia scores were assessed using a visual analogue scale (VAS) ranging from 10 (no symptoms) to 0 (severe symptoms). Preoperative reflux and dysphagia were graded as severe (score of 0-3), moderate (4-6), minor (7-9), or absent (10). Statistical analysis and graphical representation. Results are presented as median values, with quartiles 1 (Q1) and 3 (Q3) given in square brackets unless stated otherwise. The SPSS (SPSS
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Fig 2. Scatter plot and regression line of preoperative and postoperative reflux scores. Postoperative reflux scores (GIQLI) are plotted against preoperative reflux score (VAS).
Inc, Chicago, Ill) and BMDP (Statistical Solutions, Cork, Ireland) programs were used for statistical analysis, and SPSS and S-PLUS (Insightful Corp, Seattle, Wash) were used for graphical representations. Comparisons between groups were made using the Kruskal-Wallis test (in 3 groups) or the Mann-Whitney test (in 2 groups). In cases of a significant Kruskal-Wallis overall comparison, pairwise comparisons were done using Bonferroni’s correction. To test whether duration of followup affected the reflux, dysphagia, and gas bloat scores in the fundoplication group, the 25% of the patients with the longest duration of follow-up were compared with the 25% of the patients with the shortest duration of follow-up. A P value of less than .05 was considered statistically significant. Correlations were calculated using Spearman’s rank correlation. Values of 0-.25 indicate a poor relationship; .25-.5, a fair relationship; .5-.75, a moderate to good relationship; and .75-1, a very good to excellent relationship.27 RESULTS Questionnaires. The questionnaire could be analyzed for 115 of 138 (83%) patients in the fundoplication group; 19 patients were lost to follow-up and 4 had incomplete questionnaires. Patients’ characteristics are presented in Table I. The follow-up in the fundoplication group was 2.7 years (1.8-4.4 years). In the hiatal hernia group, the questionnaire could be analyzed for 105 of 113
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Table III. Characteristics of the study groups n Age (years) Male/female ratio Follow-up (years) BMI (kg/m2) Hiatal hernia No hiatal hernia < 3 cm 3-5 cm >5 cm
Fundoplication group
Hiatal hernia group
Control group
115 54 [41-65] 1.2 (63/52) 2.7 [1.8-4.4] 25.3 [23-28] 71/103 (69%) 32 37 13 21
105 78 [70-86] 0.7 (44/61) 25.4 [23-29] 105 (100%) 0 12 69 24
238 42 [35-50] 1.2 (130/108) -
P value <.001 .072 .78 <.001
BMI, Body mass index. Hiatal hernia measurement was available for 103 of the 115 patients in the fundoplication group.
(93%) patients; 6 patients were lost to follow-up and 2 patients refused to answer the questionnaire. Patient characteristics in this group are presented in Table II. For the control group, the questionnaire could be analyzed for 238 of 256 (93%) patients; 16 persons did not send back the questionnaire, and 2 questionnaires were returned incomplete. Comparison between the 3 groups. Patients in the fundoplication group were older (54 years [41-65]) than those in the control group (42 years [35-50]) (P < .0001) and younger than those in the hiatal hernia group (78 years [70-86]) (P < .0001). The body mass indices (BMIs) were similar in the fundoplication and hiatal hernia groups (P = .78). The hiatal hernias were significantly bigger in the hiatal hernia group than in the fundoplication group (P < .001) (Table III). Reflux. After fundoplication, patients had a reflux score significantly better than hiatal hernia patients (8 [6-8] and 6 [4-8], respectively; P = .0001) and not significantly different from control subjects (8 [6-8] and 8 [7-8], respectively; P = .11) (Fig 1). Nineteen (8%) of the controls had a moderate or severe reflux, and 67 (28%) had a minor reflux. At the end of follow-up, 13 patients (11%) in the fundoplication group were taking AAM occasionally (n = 8; 7%) or continuously (n = 5; 4%), compared with 100% before surgery (P < .0001) and to 62 patients (60%) in the hiatal hernia group (31 [30%] patients occasionally and 31 [30%] continuously) (P < .0001). In the fundoplication group, the 29 patients with follow-up > 4.4 years (mean ± standard deviation [SD], 5.8 ± 0.6 years) had reflux scores similar to those of the 28 patients with follow-up < 1.8 years (1.5 ± 0.2 years), 8 (5-8) and 6.5 (4.25-8), respectively (P = .43), and AAM use was similar in the 2 groups (5 patients [17%], and 4 patients [14%], respectively; P = .76). On a 10-point VAS, patients had a median preoperative reflux score of 5 (range, 5-8). Pre-
operative reflux score was not correlated with postoperative reflux score (Spearman’s correlation coefficient = 0.087; P = .39) (Fig 2). Dysphagia. Patients in the fundoplication group experienced more dysphagia than those in the hiatal hernia and control groups (median scores, 6 [4-8], 8 [7-8], and 8 [8-8], respectively; P < .0001 for both comparisons) (Fig 3). Postoperative dysphagia was graded as severe in 9 patients (8%), moderate in 39 (34%), minor in 32 (28%), and absent in 35 (30%). Preoperatively, these figures were 1 (1%), 29 (25%), 19 (17%), and 66 (57%), respectively. The 29 patients with followup > 4.4 years had similar dysphagia scores to the 28 patients with follow-up < 1.8 years (5 [4-8] and 6 [4-6.75], respectively; P = .82). Among preoperative findings, dysphagia was the single parameter correlated with postoperative dysphagia (Spearman correlation coefficient = 0.52; P < .0001) (Fig 4). No relationship was found between the detection of preoperative esophageal motility disorder, BMI, hiatal hernia size, conversion to open procedure, and cholecystectomy. Four patients with severe postoperative dysphagia received treatment (endoscopic dilation in 3 cases and early reoperation in 1 case). Dysphagia scores were lower in the hiatal hernia group than in the control group (P = .003) (Fig 2). In the hiatal hernia group, dysphagia was graded as severe in 2 patients (2%), moderate in 11 (11%), minor in 32 (30%), and absent in 60 (57%). These figures were 1 (0.5%), 7 (3%), 49 (21%), and 181 (76%), respectively, in the control group. Gas bloat. Patients in the fundoplication group experienced more gas bloat than those in the hiatal hernia group (median scores, 9 and 12, respectively; P = .006) and control group (median scores, 9 and 13, respectively; P < .0001) (Fig 5). The difference between gas bloat scores in the
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Fig 3. Box plots representing dysphagia score in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
hiatal hernia group and the control group was also statistically significant (P < .0001). In the fundoplication group, the 29 patients with followup > 4.4 years had gas bloat scores similar to those of the 28 patients with follow-up < 1.8 years (9 [6-11.5] and 9 [6.25-12], respectively; P = .85). In the hiatal hernia group, the 62 patients receiving AAM had poorer gas bloat scores than the 43 patients not receiving AAM (median scores, 10 and 13, respectively; P = .022), and scores similar to those in the fundoplication group (median scores, 10 and 9, respectively; P = .14). In the 3 study groups, gas bloat and reflux scores were correlated (Spearman correlation coefficient = 0.39 in the fundoplication group, 0.43 in the hiatal hernia group, and 0.48 in the control group). Patient satisfaction. At the end of follow-up, 74 patients (64%) stated that they were very satisfied with the operation, 36 (31%) stated that they were satisfied with the operation, and 5 (4%) stated that they were not satisfied with the operation. There was no correlation between satisfaction scores and reflux, dysphagia, or gas bloat scores (Spearman correlation coefficient = 0.08, 0.06, and 0.06, respectively). DISCUSSION In this survey, 89% of the patients did not take AAM at least 1 year after laparoscopic fundoplication and did not experience more reflux symptoms than controls (P = .11). Moreover, the reflux scores and the proportion of patients receiving AAM at
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Fig 4. Scatter plot and regression line of preoperative and postoperative dysphagia scores. Postoperative dysphagia scores (GIQLI) are plotted against preoperative dysphagia scores (VAS).
Fig 5. Box plots representing gas bloat scores in the 3 study groups. Each box represents the interquartile range (between Q1 and Q3); the horizontal line across the box represents the median value; the vertical lines extend from the box to the lowest and highest values; and the circles represent outliers (cases with values > 1.5 times the interquartile range [Q3 – Q1]).
follow-up appear to be stable over time. Other groups have already reported that surgery at 5 years was at least equivalent to long-term use of AAM by GERD patients.6,28 Reflux symptoms are less important in the fundoplication group than in the hiatal hernia group, despite regular AAM intake by 5 (4%) patients in the former group
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and 31 (30%) patient in the latter group. This finding may suggest that antireflux surgery provides better control of reflux symptoms than medical treatment. Reflux scores and AAM use in patients with follow-up of 5.8 years were similar to those in patients with follow-up of 1.7 years, suggesting that fundoplication effectively controls GERD symptoms over time. Our finding that 21% of control subjects experienced significant reflux during the 2 weeks before completing the questionnaire are consistent with other studies reporting weekly and monthly episodes of reflux in 14-20% and 36-66% of normal subjects, respectively.29-32 The 11% of patients who experienced reflux symptoms after fundoplication can be divided into patients with a true recurrence of GERD, who can benefit from a refundoplication (2 in this series of 115 patients), and patients with symptoms attributed to GERD with no objective evidence of recurrent GERD,10,33,34 who are best treated conservatively using AAM and prokinetic medication after exclusion of a biliary reflux.35 Long-term severe dysphagia complicated fundoplication in 8% of patients, a proportion similar to that reported in previous studies.36-41 Long-term moderate dysphagia was reported by 34% of the subjects, but only 30% experienced no postoperative dysphagia, whereas 57% had no preoperative dysphagia. Many previous studies reported a small percentage of patients with postoperative ‘‘significant’’ dysphagia.37,42,43 However, few studies have reported the long-term grades of dysphagia symptoms. The present study demonstrates that patients who underwent fundoplication experienced more dysphagia than patients with hiatal hernia and controls. Fortunately, most of these dysphagia symptoms were mild and could be resolved by slightly reducing swallowing speed and/or chewing more thoroughly before swallowing, which did not decrease overall patient satisfaction, as suggested by the absence of correlation between patient satisfaction and dysphagia score. These data are also supported by the study of Kamolz et al,44 which reported mild, moderate, or severe dysphagia in 8% of patients preoperatively and 23.5% of patients postoperatively, and by the study of de Beaux et al,34 which reported new postoperative dysphagia in 30% of patients with no preoperative dysphagia. This study also confirmed the findings of previous series demonstrating a correlation between preoperative and postoperative dysphagia.45 The dysphagia rate has been related to different factors, including surgical technique (eg, division
Surgery February 2005 of short gastric vessels,46 length and ‘‘looseness’’ of the fundoplication,4 the type of wrap,42 use of a calibrating dilator41), follow-up duration, and heterogeneity among studies in dysphagia grading. The risk of gastroesophageal perforation during placement of a calibrating tube leads us to avoid using a calibrating dilator in open as well as in laparoscopic fundoplication. These precautions could possibly have changed the proportion of patients experiencing postoperative dysphagia; however, they are not uniformly recommended by all authors.40,41,47 If dysphagia is a prominent preoperative symptom, it may improve after surgery; however, if it is absent or moderate before surgery, it tends to worsen after surgery.34,48 This fact probably also contributed to postoperative dysphagia in our patients because relatively few of them (43%) experienced some degree of preoperative dysphagia, compared with other studies reporting preoperative dysphagia in up to 72% of patients.10,14 The single preoperative finding associated with postoperative dysphagia in our patients was the presence of preoperative dysphagia. Patient personality, another predictive factor of postoperative dysphagia,44,49,50 was not analyzed in the present study. The 4 patients treated for severe dysphagia had significant dysphagia at the end of follow-up (dysphagia scores of 0, 2, 4, and 5), but they were very satisfied with the operation and would have undergone it again. Similar contradictory results between dysphagia score and patient satisfaction have been reported elsewhere.10 This finding is probably related to thorough preoperative education about potential complications and side effects and to overall patient care. Dysphagia has been reported in up to 50% of patients with GERD,20,21 findings consistent with our finding of dysphagia in 43% of the patients with hiatal hernia. Various mechanisms of GERDrelated dysphagia have been considered, including esophageal inflammation, motility, and anatomy (associated with hiatal hernia). Our data demonstrating more dysphagia in patients with hiatal hernia than in controls support the role of the anatomic and functional defects associated with hiatal hernia in dysphagia. However, 70% of patients in the fundoplication group experienced some postoperative dysphagia, whereas 43% had preoperative dysphagia, suggesting that dysphagia is probably often worsened by the mechanical effect of fundoplication, at least in patients with no such symptoms preoperatively. The ‘‘regression to the mean’’ effect could be another explanation for these trends.
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Gas bloat was significantly increased in patients in the fundoplication group compared with those in the hiatal hernia and control groups. These results could suggest a direct relation between fundoplication and gas bloat. However, the significant difference between the hiatal hernia and control groups, the significant difference between the AAM and no AAM subgroups in the hiatal hernia group, and the lack of significant difference between the patients in the fundoplication group and the patients in the hiatal hernia group receiving AAM also support the possibility that gas bloat could be a side effect of GERD, as has been suggested by previous studies.51 Other authors have reported that gas bloat is an important preoperative complaint that is not increased or even diminished postoperatively, except in patients without this complaint preoperatively.10,19,34,51,52 The relationship between gas bloat and reflux in the 3 study groups also suggests that gas bloat could be more a side effect of GERD that a complication of surgery. In the present study, the incidences of reflux, dysphagia, gas bloat, and AAM use were similar in patients with follow-up of 1.5 years and patients with follow-up of 5.8 years, suggesting that the effectiveness and side effects of the procedure remain stable over that period. Similarly, Anvari et al10 reported that the incidences of reflux, dysphagia and gas bloat are not significantly different at 6 months, 2 years, and 5 years after surgery. In the present study, we compared the reflux, dysphagia, and gas bloat scores of 3 separate groups and did not randomize the patients with GERD in a prospective way. This approach reflects the reality of our study population and depicts the 3 groups with the same approach. However, this approach represents a limitation of the study because the 3 groups differ in age, sex ratio, and possibly severity of disease for the fundoplication and the hiatal hernia groups, as suggested by the fact that none of the patients in the hiatal hernia group had sought specialized medical or surgical treatment for reflux or dysphagia symptoms. In conclusion, our study demonstrates that laparoscopic fundoplication allows the GERD patient population to achieve the long-term level of reflux symptoms of the normal population with minimal morbidity. The slightly enhanced dysphagia and gas bloat symptoms are well accepted by well-informed patients. REFERENCES 1. Fuchs KH, Feussner H, Bonavina L, Collard JM, Coosemans W. Current status and trends in laparoscopic antireflux
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