GERD Health-related Quality Of Life Research Articles

1019 Perioperative Treatment with Infliximab (IFX) in Patients with Crohn's (CD) and Ulcerative Colitis (UC) Is Not Associated with Increased Rate of Postoperative Complications

Background: Laparoscopic repair of giant paraesophageal hernias (LRGPEH) is increasingly utilized with excellent short-term results. Long-term (>60 months) clinical and radiographic results, however, are poorly described. Our objective was to evaluate the long term results after minimally invasive repair of GPEH. Methods: We performed a review of patients undergoing elective LRGPEH (1995 to 2002) who had a minimum of 60-month clinical or radiographic follow-up. Clinical outcomes, barium swallow and quality-of-life measures were reviewed. Results: There were 256 patients who underwent LRGPEH in this time-period. A minimum of 60-month clinical or radiographic follow-up was available on 105 patients. Hernia reduction, sac excision, crural repair (13.7%mesh-reinforcement) and fundoplication were performed in 98%. A Collis-gastroplasty was performed in 89 patients (85%). Median time for clinical follow-up was 82 months (60-124). GERD-Health-Related-Quality-of-Life (GERD-HRQL) scores were available for 98 patients, with a mean 3.9 ±6 (median 1, range 0-23; 0=no symptoms-45= worst). Occasional heartburn and dysphagia to solids were the most common persistent symptoms in 30% of patients. According to the GERD-HRQL scale (excellent=0-5; good=6-10; fair=11-15; poor=16-45), the results were excellent to good in 86.8% of patients, confirming themild nature of the symptoms. Barium-swallowwas obtained in 79/105 (75%) at a median time of 80 months (60-126). Radiographic recurrence of a hiatal hernia was identified in 9 (11%). GERD-HRQL scores were excellent in 77% of patients with radiographic recurrence compared to 72% in patients without radiographic recurrence. When patients were queried regarding satisfaction with surgery, over 90% (83/90) were satisfied or very satisfied. Re-operation was required in 5 (4.7%) patients for symptomatic recurrence at a median 44 months post-operative (range 8-80). Conclusions: This report summarizes the long-term results (7 years) of LRGPEH in 105 patients. Reoperation was required for symptomatic recurrence in only 4.7%. The GERD-related quality of life was well preserved and 90% of patients were satisfied with their surgery.

Laparoscopic revision of Nissen fundoplication to Roux-en-Y gastric bypass in morbidly obese patients

We present a case of a morbidly obese patient with previous laparoscopic Nissen fundoplication (LNF) who was successfully treated by revision to a laparoscopic Roux-en-Y gastric bypass (RYGB) and discuss our collective experience. Between June 2000 and April 2006 seven morbidly obese patients with mean body mass index (BMI) of 39.4 kg/m(2) underwent laparoscopic revision of LNF to RYGB by our group. Important steps of the revision include lysis of all adhesions between the liver and the stomach, dissection of the diaphragmatic crura and gastroesophageal fat pad, reduction and repair of hiatal hernia and complete take-down of the wrap to avoid stapling over the fundoplication which can create an obstructed, septated pouch. There was one (14.3%) conversion. Mean operative time (OT) was 324 (206-419) minutes and length of stay was 4.9 (3-8) days. Early complications occurred in 3/7 (42.9%) patients including a staple line hemorrhage without a need for re-exploration, a small pulmonary embolism without hemodynamic instability and a small-bowel obstruction due to a pre-existing incisional ventral hernia that was not repaired on original operation. There were no anastomotic leaks or deaths. At a mean follow-up of 32.9 (12-39) months, mean percentage excess weight loss was 79.5% and 18/28 (64.3%) comorbid conditions were improved or resolved. Gastroesophageal reflux disease (GERD) evaluation with the GERD health-related quality of life (GERD-HRQL) scale showed a significant reduction of GERD scores postoperatively (16.7 versus 4.4). Although laparoscopic RYGB after antireflux surgery is technically difficult and carries higher morbidity, it is feasible and effective in the treatment of recurrent GERD in morbidly obese patients.

Endoscopic full-thickness plication (Plicator) with two serially placed implants improves esophagitis and reduces PPI use and esophageal acid exposure

Recently, several endoluminal procedures for the treatment of gastroesophageal reflux disease (GERD) have been introduced. Most of these techniques have been abandoned because they lack long-term efficacy or have serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator was shown to be effective at controlling reflux symptoms and esophageal acid exposure. In all previous studies, only a single implant was used. The aim of the present pilot study was to determine the safety and efficacy of two serially placed Plicator implants. Thirty-seven patients requiring maintenance therapy with proton pump inhibitors (PPIs) were enrolled in this single-center pilot study. All patients received two Plicator implants. Exclusion criteria were hiatus hernia larger than 3 cm, grade IV esophagitis, Barrett's esophagus, and esophageal motility disorders. The primary study end point was at least 50 % improvement in the GERD Health-Related Quality of Life (HRQL) score. Secondary end points included GERD medication use, esophageal acid exposure, esophagitis grade, and heartburn/regurgitation scores. Thirty-seven patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months after treatment, the proportion of patients achieving at least 50 % improvement in GERD-HRQL score was 68 %. Complete cessation of PPI treatment was achieved in 59 % of patients. In pH studies conducted at 6 months (n = 29), median percentage of time for which pH was below 4 decreased by 36 %, with 28 % of patients experiencing pH normalization. There were no serious adverse events requiring intervention. Endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, medication use, and esophageal acid exposure.

Quality of life and patient satisfaction 3 months and 3 years after laparoscopic nissen′s fundoplication

Background/Aim:This study is based on studying the quality of life and degree of satisfaction among gastroesophageal reflux disease (GERD) patients after Laparoscopic Nissen's fundoplication (LNF) operations.Summary Background Data:A GERD patient is most interested in symptom relief, whereas his surgeon will also be interested in the improvement of anatomical and functional investigations. Materials and Methods: One hundred patients with symptoms of GERD, adequate motility study and positive 24-hour pH studies underwent LNF in El-Mansoura Gastroenterology Center between 2002 and 2004. All patients completed the Gastroesophageal Reflux Disease-Health Related Quality Of Life (GERD-HRQL) questionnaire both pre- and postoperatively (early within 3 months after operation and late after 3 years). Furthermore, all patients were given a form with 4 grades (excellent, good, fair and poor) and they were requested to freely assess both the early and late clinical outcomes.Results:There was statistically significant improvement in all the items of the GERD-HRQL questionnaire, both early and late (P < 0.001). With regard to patient satisfaction; only 58 cases showed excellent clinical satisfaction early postoperatively, while 29, 8 and 5 patients showed good, fair and poor responses, respectively. These figures improved on late followup (P < 0.05), i.e., 76 excellent, 16 good and 8 fair results.Conclusions:LNF improves all the items of quality of life among GERD patients significantly (P < 0.001). Patient satisfaction after LNF improves with time; 58 cases showed early postoperative excellent clinical satisfaction as compared to 76 late cases (P < 0.05). However, LNF may not be the standard management of reflux symptoms, particularly from some patients' perspective.

Endoscopic Full-Thickness Plication for the Treatment of GERD: 12 Month Follow-Up in the Sham-Controlled Trial

Purpose: To evaluate the safety and efficacy of the NDO Plicator endoscopic procedure for the treatment of symptomatic GERD in a cohort of patients followed out to 12 months from their original participation in a sham-controlled study. Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled. Excluded from treatment were patients with esophageal dysmotility, esophagitis grade III or IV (Savary-Miller), Barrett's epithelium, and hiatus hernia >2 cm. All patients received a single, endoscopically placed full-thickness plication in the anterior gastric cardia. The primary study endpoint was ≥50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included VAS, SF-36, GERD medication use, and esophageal acid exposure. Results: A total of 148 patients were treated at 14 study sites. No re-treatments were performed. Twelve-months post-plication, 59/96 patients (62%) had improved their GERD-HRQL score by at least 50%. Median percent change in GERD-HRQL score (62%), VAS score (46%), heartburn score (67%) and regurgitation score (50%) were all significantly improved compared to off meds baseline values. The need for daily PPI therapy was either eliminated or reduced by at least half in 63% of patients at 12-months post-treatment. There were no new or late onset adverse events. Conclusion: At 12-months post-procedure, the cohort originally treated with full-thickness plication with the Plicator and the cross-over group treated after sham showed the endoscopic treatment to be safe and effective in reducing GERD symptoms and medication use.

Tradução e validação para a língua portuguesa (Brasil) de instrumentos específicos para avaliação de qualidade de vida na doença do refluxo gastroesofágico

Gastroesophageal reflux disease has been shown patients to alter quality of life and working productivity. Most of the instruments available for this type of assessment come from English or French speaking countries. To use these instruments in Brazil requires a judicious process of translation and validation. Translating to Portuguese the questionnaires GSAS (Gastroesophageal Reflux Disease Symptom Assessment Scale), GERD-HRQL (Gastroesophageal Reflux Disease - Health Related Quality of Life) and HBQOL (Heartburn Specific Quality of Life Instrument) specific for quality of life assessment in gastroesophageal reflux disease. Testing the psychometric properties of reliability and validity of the referred disease specific instruments. One hundred and thirty two gastroesophageal reflux disease patients (mean age 54.9 years and +/- SD 13.9) from the Digestive Disease Motility Outpatient Clinic, Federal University of São Paulo, SP, Brazil and the Department of Surgical Gastroenterology "São José do Rio Preto" School of Medicine, São José do Rio Preto, SP, Brazil, accepted to participate and signed the informed consent form. Forty of these patients took part in the pre-test phase (28 females and 12 males, mean age 55.3 years +/- SD 14.7) and the remaining 92 part in the validation phase (64 females and 28 males, mean age 54.7 years and +/- SD 13.7). The translation and cultural adaptation processes were carried out accordingly us to the method of Guillemin et al (1993). The validation processes of the disease specific translated questionnaires (GSAS, GERD-HRQL and HBQOL) was performed in relation to a generic (SF-36) and a symptomatic (SQGERD) instrument. Nine words of the GSAS, four of the GERD-HRQL and six of the HBQOL were replaced during the cultural adaptation phase. The GSAS questionnaire was discontinued after this phase because of scoring problems. Therefore reliability and validity were tested only for the two remaining questionnaires. These questionnaires proved to be reproducible for both inter and intra-observer relationships (0.980 and 0.968 values for the GERD-HRQL and varying values of 0.868 to 0.972 for the HBQOL). The HBQOL questionnaire demonstrated high internal consistency (>0.70) for three of the four dimensions tested (physical aspect, pain, sleep). Good correlations levels with the SF-36 and SQGERD questionnaires were demonstrated during the validation phase. The cross cultural adaptation of the Portuguese (Brazil) versions of the GERD-HRQL and HBQOL instruments proved to be reliable and valid options with low burden level for assessment of quality of life in gastroesophageal reflux disease our country. The HBQOL is the only multidimensional questionnaire for quality of life assessment in gastroesophageal reflux disease currently available in Brazil. The Portuguese (Brazil) version of the GSAS instrument proved inadequate for quality of life assessment in our country.

The development of the GERD-HRQL symptom severity instrument

The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument was introduced approximately 10 years ago to provide a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). Since that time the instrument has been used to assess treatment response to medication, endoscopic procedures, and surgery for GERD. However, the development of the instrument has progressed over the course of several years, and there is no one source which reviews this progress. The purpose of this article is to summarize the development and testing of the GERD-HRQL. The GERD-HRQL was initially developed to measure the typical symptoms of GERD. It was initially determined to have face validity and subsequent studies assessed its content validity, criterion validity, concurrent validity, predictive validity and construct validity. Reliability was determined by the test-retest method. Responsiveness was determined by the effects of treatment. This instrument is practical, with little administrative burden. There are few missing responses. Because there are 51 possible scores, the instrument has a high level of precision; and because of the response anchors, cannot have a floor effect, and only 4/372 patients reached the highest score of 50, implying little ceiling effect. The instrument has been translated into several languages, and appears valid, reliable and practical in each.

Endoluminal gastroplication for the treatment of gastroesophageal reflux disease: A 2‐year prospective pilot study from Taiwan

Endoluminal gastroplication (ELGP) offers a minimally invasive option for the treatment of gastroesophageal reflux disease (GERD) in Western countries. However, long-term outcomes of ELGP in Asian populations have not been investigated. The aim of this prospective study was to evaluate the long-term benefits of ELGP in Asian patients with GERD. Taiwanese patients diagnosed with GERD were enrolled and had the procedure performed with EndoCinch. The assessment included symptom scoring, validated GERD questionnaires, esophagogastroduodenoscopy, esophageal manometry and 24-h pH monitoring before and after the procedure over a 2-year period. Twenty-one consecutive patients were recruited and underwent ELGP. Patients reported improved heartburn symptom score (mean 64.0 vs 21.1, P < 0.001), regurgitation frequency score (mean 2.4 vs 1.3, P < 0.001), and GERD health-related quality of life (mean 23.1 vs 10.1, P < 0.001) at 24 months. The mean total time of pH < 4 reduced from 121.7 min to 67.1 min (P = 0.008) and mean DeMeester score reduced from 32.9 to 17.6 (P = 0.011) at 3 months. Antisecretory drug discontinuation rate was 81%, 57%, 52% and 48% at 1, 6, 12 and 24 months, respectively. Of the patients who had a favorable initial response to ELGP at 1 month, 41% resumed antisecretory medications at 24 months follow-up. All adverse events were mild and transient. Endoluminal gastroplication is a safe and modestly effective endotherapy for patients with GERD. It significantly improved symptoms in an Asian population. Approximately one in two patients continues to be off medication at 24 months follow-up. However, the long-term efficacy and durability are still to be determined.

Assessment of Quality of Life after Laparoscopic Nissen Fundoplication in Patients with Gastroesophageal Reflux Disease

In this study two different quality of life items are compared, and correlation of patient satisfaction with preoperative and postoperative symptoms after laparoscopic Nissen fundoplication (LNF) for chronic gastroesophageal reflux disease is evaluated. Between December 2002 and December 2004, 60 patients with a diagnosis of chronic gastroesophageal reflux disease scheduled for laparoscopic Nissen fundoplication were recruited prospectively and volunteered to participate in this study. Patients underwent endoscopy, and their disease-specific symptoms were scored on a scale. Quality of life was measured preoperatively and in the first and sixth postoperative months with two questionnaires: Short Form-36 (SF 36) (preoperatively) and the Gastroesophageal Reflux Disease - Health-Related Quality of Life (GERD-HRQL) (postoperatively). In more than 90% of the patients, typical symptoms (regurgitation and pyrozis) were controlled postoperatively (p < 0.001). In the first postoperative month, however, dysphagia (early dysphagia) was seen in 46 (76%) patients, whereas in the sixth postoperative month (late dysphagia) its incidence decreased to only 2 (3.3%) patients. Similarly, in the first postoperative month 42 (70%) patients had gas bloating, but the incidence of this symptom decreased to 26 (43.3%) patients by the sixth month (p = 0.01). The quality-of-life measurements obtained from both SF 36 and GERD-HRQL showed that quality of life of the patients improved significantly in the related domain of each item after surgery (p < 0.001). Laparoscopic Nissen fundoplication is an effective operation that controls the typical symptoms and improves the quality of life of patients, but new-onset symptoms affect postoperative well-being. For closer evaluation of the benefits of the operation, we need new questionnaires that comprehensively evaluate the symptom spectrum of GERD both preoperatively and postoperatively.

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.

Laparoscopic repair of large paraesophageal hiatus hernia: quality of life and durability

Laparoscopic repair of large paraesophageal hiatus hernias (LPOHH) is shown to be a safe and effective operation in the short term. However, its long-term durability and its effect on quality of life are less well established. This study aimed to assess the midterm outcome for laparoscopic repair of LPOHH with validated quality-of-life symptom scores and barium studies. Between January 2000 and July 2004, 49 patients (27 women) with LPOHH underwent laparoscopic repair. The median age of these patients was 68 years (range, 38-90 years). The laparoscopic repair included resection of the hernia sac, reduction of its contents, esophageal mobilization up to the aortic arch, crural repair with sutures (mesh reinforcement in 17 cases), Nissen fundoplication, and fixation of the wrap to the crura. Follow-up assessment was prospective with quality-of-life questionnaires, the Gastrointestinal Symptom Rating Scale (GSRS), the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQOL) scale, and barium studies. The presenting symptoms were pain for 21 patients, reflux for 27 patients, bleeding or anemia for 14 patients, and dysphagia for 17 patients. Five emergency operations were performed. Short esophagus was present in 24 patients. There were two conversions to open surgery. The major morbidity (atrial fibrillation, pulmonary embolism, and splenectomy) rate was 10.2%, and the minor morbidity (chest infection, jaundice, dysphagia, small pneumothorax) rate was 20.4%. Six patients were deceased of unrelated causes at the time of follow-up evaluation. Responses to the questionnaires were obtained in 31 cases (75%). Using the Wilcoxon signed rank test, the results from the questionnaires showed a statistically significant improvement (p < 0.001) in abdominal pain, reflux, and indigestion scores (GSRS) and GERD-HRQOL scores. Follow-up barium studies for 27 patients (66%) showed recurrence in 4 patients (14.8%), 2 of which were symptomatic. Laparoscopic repair of LPOHH is associated with good quality of life as well as an acceptable midterm recurrence rate.

The Split-Stomach Fundoplication After Esophagogastrectomy

Two complications associated with esophagogastrectomy are anastomotic leak and gastroesophageal reflux. We describe here a modification of an intrathoracic esophagogastrostomy using the gastric fundus to address these issues. After completion of the esophagogastrectomy, the fundus is divided to produce "wings." After the esophagogastrostomy is performed, the wings are used to form a wrap around the anastomosis. This wrap is secured to the esophagus and to the stomach. All patients undergoing the split-stomach fundoplication were compared with all patients undergoing standard esophagogastrectomies. End points were in-hospital mortality, anastomotic leak, and postoperative endoscopic dilation. All living patients were contacted and questioned about refluxlike symptoms and completed the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) symptom severity questionnaire. Twenty-six patients underwent the split-stomach fundoplication (wrap group), compared to 54 patients undergoing standard resection (no wrap group). Occurrence of end points in the wrap vs. no wrap groups were, respectively, in-hospital mortality, 3.8% vs. 7.4% (P = NS); anastomotic leak, 0% vs. 17% (P = 0.03); reflux symptoms 20% vs. 60% (P < 0.001); postoperative dilation, 40% vs. 30% (P = NS). The median total GERD-HRQL score was 5 for the wrap group vs. 14 for the no wrap group (P = 0.03). The addition of the split-stomach fundoplication to esophagogastrectomy may decrease the incidence of anastomotic leak and postoperative refluxlike symptoms.

Enteryx® Procedure for the Treatment of GERD Symptoms

Purpose: To evaluate the long term safety and effectiveness of Enteryx, an endoscopically implanted biocompatible copolymer for the treatment of gastroesophageal reflux disease (GERD) symptoms. Methods: Proton pump inhibitor (PPI)-dependent and PPI-responsive patients were part of a multicenter, FDA-mandated Post Approval Study designed to follow 300 patients for 36 months post Enteryx procedure. To date, 60 patients completed 36 months of follow-up. Exclusion criteria included esophageal varices, Barrett's esophagus, and poor candidacy for endoscopy. Primary study endpoint was reduction of PPI dose by at least 50% at 12, 24, and 36 months. Secondary objective was GERD health-related quality of life (GERD-HRQL) score assessment. Follow-up occurred at months 1, 6, 12, 24, and 36. Safety was assessed as the incidence of adverse events. Results: At 36 months post Enteryx procedure, 65.0% of patients reduced PPI use by at least 50%; 48.3% eliminated daily PPI use compared to baseline. Median GERD-HRQL heartburn score improvement at month 36 was 76.4% compared to baseline off PPI therapy prior to treatment (p < 0.0001); median GERD-HRQL regurgitation score improvement at month 36 was 80.0% (p < 0.0001). Adverse events (AEs) related to Enteryx generally occurred and resolved during the immediate post-implantation period. One mild case of dysphagia occurred around 24 months and resolved without treatment. Exact logistic regression of baseline measures (e.g., demographics, symptom severity, PPI use) showed no predictors of a treatment response at 36 months. Conclusions: At 36 months post-Enteryx® procedure, nearly two-thirds of patients had substantial reduction of PPI use, with almost one-half of patients eliminating daily PPI use. The improvement in GERD-HRQL heartburn and regurgitation scores relative to baseline persisted throughout 36 months. No significant predictive value of preimplantation variables was noted.

Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months

Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. At 12 months, PPI use was reduced > or =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL < or =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a > or =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

Nonresorbable copolymer implantation for gastroesophageal reflux disease: A randomized sham-controlled multicenter trial

This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure. In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months. The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001). Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.

The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole

BackgroundThe correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.MethodsAdult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.ResultsAmong the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.ConclusionsEthnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.

The quality of life of gastroesophageal reflux disease patients waiting for an antireflux operation

The purpose of this trial was to measure the health-related quality of life (HRQL) of gastroesophageal reflux disease (GERD) patients waiting for an antireflux operation. A total of 120 patients waiting for a laparoscopic fundoplication were sent questionnaires measuring their symptoms and quality of life. Ninety-five of the patients still needing an operation returned the questionaires and were included in the analysis. Thirty-one of 84 patients (37%) felt that the symptoms had worsened, and 51/90 (57%) were unsatisfied. Thirty percent suffered from throat or airway infections, 25% from swallowing difficulties, 48% from retrosternal pain, and 18% had asthma. The mean GERD HRQL score (0-45) was 21.7 (95% confidence interval, 19.7-23.7). Short Form-36 scores of this population were significantly worse when compared to patients with inguinal hernia or moderate asthma. Patients waiting for a fundoplication seem to have a significantly decreased health-related quality of life due to poor symptom control regardless of continuous medical treatment.

ENDOSCOPIC IMPLANTATION OF ENTERYX® FOR THE TREATMENT OF GERD

Purpose: To evaluate the safety and effectiveness of the Enteryx® procedure for the treatment of GERD symptoms in a randomized, controlled study of patients responding to and requiring daily PPIs. Methods: Multi-center, randomized, controlled trial of Enteryx with “crossover” option starting at 3 months post procedure. Sixty-four proton pump inhibitor (PPI)-dependent patients with well established GERD symptoms of heartburn and regurgitation were randomized using individually sealed envelopes into 2 groups of 32 patients. Control patients received an esopha-gogastroduodenoscopy (EGD) only. The primary endpoint was PPI usage at 3 months. Secondary endpoints included GERD health-related quality of life (GERD-HRQL) symptom score, 24 hr pH-metry, and manometry. PPI washout occurred prior to randomization and at the 3 month unblinding point. “Cross-over” qualification at 3 months was GERD-HRQL >15 off-PPIs. Results: Interim 3-month data were available for 84% (54/64) of randomized patients. Twenty-seven patients were randomly assigned to undergo the Enteryx procedure; 27 patients were randomly assigned to the control group. At 3 months, 17 (63%) patients in the Enteryx group demonstrated GERD symptom relief, as measured by a GERD-HRQL score <15 off-PPIs, compared to 22% in control arm. The median improvement in GERD symptom scores from baseline was 15 (range 7 to 23) in the Enteryx group compared to 4 (range-4 to 13) in the control group. Seventeen (63%) Enteryx patients had completely eliminated daily use of PPIs compared to 33% in the control group. Conclusions: At 3 months, patients in the Enteryx group appear more likely to achieve GERD symptom relief and completely eliminate daily PPI use compared to patients in the control group. These data are strongly supportive that the effectiveness of Enteryx in the unblinded prospective trials reported to date is not a “placebo response” at 3 months follow-up.

Laparoscopic Nissen fundoplication after failed endoscopic gastroplication.

Endoscopic techniques to treat gastroesophageal reflux have been developed and approved by the U.S. Food and Drug Administration. One of these techniques is endoscopic gastroplication with the Bard Endocinch device. Although the technique is initially effective, long-term symptom control has not yet been proved. No reports have documented the feasibility of laparoscopic fundoplication after failed endoscopic gastroplication. We report our experience. Ten patients who underwent endoscopic gastroplication subsequently had recurrent symptoms and were referred for laparoscopic antireflux surgery. Eight had typical symptoms of gastroesophageal reflux disease (GERD), whereas two had atypical symptoms. All patients had documented pathologic reflux by 24-hour pH monitoring. Preoperatively, all patients completed the GERD health-related quality of life (HRQL) symptom severity questionnaire. Nine of the 10 operations were completed laparoscopically. The one conversion was carried out because of excessive fat in the hiatal region. No patients had scarring of the esophagus or hiatal region. All patients with typical symptoms improved (decrease in total GERD-HRQL median score from 27 to 4), whereas none of the patients with atypical symptoms did. Six patients had persistent dysphagia for longer than 1 month; two required esophageal dilation. Laparoscopic Nissen fundoplication is feasible after failed endoscopic gastroplication. Symptomatic improvement is similar to that with the de novo operation. However, in some patients, dysphagia may persist longer.

Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease

The Gastroesophageal Reflux Disease—Health-Related Quality-of-Life (GERD-HRQL) scale was developed to objectively quantify symptom severity. It was compared to a “gold standard” health survey, the SF-36. Forty-three patients treated either medically or surgically for gastroesophageal reflux disease were asked to complete both the GERD-HRQL and the SF-36. They were asked the following: (1) Which questionnaire do you like best? (2) Which questionnaire was easier to understand? (3) Which questionnaire was more reflective of the problems you have with reflux disease? (4) Given the choice, which questionnaire would you rather fill out? Patients were asked to state their overall satisfaction with their present reflux symptom conditions. Multivariate analysis showed that the only significant predictor of patient satisfaction was the total GERD-HRQL score ( P <0.00001). There were differences in the SF-36 domains of physical function (88.7 vs. 65.3; P = 0.004) and general health (68 vs. 46.5; P = 0.006). There were no correlations between the total GERD-HRQL scores and the SF-36 domain scores. Fifty-nine percent of patients preferred the GERD-HRQL questionnaire, 62% felt it was easier to understand, 86% felt it was more reflective of their symptoms, and 67% said they would rather use it over the SF-36. The GERD-HRQL better assesses symptom severity for gastroesophageal reflux disease than the generic SF-36.