Antireflux surgery in patients with gastroesophageal reflux but a negative 24-hour pH study: late outcomes.

PURPOSE: Patients with gastroesophageal reflux disease often undergo a 24-hour pH test to confirm pathologic reflux before surgery. However, a negative pH test can occur in some individuals with reflux, and a case might still be made for antireflux surgery based on symptoms of reflux even in the absence of endoscopic esophagitis. The long-term outcomes in patients who underwent antireflux surgery despite negative preoperative test results were determined. METHODS: Patients were selected from a prospective database. A total of 745 patients met the inclusion criteria, which included typical esophageal reflux symptoms, absence of a large hiatus hernia, preoperative 24-hour pH study performed, endoscopy, and postoperative symptom and satisfaction follow-up available at 5 years. Patients were divided into 3 groups based on 24-hour pH study and endoscopy results: negative pH and negative endoscopy (n = 65), negative pH and positive endoscopy (n = 72), and positive pH (n = 608). The negative pH and negative endoscopy group underwent surgery based on clinical assessment and typical esophageal reflux symptoms. Baseline and follow-up outcomes at 5 years were evaluated using 0 to 10 analog scores, which assessed heartburn, dysphagia, and satisfaction with the overall outcome. Data were analyzed to compare the groups. RESULTS: The groups were well matched for demographics and preoperative symptom scores. At the median 5-year follow-up, clinical outcome scores were similar among the groups for heartburn, dysphagia, and overall satisfaction. The mean heartburn scores were 1.80 in the negative pH and negative endoscopy group, 1.88 in the negative pH and positive endoscopy group, and 1.91 in the positive pH group (P = .663). The mean satisfaction scores were high in all groups: 8.13, 7.31, and 7.72, respectively (P = .293). CONCLUSION: No difference in clinical outcome scores was observed. The negative pH and negative endoscopy group had high satisfaction scores and low heartburn and dysphagia scores. Our findings support antireflux surgery in well-selected symptomatic patients with a negative preoperative pH test.

Quality of life following repair of large hiatal hernia is not influenced by the use of mesh-Longer-term follow-up from a randomized trial.

INTRODUCTION: The use of prosthetic mesh in laparoscopic repair of large hiatus hernias remains controversial. Clinical and quality of life outcomes from a randomized controlled trial of mesh versus suture repair previously showed few differences at early follow-up. This study evaluated longer-term quality of life outcomes from that trial. METHODS: A prospective, multicentre, double blind randomized controlled trial assessed three methods of repair for large hiatus hernias: sutures-only versus absorbable mesh versus non-absorbable mesh. Quality of life was assessed using the Short-Form 36 (SF-36) questionnaire which was completed preoperatively and then at 3, 6, 12 months following surgery and annually thereafter. SF-36 outcomes were compared across the three repair techniques at longer-term follow-up (3-6 years), and to earlier baseline and 12-month outcomes. RESULTS: 126 patients were randomized; 43-suture-only, 41-absorbable mesh and 42-non-absorbable mesh. Questionnaires were completed by 118 patients preoperatively, 115 at 12 months and 98 at longer-term follow-up (median 5 years). There were no significant differences between the repair techniques for the subscale and composite scores at longer-term follow-up. The mental component score improved significantly after surgery and was sustained across follow-up for all techniques. The physical component score also improved significantly but was lower at longer-term follow-up compared to the 12-month follow up in both mesh groups. CONCLUSION: Surgical repair of large hiatus hernias provides sustained long-term improvement in quality of life. The addition of mesh does not improve quality of life. TRIAL REGISTRATION: This trial is registered with the Australia and New Zealand Clinical Trials Registry ACTRN12605000725662.

A Method for Increasing the Robustness of Stable Feature Selection for Biomarker Discovery in Molecular Medicine Developed Using Serum Small Extracellular Vesicle Associated miRNAs and the Barrett's Oesophagus Disease Spectrum.

The biomarker development field within molecular medicine remains limited by the methods that are available for building predictive models. We developed an efficient method for conservatively estimating confidence intervals for the cross validation-derived prediction errors of biomarker models. This new method was investigated for its ability to improve the capacity of our previously developed method, StaVarSel, for selecting stable biomarkers. Compared with the standard cross validation method, StaVarSel markedly improved the estimated generalisable predictive capacity of serum miRNA biomarkers for the detection of disease states that are at increased risk of progressing to oesophageal adenocarcinoma. The incorporation of our new method for conservatively estimating confidence intervals into StaVarSel resulted in the selection of less complex models with increased stability and improved or similar predictive capacities. The methods developed in this study have the potential to improve progress from biomarker discovery to biomarker driven translational research.

Randomized Trial of Laparoscopic Nissen Versus Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15 to 20 years.

OBJECTIVE: To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication. SUMMARY BACKGROUND DATA: Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fundoplications have been proposed. Previously reports from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures. METHODS: One hundred seven participants were randomized to Nissen versus anterior 180-degree partial fundoplication. Fifteen to 20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0 to 10 analog scores and yes/no questions to determine reflux symptoms, side-effects, and satisfaction with surgery. RESULTS: After anterior fundoplication heartburn (mean score 3.2 vs 1.4, P = .001) and proton pump inhibitor use (41.7% vs 17.1%, P = .023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, P = .015), and better ability to belch (84.2% vs 65.9%, P = .030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, P = .444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision after anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision after Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1). CONCLUSIONS: At 15 to 20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control versus more side-effects after Nissen fundoplication.

Routine Esophagograms After Hiatus Hernia Repair Minimizes Reoperative Morbidity: A Multicenter Comparative Cohort Study.

OBJECTIVE: Determine the utility of routine esophagograms after hiatus hernia repair and its impact on patient outcomes. BACKGROUND: Hiatus hernia repairs are common. Early complications such asre-herniation, esophageal obstruction and perforation, although infrequent, incur significant morbidity. Whether routine postoperative esophagograms enable early recognition of these complications, expedite surgical management, reduce reoperative morbidity, and improve functional outcomes are unclear. METHODS: Analysis of a prospectively-maintained database of hiatus hernia repairs in 14 hospitals, and review of esophagograms in this cohort. Results: A total of 1829 hiatus hernias were repaired. Of these, 1571 (85.9%) patients underwent a postoperative esophagogram. Overall, 1 in 48 esophagograms resulted in an early (<14 days) reoperation, which was undertaken in 44 (2.4%) patients. Compared to those without an esophagogram, patients who received this test before reoperation (n = 37) had a shorter time to diagnosis (2.4 vs 3.9 days, P = 0.041) and treatment (2.4 vs 4.3 days, P = 0.037) of their complications. This was associated with lower rates of open surgery (10.8% vs 42.9%, P = 0.034), gastric resection (0.0% vs 28.6%, P = 0.022), postoperative morbidity (13.5% vs 85.7%, P < 0.001), unplanned intensive care admission (16.2% vs 85.7%, P < 0.001), and decreased length-of-stay (7.3 vs 18.3 days, P = 0.009). Furthermore, we identified less intraoperative and postoperative complications, and superior functional outcomes at 1-year follow-up in patients who underwent early reoperations for an esophagogram-detected asymptomatic re-herniation than those who needed surgery for late symptomatic recurrences. CONCLUSIONS: Postoperative esophagograms decrease the morbidity associated with early and late reoperations, and should be considered for routine use after hiatus hernia surgery.

Partial Fundoplication is Effective Treatment for Female Patients with Gastroesophageal Reflux and Scleroderma: A Multicenter Comparative Cohort Study.

BACKGROUND: Patients with scleroderma often suffer from dysphagia and gastroesophageal reflux disease (GERD). Partial fundoplication is a validated anti-reflux procedure for GERD but may worsen dysphagia in scleroderma patients. Its utility in these patients is unknown. Here, we evaluate the efficacy and acceptability of partial fundoplication for the treatment of medically refractory GERD in patients with scleroderma. METHODS: Analysis of a prospectively maintained database of patients who underwent fundoplication across 14 hospitals between 1991 and 2019. Perioperative outcomes, reintervention rates, heartburn, dysphagia, and patient satisfaction were assessed at 3 months, 1- and 3-years post-surgery. RESULTS: A total of 17 patients with scleroderma were propensity score matched to 526 non-scleroderma controls. All underwent a partial fundoplication. Perioperative outcomes including complication rate, length of stay, and need for reoperation were similar between the two groups. Compared to baseline, both groups reported significantly improved heartburn at 3 months, 1- and 3-years following partial fundoplication. Surgery was equally effective at controlling heartburn across all follow-up timepoints in patients with or without scleroderma. Dysphagia to solids was more common in patients with scleroderma than controls at 3-months post-surgery, but was not significantly different to controls at 1- and 3-year follow-up. Satisfaction scores were high and comparable between both groups across all postoperative timepoints, with 100% of patients with scleroderma reporting that their initial choice to undergo surgery was correct. CONCLUSIONS: Partial fundoplication controls reflux and is associated with a transient period of dysphagia to solids in patients with scleroderma. This approach is safe, effective and acceptable for patients with scleroderma and medically refractory GERD.

Laparoscopic Fundoplication Is Effective Treatment for Patients with Gastroesophageal Reflux and Absent Esophageal Contractility.

BACKGROUND: Anti-reflux surgery in the setting of preoperative esophageal dysmotility is contentious due to fear of persistent long-term dysphagia, particularly in individuals with an aperistaltic esophagus (absent esophageal contractility). This study determined the long-term postoperative outcomes following fundoplication in patients with absent esophageal contractility versus normal motility. METHODS: A prospective database was used to identify all (40) patients with absent esophageal contractility who subsequently underwent fundoplication (36 anterior partial, 4 Nissen). Cases were propensity matched based on age, gender, and fundoplication type with another 708 patients who all had normal motility. Groups were assessed using prospective symptom assessment questionnaires to assess heartburn, dysphagia for solids and liquids, regurgitation, and satisfaction with surgery, and outcomes were compared. RESULTS: Across follow-up to 10 years, no significant differences were found between the two groups for any of the assessed postoperative symptoms. Multivariate analysis found that patients with absent contractility had worse preoperative dysphagia (adjusted mean difference 1.09, p = 0.048), but postoperatively there were no significant differences in dysphagia scores at 5- and 10-year follow-up. No differences in overall patient satisfaction were identified across the follow-up period. CONCLUSION: Laparoscopic partial fundoplication in patients with absent esophageal contractility achieves acceptable symptom control without significantly worse dysphagia compared with patients with normal contractility. Patients with absent contractility should still be considered for surgery.

Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.

OBJECTIVE: To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair. SUMMARY OF BACKGROUND DATA: Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair. METHODS: Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years. RESULTS: 126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh. CONCLUSIONS: No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.

Serum outperforms plasma in small extracellular vesicle microRNA biomarker studies of adenocarcinoma of the esophagus.

BACKGROUND: Circulating microRNAs (miRNAs) are potential biomarkers for many diseases. However, they can originate from non-disease specific sources, such as blood cells, and compromise the investigations for miRNA biomarkers. While small extracellular vesicles (sEVs) have been suggested to provide a purer source of circulating miRNAs for biomarkers discovery, the most suitable blood sample for sEV miRNA biomarker studies has not been defined. AIM: To compare the miRNA profiles between matched serum and plasma sEV preparations to determine their suitability for biomarker studies. METHODS: Matched serum and plasma samples were obtained from 10 healthy controls and 10 patients with esophageal adenocarcinoma. sEV isolates were prepared from serum and plasma using ExoQuickTM and quantified using NanoSight. RNA was extracted from sEV preparations with the miRNeasy Serum/Plasma kit and profiled using the Taqman Openarray qPCR. The overall miRNA content and the expression of specific miRNAs of reported vesicular and non-vesicular origins were compared between serum and plasma sEV preparations. The diagnostic performance of a previously identified multi-miRNA biomarker panel for esophageal adenocarcinoma was also compared. RESULTS: The overall miRNA content was higher in plasma sEV preparations (480 miRNAs) and contained 97.5% of the miRNAs found in the serum sEV preparations (412 miRNAs).The expression of commonly expressed miRNAs was highly correlated (Spearman's R = 0.87, P < 0.0001) between the plasma and serum sEV preparations, but was consistently higher in the plasma sEV preparations. Specific blood-cell miRNAs (hsa-miR-223-3p, hsa-miR-451a, miR-19b-3p, hsa-miR-17-5p, hsa-miR-30b-5p, hsa-miR-106a-5p, hsa-miR-150-5p and hsa-miR-92a-3p) were expressed at 2.7 to 9.6 fold higher levels in the plasma sEV preparations compared to serum sEV preparations (P < 0.05). In plasma sEV preparations, the percentage of protein-associated miRNAs expressed at relatively higher levels (Ct 20-25) was greater than serum sEV preparations (50% vs 31%). While the percentage of vesicle-associated miRNAs expressed at relatively higher levels was greater in the serum sEV preparations than plasma sEV preparations (70% vs 44%). A 5-miRNA biomarker panel produced a higher cross validated accuracy for discriminating patients with esophageal adenocarcinoma from healthy controls using serum sEV preparations compared with plasma sEV preparations (AUROC 0.80 vs 0.54, P < 0.05). CONCLUSION: Although plasma sEV preparations contained more miRNAs than serum sEV preparations, they also contained more miRNAs from non-vesicle origins. Serum appears to be more suitable than plasma for sEV miRNAs biomarkers studies.

Long-Term Outcomes Following Laparoscopic Repair of Large Hiatus Hernias Performed by Trainees Versus Consultant Surgeons.

BACKGROUND: The laparoscopic approach is the preferred method for repair of large hiatus hernias but can be technically challenging. Training surgeons need experience as the primary operator to gain competency in this operation. However, learning the procedure should not compromise the functional long-term outcome for patients. The aim of this study was to determine whether any difference in long-term outcomes exists for patients having a laparoscopic large hiatus hernia repair performed by a trainee versus a consultant surgeon. METHODS: A total of 648 suitable patients who had undergone laparoscopic repair of a large hiatus hernia were identified from a prospective database. Cases were divided into two groups based on whether the primary operator was a trainee or a consultant surgeon. Demographics, perioperative data, revisions and patient-reported clinical outcomes via standardised questionnaires were compared. RESULTS: There were no statistically significant differences in the clinical outcomes for patients undergoing laparoscopic repair of a large hiatus hernia performed by a trainee versus a consultant surgeon, with comparable patient-reported outcomes for heartburn, dysphagia, and overall satisfaction with the outcome following surgery. Median operative time was approximately 20 min longer for trainees (p = <0.0001). Revisional surgery rates were similar for the two groups. CONCLUSIONS: Patients operated on by trainees have equivalent long-term clinical outcomes to patients operated on by consultant surgeons. For these patients, surgery can be safely performed by supervised trainees.

Identification of microRNA Biomarkers of Response to Neoadjuvant Chemoradiotherapy in Esophageal Adenocarcinoma Using Next Generation Sequencing.

BACKGROUND: Clinical trials report improved overall survival following neoadjuvant chemoradiotherapy in patients undergoing surgery for esophageal adenocarcinoma, with a 10-15% survival improvement. MicroRNAs (miRNAs) are small noncoding RNAs that are known to direct the behavior of cancers, including response to treatment. We investigated the ability of miRNAs to predict outcomes after neoadjuvant chemoradiotherapy. METHODS: Endoscopic biopsies from esophageal adenocarcinomas were obtained before neoadjuvant chemoradiotherapy and esophagectomy. miRNA levels were measured in the biopsies using next generation sequencing and compared with pathological response in the surgical resection, and subsequent survival. miRNA ratios that predicted pathological response were identified by Lasso regression and leave-one-out cross-validation. Association between miRNA ratio candidates and relapse-free survival was assessed using Kaplan-Meier analysis. Cox regression and Harrell's C analyses were performed to assess the predictive performance of the miRNAs. RESULTS: Two miRNA ratios (miR-4521/miR-340-5p and miR-101-3p/miR-451a) that predicted the pathological response to neoadjuvant chemoradiotherapy were found to be associated with relapse-free survival. Pretreatment expression of these two miRNA ratios, pretreatment tumor differentiation, posttreatment AJCC histopathological tumor regression grading, and posttreatment tumor clearance/margins were significant factors associated with survival in Cox regression analysis. Multivariate analysis of the two ratios together with pretherapy factors resulted in a risk prediction accuracy of 85% (Harrell's C), which was comparable with the prediction accuracy of the AJCC treatment response grading (77%). CONCLUSIONS: miRNA-ratio biomarkers identified using next generation sequencing can be used to predict disease free survival following neoadjuvant chemoradiotherapy and esophagectomy in patients with esophageal adenocarcinoma.

Measuring Outcomes of Laparoscopic Anti-reflux Surgery: Quality of Life Versus Symptom Scores?

INTRODUCTION: Outcome following fundoplication for gastroesophageal reflux can be measured using objective tests, symptom scores and quality of life (QoL) measures. Which is best and how these assessments correlate is uncertain. To determine the utility of assessment measures we compared a general QoL measure (SF-36) and a disease-specific measure (GERD-hr-QoL) with symptom and satisfaction scores in individuals following fundoplication. METHODS: 329 individuals underwent fundoplication between 2000 and 2015 in 2 centres in Australia and the Netherlands. Patients were assessed before and 3, 12 and 24 months after surgery using 10-point Likert scales to assess heartburn and satisfaction, the SF-36 questionnaire and the GERD-hr-QoL questionnaire. SF-36 scores were converted into component scores: Physical Component Scale (PCS) score and Mental Component Scale (MCS) score. Correlations between QoL measures and clinical outcomes were determined. RESULTS: Surgery relieved heartburn (7.0 vs. 0.0 median, P < 0.001) and patients were highly satisfied with the outcome (median 9.0). PCS and MCS scores improved after surgery (PCS 40.9 vs. 46.0, P < 0.001; MCS 47.6 vs. 50.3, P = 0.027). GERD-hr-QoL scores also improved after surgery (15.7 vs. 3.7, P < 0.001). Correlations between PCS and MCS scores versus heartburn and satisfaction scores were generally weak or absent. However, correlations between GERD-hr-QoL versus heartburn and satisfaction scores were moderate to strong. CONCLUSION: Despite improvements in scores, the SF-36 correlated poorly with clinical outcome measures, and its use to measure outcome following fundoplication is questioned. However, the GERD-hr-QoL correlated well with the symptom scores, suggesting this disease-specific QoL measure is a better tool for assessing anti-reflux surgery outcome.

Circulating Serum Exosomal miRNAs As Potential Biomarkers for Esophageal Adenocarcinoma.

BACKGROUND: The poor prognosis and rising incidence of esophageal adenocarcinoma highlight the need for improved detection methods. The potential for circulating microRNAs (miRNAs) as biomarkers in other cancers has been shown, but circulating miRNAs have not been well characterized in esophageal adenocarcinoma. We investigated whether circulating exosomal miRNAs have potential to discriminate individuals with esophageal adenocarcinoma from healthy controls and non-dysplastic Barrett's esophagus. METHODS: Seven hundred fifty-eight miRNAs were profiled in serum circulating exosomes from a cohort of 19 healthy controls, 10 individuals with Barrett's esophagus, and 18 individuals with locally advanced esophageal adenocarcinoma. MiRNA expression was assessed using all possible permutations of miRNA ratios per individual. Four hundred eight miRNA ratios were differentially expressed in individuals with cancer compared to controls and Barrett's esophagus (Mann-Whitney U test, P < 0.05). The 179/408 ratios discriminated esophageal adenocarcinoma from healthy controls and Barrett's esophagus (linear regression, P < 0.05; area under receiver operating characteristic (ROC) > 0.7, P < 0.05). A multi-biomarker panel (RNU6-1/miR-16-5p, miR-25-3p/miR-320a, let-7e-5p/miR-15b-5p, miR-30a-5p/miR-324-5p, miR-17-5p/miR-194-5p) demonstrated enhanced specificity and sensitivity (area under ROC = 0.99, 95% CI 0.96-1.0) over single miRNA ratios to distinguish esophageal adenocarcinoma from controls and Barrett's esophagus. CONCLUSIONS: This study highlights the potential for serum exosomal miRNAs as biomarkers for the detection of esophageal adenocarcinoma.

Outcome for Asymptomatic Recurrence Following Laparoscopic Repair of Very Large Hiatus Hernia.

BACKGROUND: Radiological follow-up following repair of large hiatus hernias have identified recurrence rates of 20-30%, although most are small and asymptomatic. Whether patients will eventually develop clinical problems is uncertain. This study evaluated the outcome for individuals identified with an asymptomatic hiatus hernia following previous repair vs. asymptomatic controls. METHODS: One hundred fifteen asymptomatic patients who had previously undergone sutured repair of a large hiatus hernia and then underwent barium meal X-ray 6-60 months after surgery within a clinical trial were identified and divided into two cohorts: with (n = 41) vs. without (n = 74) an asymptomatic hernia. Heartburn, dysphagia, and satisfaction with surgery were assessed prospectively using a standardized questionnaire applying analogue scales. Consumption of antisecretory medication and revision surgery were also determined. To determine the natural history of asymptomatic recurrent hiatus hernia, outcomes for the two groups were compared at 1 and 5 years and at most recent (late) follow-up. RESULTS: Outcomes were available at 1 year for 98.2% and 5 years or the latest follow-up (range 6-237 months) for 100%. Heartburn and dysphagia scores were low and satisfaction scores high in both groups at all follow-up points, but heartburn scores and medication use were higher in the recurrent hernia group. At late follow-up, 94.6% of the recurrent hernia group vs. 98.5% without a hernia regarded their original decision for surgery to be correct. Two patients in recurrent hernia group underwent revision surgery. CONCLUSIONS: Patients with an initially asymptomatic recurrent hiatus hernia are more likely to report heartburn and use antisecretory medication at later follow-up than controls. However, overall clinical outcomes remain good, with high satisfaction and low surgical revision rates. Additional interventions to reduce the risk of recurrence might not be warranted.

Quality of Life Following Repair of Large Hiatal Hernia is Improved but not Influenced by Use of Mesh: Results From a Randomized Controlled Trial.

INTRODUCTION: Laparoscopic surgery is the treatment of choice for repair of large hiatus hernia, but can be followed by recurrence. Repair with prosthetic mesh has been recommended to prevent recurrence, although complications following mesh repair have generated disagreement about whether or not mesh should be used. The early objective and clinical results of a randomized trial of repair with mesh versus sutures have been reported, and revealed few differences. In the current study, we evaluated quality of life outcomes within this trial at follow-up to 2 years. METHODS: In a multicenter prospective double-blind randomized trial three methods for repair of large hiatus hernia were compared: sutures versus repair with absorbable mesh (Surgisis) versus non-absorbable (Timesh). Quality of life assessment using the Short-Form 36 (SF-36) questionnaire was undertaken at 3, 6, 12 and 24 months after surgery. SF-36 outcomes (8 individual scales and 2 composite scales) were determined for each group, and compared between groups, and across different follow-up points. RESULTS: 126 patients were enrolled-43 sutures, 41 absorbable mesh and 42 non-absorbable mesh. 115 (91.3%) completed a preoperative questionnaire, and 113 (89.7%) completed the post-operative questionnaire at 3 months, 116 (92.1%) at 6 months, 114 (90.5%) at 12 months, and 91 (72.2%) at 24 months. The SF-36 Physical and Mental Component Scores (PCS and MCS) improved significantly following surgery, and this improvement was sustained across 24 months follow-up (p < 0.001 for PCS and MCS at each follow-up point). There were no significant differences between the groups for the component scores or the eight SF-36 subscale scores at each follow-up time. 29 individuals had a recurrence at 6 months follow-up, of which 9 were symptomatic. The PCS were higher in patients with recurrence versus without (p < 0.01), and in patients with a symptomatic recurrence versus asymptomatic recurrence versus no recurrence (p = 0.001). CONCLUSION: SF-36 measured quality of life improved significantly after repair of large hiatal hernia at up to 2 years follow-up, and there were no differences in outcome for the different repair techniques. The use of mesh versus no mesh in repair of large hiatal hernia did not influence quality of life.

Laparoscopic antireflux surgery in patients with throat symptoms: a word of caution.

BACKGROUND: A subset of patients undergoing laparoscopic fundoplication presents with atypical throat symptoms, and the benefit of surgery in these patients is debated. These patients can present with throat symptoms alone or in combination with typical reflux symptoms. We evaluated the clinical outcome in these patients and compared their outcomes with a larger group of patients who did not have throat symptoms before fundoplication. METHODS: Outcome data for 893 consecutive patients who underwent a laparoscopic fundoplication from January 2002 to June 2008 were collected prospectively and managed on a database. Ninety-three patients with atypical throat symptoms were identified, and divided into subgroups with (n=66) and without (n=27) typical reflux symptoms (heartburn and/or regurgitation), and outcomes were compared with patients (n=800) who didn't have throat symptoms. Symptoms were assessed with analog symptom scores for heartburn and dysphagia, as well as satisfaction with the surgical outcome. Case records for patients with throat symptoms were also reviewed to obtain more detail about specific throat symptoms and their resolution. RESULTS: Cough was the commonest atypical symptom, followed by sore throat. Heartburn scores improved following surgery in all patient groups. Dysphagia was more common 3 months after surgery in patients without throat symptoms, although there were no differences for dysphagia at later follow-up. Following surgery satisfaction scores were highest in patients with atypical throat symptoms who also had typical reflux symptoms, and the scores were lowest in patients who only had atypical throat symptoms. Nearly twice as many patients who had throat and reflux symptoms reported improvement or resolution of symptoms, compared to patients who only had throat symptoms. CONCLUSIONS: Fundoplication achieves a good outcome in patients with atypical throat symptoms who also report typical symptoms of reflux. However, surgeons should be cautious about operating on the subgroup of patients with objective evidence of gastroesophageal reflux who describe throat symptoms but do not report heartburn or regurgitation. In this subgroup, expectations of a good outcome should be minimized.

Accuracy of identification of tissue types in endoscopic esophageal mucosal biopsies used for molecular biology studies.

OBJECTIVES: To determine if histopathologic assessment of esophageal biopsies harvested for research study is justified due to the heterogeneity of tissues in the esophagus, and the consequent histopathologic mis-matches with the clinical histopathology of biopsies taken at the same level. METHODS: Since 2004, patients undergoing upper endoscopy for a variety of clinical conditions were invited to provide additional esophageal biopsies; those were collected for research purpose at the same level as biopsies collected for clinical histopathology. Research biopsies were cut in two parts: one part was submitted to research histopathology and the other stored for molecular analysis. Results of clinical histopathology for each patient were summarized per biopsy level and compared to results obtained from research biopsies at the corresponding level. RESULTS: A total of 377 level summaries were obtained from 137 patients. Clinical histopathology summaries classified 123 levels (32.6%) as squamous epithelium, 84 levels (22.3%) as metaplastic columnar-lined epithelium, 135 levels (35.8%) as columnar-lined epithelium with intestinal metaplasia, 30 levels (8%) as dysplasia, and 5 levels (1.3%) as adenocarcinoma. Research histopathology matched to clinical summaries on 120 of 123 (97.5%) levels for squamous epithelium, 52 of 84 (61.9%) for metaplastic columnar-lined epithelium, and 94 of 135 (69.5%) for columnar-lined epithelium with intestinal metaplasia. There were no matches for dysplasia between the groups; however, they agreed on all five cases of AC. On 59 (70.2%) metaplastic columnar-lined epithelium levels and on 62 (46%) columnar-lined epithelium with intestinal metaplasia levels, tissue heterogeneity was observed in clinical histopathology, with portions of squamous epithelium within the samples. Matches with pure tissue samples in both clinical and research histopathology levels were observed on 22 (26.2%) levels of metaplastic columnar-lined epithelium and in 55 (40.7%) levels of columnar-lined epithelium with intestinal metaplasia. CONCLUSIONS: The high proportion of mismatches and tissue heterogeneity observed, especially among columnar-lined epithelium with intestinal metaplasia and dysplasia, points to the necessity of determining the histopathology of the research samples to avoid sampling errors during molecular studies.