Randomized clinical trial comparing laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh.

BACKGROUND: Current literature is characterized by a discrepancy between reported symptomatic and radiological recurrent hiatal hernia's following primary repair. Crural augmentation using mesh is suggested to reduce recurrence rates. The aim of this trial is to analyze 1-year outcome of laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh. METHODS: Between 2013 and 2016, 72 patients with an objectified hiatal hernia were randomized for primary repair using non-absorbable sutures and sutures reinforced with non-absorbable mesh. Data regarding the incidence of recurrent hiatal hernia, need for endoscopic dilatation or surgical reintervention, postoperative dysphagia and/or reflux symptoms, general health, and use of acid-suppressing medication were analyzed. RESULTS: 72 patients (n = 36 vs. n = 36) were included. One year after primary repair and repair using non-absorbable mesh, there were no differences in the number of recurrent hiatal hernia's demonstrated by barium swallow radiology (n = 4 [11.4%] vs. n = 6 [19.4%], p = 0.370) or upper gastrointestinal endoscopy (n = 5 [14.4%] vs. n = 5 [17.2%], p = 0.746), the number of surgical reinterventions (n = 2 [5.6%] vs. n = 1 [2.8%], p = 1.000), nor in chest pain and heartburn scores, with comparable dysphagia and satisfaction scores. Compared to the preoperative state, both groups demonstrated a comparable and significant reduction in chest pain score and Dakkak dysphagia score. CONCLUSIONS: Use of non-absorbable mesh to reinforce primary hiatal hernia repair results in equal hiatal hernia recurrence and symptomatic outcome compared to repair using sutures alone. During 1-year follow-up, there were no mesh-related complications. Follow-up beyond 1 year needs to demonstrate whether these findings are sustained.

Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and Conventional Nissen Fundoplication: A Plea for Patient Counseling and Clarification.

OBJECTIVE: To analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD). BACKGROUND: LNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling. METHODS: Between 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported. RESULTS: A total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047). CONCLUSIONS: The effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.

Systematic review and meta-analysis of randomized clinical trials (RCTs) comparing topical calcineurin inhibitors with topical corticosteroids for atopic dermatitis: A 15-year experience.

BACKGROUND: Calcineurin inhibitors are alternatives to corticosteroid for treatment of atopic dermatitis. OBJECTIVES: We sought to compare the beneficial effects and adverse events associated with these therapies in treating patients with atopic dermatitis. METHODS: Four databases were searched for randomized clinical trials comparing topical calcineurin inhibitors versus corticosteroids in children and adults. Methodological quality was evaluated to assess bias risk. Clinical outcome and costs were compared. RESULTS: Twelve independent randomized clinical trials comparing calcineurin inhibitors (n = 3492) versus corticosteroids (n = 3462) were identified. Calcineurin inhibitors and corticosteroids had similar rates of improvement of dermatitis (81% vs 71%; risk ratio [RR] 1.18; 95% confidence interval [CI] 1.04-1.34; P = .01) and treatment success (72% vs 68%; RR 1.15; 95% CI 1.00-1.31; P = .04). Calcineurin inhibitors were associated with higher costs and had more adverse events (74% vs 64%; RR 1.28; 95% CI 1.05-1.58; P = .02) including a higher rate of skin burning (30% vs 9%; RR 3.27; 95% CI 2.48-4.31; P < .00001) and pruritus (12% vs 8%; RR 1.49; 95% CI 1.24-1.79; P < .00001). There were no differences in atrophy, skin infections, or adverse events that were serious or required discontinuation of therapy. LIMITATIONS: Only a small number of trials reported costs. CONCLUSION: Calcineurin inhibitors and corticosteroids have similar efficacy. Calcineurin inhibitors are associated with higher costs and have more adverse events, such as skin burning and pruritus. These results provide level-1a support for the use of corticosteroids as the therapy of choice for atopic dermatitis.

A systematic review of surgical skills transfer after simulation-based training: laparoscopic cholecystectomy and endoscopy.

OBJECTIVE: A systematic review to determine whether skills acquired through simulation-based training transfer to the operating room for the procedures of laparoscopic cholecystectomy and endoscopy. BACKGROUND: Simulation-based training assumes that skills are directly transferable to the operation room, but only a few studies have investigated the effect of simulation-based training on surgical performance. METHODS: A systematic search strategy that was used in 2006 was updated to retrieve relevant studies. Inclusion of articles was determined using a predetermined protocol, independent assessment by 2 reviewers, and a final consensus decision. RESULTS: Seventeen randomized controlled trials and 3 nonrandomized comparative studies were included in this review. In most cases, simulation-based training was in addition to patient-based training programs. Only 2 studies directly compared simulation-based training in isolation with patient-based training. For laparoscopic cholecystectomy (n = 10 studies) and endoscopy (n = 10 studies), participants who reached simulation-based skills proficiency before undergoing patient-based assessment performed with higher global assessment scores and fewer errors in the operating room than their counterparts who did not receive simulation training. Not all parameters measured were improved. Two of the endoscopic studies compared simulation-based training in isolation with patient-based training with different results: for sigmoidoscopy, patient-based training was more effective, whereas for colonoscopy, simulation-based training was equally effective. CONCLUSIONS: Skills acquired by simulation-based training seem to be transferable to the operative setting for laparoscopic cholecystectomy and endoscopy. Future research will strengthen these conclusions by evaluating predetermined competency levels on the same simulators and using objective validated global rating scales to measure operative performance.

Laparoscopic anterior 180-degree versus nissen fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To compare short- and long-term outcome after 180-degree laparoscopic anterior fundoplication (180-degree LAF) with laparoscopic Nissen fundoplication (LNF). SUMMARY OF BACKGROUND DATA: LNF is currently the most frequently performed surgical therapy for gastroesophageal reflux disease. Alternatively, 180-degree LAF has been alleged to reduce troublesome dysphagia and gas-related symptoms, with similar reflux control. METHODS: MEDLINE, EMBASE, Cochrane Library, and web of Knowledge CPCI-S were searched for randomized clinical trials comparing primary 180-degree LAF with LNF. The methodological quality was evaluated to assess bias risk. Primary outcomes were esophageal acid exposure, esophagitis, heartburn score, dilatation for dysphagia, modified Dakkak dysphagia score (0-45), and reoperation rate. Meta-analysis was conducted at 1 and 5 years. RESULTS: Five distinct randomized clinical trials comparing 180-degree LAF (n = 227) with LNF (n = 231) were identified. At 1 year, the Dakkak dysphagia score [2.8 vs 4.8; weighted mean difference: -2.25; 95% confidence interval (CI): -2.66 to -1.83; P < 0.001], gas bloating [11% vs 18%; relative risk (RR) 0.59; 95% CI: 0.36-0.97; P = 0.04], flatulence (14% vs 25%; RR: 0.57; 95% CI: 0.35-0.91; P = 0.02), inability to belch (19% vs 31%; RR: 0.63; 95% CI: 0.40-0.99; P = 0.05), and inability to relieve bloating (34% vs 44%; RR: 0.74; 95% CI: 0.55-0.99; P = 0.04) were lower after 180-degree LAF. Esophageal acid exposure (standardized mean difference: 0.19; 95% CI: -0.07 to 0.46; P = 0.15), esophagitis (19% vs 13%; RR: 1.42; 95% CI: 0.69-2.91; P = 0.34), heartburn score (standardized mean difference: 1.27; 95% CI:-0.36 to 2.90; P = 0.13), dilatation rate (1.4% vs 2.8%; RR: 0.60; 95% CI: 0.19-1.91; P = 0.39), reoperation rate (5.7% vs 2.8%; RR: 2.08; 95% CI: 0.80-5.41; P = 0.13), perioperative outcome, regurgitation, proton pump inhibitor (PPI) use, lower esophageal sphincter pressure, and patient satisfaction were similar after 180-degree LAF and LNF. At 5 years, the Dakkak dysphagia score, flatulence, inability to belch, and inability to relieve bloating remained lower after 180-degree LAF. The 5-year heartburn score, dilatation rate, reoperation rate, PPI use, and patient satisfaction were similar. CONCLUSIONS: At 1 and 5 years, dysphagia and gas-related symptoms are lower after 180-degree LAF than after LNF, and esophageal acid exposure and esophagitis are similar, with no differences in heartburn scores, patient satisfaction, dilatations, and reoperation rate. These results lend level 1a support for the use of 180-degree LAF for the surgical treatment of gastroesophageal reflux disease.

Objective outcomes 14 years after laparoscopic anterior 180-degree partial versus nissen fundoplication: results from a randomized trial.

OBJECTIVE: To investigate late objective outcomes 14 years after laparoscopic anterior 180-degree partial versus Nissen fundoplication. BACKGROUND: Clinical outcomes from randomized clinical trials suggest good outcomes for anterior 180-degree partial fundoplication, with similar control of reflux symptoms and less side effects, compared with Nissen fundoplication. However, objective outcomes at late follow-up have not been reported. METHODS: A subset of participants from a randomized trial of anterior 180-degree versus Nissen fundoplication underwent stationary esophageal high-resolution manometry and ambulatory 24-hour impedance-pH monitoring at 14 years' follow-up. The subset and other patients in the trial also completed a standardized clinical questionnaire to ensure that they were representative of the overall trial. RESULTS: Eighteen patients (8 anterior, 10 Nissen) underwent objective testing and had a symptom profile similar to those who did not (n = 59) have testing. Total esophageal acid exposure time and the total number of acid and weakly acidic reflux episodes per 24 hours were higher after anterior fundoplication than after Nissen fundoplication. Proximal, midesophageal and distal reflux were proportionately increased after anterior 180-degree fundoplication. The number of liquid and mixed reflux episodes was also higher after anterior fundoplication, which was accompanied by higher clinical heartburn scores. There were no differences in gas reflux, gastric belches, and supragastric belches, which is in line with the observation that gas-related symptoms were similar for both groups. Mean LES resting and relaxation nadir pressure were lower after anterior fundoplication, which was reflected by lower dysphagia scores. Patient satisfaction was similar after both procedures. CONCLUSIONS: At 14 years after randomization, this study demonstrated that acid, weakly acidic, liquid and mixed reflux episodes are more common after anterior 180-degree fundoplication than after Nissen fundoplication. On the contrary, gas reflux and gastric belching and patient satisfaction are similar for both procedures. Mean LES resting and relaxation nadir pressure are lower after anterior fundoplication. Overall, these findings suggest less effective reflux control after anterior 180-degree partial fundoplication, offset by less dysphagia, leading to a clinical outcome that is equivalent to Nissen fundoplication at late follow-up.

Gas-related symptoms after antireflux surgery.

BACKGROUND: Gas-related symptoms such as bloating, flatulence, and impaired ability to belch are frequent after antireflux surgery, but it is not known how these symptoms affect patient satisfaction with the procedure or what determines the severity of these complaints. We aimed to assess the impact of gas-related symptoms on patient-perceived success of surgery and to determine whether the severity of gas-related complaints after antireflux surgery is associated with objectively measured abnormalities. METHODS: Fifty-two patients were studied at a median of 27 months after antireflux surgery. The influence of gas-related symptoms on their quality of life and satisfaction with surgical outcome was assessed. The rates of air swallows and gastric and supragastric belches before and after surgery were assessed using impedance measurements. RESULTS: Bloating and flatulence were associated with a decreased quality of life and less satisfaction with surgical outcome. Notably, 9 % of the patients would not opt for surgery again due to gas-related symptoms. Antireflux surgery decreased the total number of gastric belches but did not affect the number of air swallows. The severity of gas-related symptoms was not associated with an increased number of preoperative air swallows and/or belches or a larger postoperative decrease in the number of gastric belches. CONCLUSION: Gas-related symptoms are associated with less satisfaction with surgical outcome. The severity of gas-related symptoms is not determined by the number of preoperative air swallows or a more severe impairment of the ability to belch after surgery. Preoperative predictors of postoperative gas-related symptoms therefore could not be identified.

Five-year outcome after laparoscopic anterior partial versus Nissen fundoplication: four randomized trials.

OBJECTIVE: To compare longer term (5-year) outcomes for reflux control and postsurgery side effects after laparoscopic anterior (90° and 180°) partial versus Nissen fundoplication for gastroesophageal reflux. BACKGROUND: Laparoscopic Nissen fundoplication is the most frequently performed surgical procedure for gastroesophageal reflux. It achieves excellent control of reflux, but in some patients it is followed by troublesome side effects. To reduce the risk of side effects laparoscopic anterior partial fundoplication variants have been advocated, although some studies suggest poorer reflux control. METHODS: From 1995 to 2003, 461 patients with gastroesophageal reflux were enrolled in 4 randomized controlled trials comparing anterior partial versus Nissen fundoplication. Two trials evaluated anterior 180° and 2 anterior 90° partial fundoplication. The original trial data were combined, and a reanalysis from original data was undertaken to determine outcomes at 5 years follow-up. Reflux symptom control and side effects were evaluated in a blinded fashion using standardized questionnaires, including 0 to 10 analog scores (0 = no symptoms, 10 = severe symptoms). RESULTS: At 5 years, patients who underwent an anterior 90° or 180° partial fundoplication had less side effects than those who underwent Nissen fundoplication and were equally satisfied with the overall outcome. Reflux control, measured by heartburn scores and antisecretory medication use, was similar for anterior 180° partial versus Nissen fundoplication, but inferior after anterior 90° partial versus Nissen fundoplication. CONCLUSIONS: Anterior 180° partial fundoplication achieves durable control of reflux symptoms and fewer side effects compared with Nissen fundoplication. Reflux control after anterior 90° partial fundoplication appears less effective than after Nissen fundoplication. This data supports the use of anterior 180° partial fundoplication for the surgical treatment of gastroesophageal reflux.

Reflux and belching after 270 degree versus 360 degree laparoscopic posterior fundoplication.

OBJECTIVE: To investigate differences in effects of 270 degrees (270 degrees LPF) and 360 degrees laparoscopic posterior fundoplication (360 degrees LPF) on reflux characteristics and belching. BACKGROUND: Three hundred sixty degrees LPF greatly reduces the ability of the stomach to vent ingested air by gastric belching. This frequently leads to postoperative symptoms including inability to belch, gas bloating and increased flatulence. Two hundred seventy degrees LPF allegedly provides less effective reflux control compared with 360 degrees LPF, but theoretically may allow for gastric belches (GBs) with a limitation of gas-related symptoms. METHODS: Endoscopy, stationary esophageal manometry, and 24-hour impedance-pH monitoring off PPIs was performed before and 6 months after fundoplication for PPI-refractory gastroesophageal reflux disease (n = 14 270 degrees LPF vs. n = 28 360 degrees LPF). GBs were defined as gas components of pure gas and mixed reflux episodes reaching the proximal esophagus. Absolute reductions (Δ) were compared. RESULTS: Reflux symptoms and the 24-hour incidence of acid (Δ -77.6 vs. -76.7), weakly acidic (Δ -9.4 vs. -6.6), liquid (Δ -59.0 vs. -49.8) and mixed reflux episodes (Δ -28.0 vs. -33.5) were reduced to a similar extent after 270° LPF and 360° LPF, respectively. The reduction in proximal, mid-esophageal and distal reflux episodes were similar in both groups as well. Persistent symptoms were not related to acid or weakly acidic reflux. Two hundred seventy degrees LPF had no significant impact on the number of gas reflux episodes (Δ -3.6; P = 0.363), whereas 360 degrees LPF significantly reduced gas reflux episodes (Δ -17.0; P = 0.002). After 270 degrees LPF, GBs (Δ -29.3 vs. -50.6; P = 0.026) were significantly less reduced and the prevalence of gas bloating (7.1% vs. 21.4%; P = 0.242) and increased flatulence (7.1% vs. 42.9%; P = 0.018) was lower compared to 360 degrees LPF. Twenty-eight patients (67%) showed supragastric belches (SGBs) before and after surgery. The increase in SGBs without reflux (Δ +32.4 vs. +25.5) and the decrease in reflux-associated SGBs (Δ -12.1 vs. -14.0) were similar after 270 degrees LPF and 360 degrees LPF. CONCLUSIONS: Two hundred seventy degrees LPF and 360 degrees LPF alter the belching pattern by reducing GBs (air venting from stomach) and increasing SGBs (no air venting from stomach). However, gas reflux and GBs are reduced less after 270 degrees LPF than after 360 degrees LPF, resulting in more air venting from the stomach and less gas bloating and flatulence, whereas reflux is reduced to a similar extent in the short-term.

Laparoscopic anterior versus posterior fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To compare short- and long-term outcome after laparoscopic anterior fundoplication (LAF) versus posterior fundoplication (LPF) through a systematic review and meta-analysis of randomized clinical trials (RCTs). SUMMARY OF BACKGROUND DATA: LPF is currently considered the surgical therapy of choice for gastroesophageal reflux disease (GERD). Alternatively, LAF has been alleged to reduce troublesome dysphagia and gas-related symptoms. METHODS: Four electronic databases (MEDLINE, EMBASE, Cochrane Library, and ISI web of Knowledge CPCI-S) were searched for RCTs comparing primary LAF versus LPF for GERD. The methodological quality was evaluated to assess bias risk. Primary outcomes were esophageal acid exposure time, heartburn, Dakkak dysphagia score (0-45) and reoperation rate. Short- and long-term results were pooled separately in meta-analyses as risk ratios (RRs) and weighted mean differences (WMDs). RESULTS: Eleven reports on 7 eligible RCTs (anterior vs. posterior total [n = 5]; anterior vs. posterior partial [n = 2]) comparing LAF (n = 345) versus LPF (n = 338) were identified. Short-term (6-12 months) esophageal acid exposure time (3.3% vs. 0.8%: WMD 2.04; 95% confidence interval [CI] [0.84-3.24]; P < 0.001), heartburn (21% vs. 8%; RR 2.71; 95%CI [1.72-4.26]; P < 0.001) and reoperation rate (8% vs. 4%; RR 1.94; 95%CI [0.97-3.87]; P = 0.06) were higher after LAF. In contrast, the Dakkak dysphagia score was lower after LAF (2.5 vs. 5.7; WMD -2.87; 95%CI [-3.88 to -1.87]; P < 0.001). There were no short-term differences in prevalence of esophagitis, regurgitation and perioperative outcomes. The higher rate of heartburn after LAF persisted during long-term (2-10 years) follow-up (31% vs. 14%; RR 2.15; 95% CI [1.49-3.09]; P < 0.001) with more PPI use (25% vs. 10%; RR 2.53; 95% CI [1.40-4.45]; P = 0.002). The long-term reoperation rate was twice as high after LAF (10% vs. 5%; RR 2.12; 95% CI [1.07-4.21]; P = 0.03). Long-term Dakkak dysphagia scores, inability to belch, gas bloating and satisfaction were not different. CONCLUSIONS: Esophageal acid exposure time and the prevalence of heartburn are higher after LAF compared with LPF. In the short-term this is counterbalanced by less severe dysphagia. However, dysphagia scores become similar in the long-term, with a persistent substantial increase in prevalence of heartburn and PPI use after LAF. The reoperation rate is twice as high after LAF as well, mainly due to reinterventions for recurrent GERD. The prevalence of gas-related symptoms is similar. These results lend level 1a support for the use of LPF as the surgical treatment of choice for GERD.

Ten-year outcome of laparoscopic and conventional nissen fundoplication: randomized clinical trial.

OBJECTIVE: To compare 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF), with focus on effectiveness and reoperation rate. SUMMARY OF BACKGROUND DATA: LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease (GERD). Decisions are based on equal short-term effectiveness and reduced morbidity, but confirmation by long-term level 1 evidence is lacking. METHODS: From 1997 to 1999, 177 proton pump inhibitor (PPI)-refractory GERD patients were randomized to undergo LNF or CNF. The 10 years results of surgery on reflux symptoms, general health, PPI use, and reoperation rates, are described. High-resolution manometry, 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only. RESULTS: A total of 148 patients (79 LNF, 69 CNF) participated in this 10-year follow-up study. GERD symptoms were relieved in 92.4% and 90.7% (NS) after LNF and CNF, respectively. Severity of heartburn and dysphagia were similar, but slightly more patients had relief of regurgitation after LNF (98.7% vs. 91.0%; P = 0.030). The percentage of patients using PPIs slowly increased with time in both groups to 26.6% for LNF and 22.4% for CNF (NS). General health (74.7% vs. 72.7%; NS) and quality of life (visual analogue scale score: 65.3 vs. 61.4; NS) improved similarly in both groups. The percentage of patients who would have opted for surgery again was similar as well (78.5% vs. 72.7%; NS). Twice as many patients underwent reoperation after CNF compared with LNF (12 [15.2%] vs. 24 [34.8%]; P = 0.006), including a higher number of incisional hernia corrections (2 vs. 9; P = 0.015). Mean interval between operation and reintervention was longer after CNF (22.9 vs. 50.6 months; P = 0.047). Of the patients who were dependent on daily PPI therapy at 10 years (LNF 10, CNF 10), 7 patients (LNF 3, CNF 4) had recurrent GERD on pH-impedance monitoring, 5 of them with some form of anatomic recurrence. A total of 13 of 20 (65.0%) patients did not have recurrent GERD. Fourteen patients had an abnormal high-resolution manometry. CONCLUSIONS: CNF carries a higher risk for surgical reintervention compared with LNF, mainly due to incisional hernia corrections. The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control. Consequently, the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD.

The preoperative reflux pattern as prognostic indicator for long-term outcome after Nissen fundoplication.

OBJECTIVES: We set out to investigate the impact of the preoperative reflux pattern on long-term outcome after Nissen fundoplication. Recent studies disagree on whether patients with pathological upright reflux should be discouraged from undergoing surgery. METHODS: A total of 338 patients underwent Nissen fundoplication. Of these, 234 of 289 patients had pathological acid exposure on preoperative 24-h esophageal pH monitoring and their reflux was classified as pathological upright (n=81), supine (n=55), or bipositional (n=98). Clinical outcomes and results of endoscopy, manometry, and 24-h pH monitoring were compared before surgery, and at 3 months and 5 years after surgery. RESULTS: Patients with pathological upright and supine reflux had similar preoperative reflux parameters. In patients with pathological bipositional reflux, however, preoperative total acid exposure was higher than that in patients with upright or supine reflux (18.3% vs. 10.7 and 7.5%; P<0.001 and P<0.001). Prevalence of esophagitis was higher in patients with bipositional reflux than in those with upright reflux, both before (64.0 vs. 45.6%; P=0.035) and 3 months after surgery (16.0 vs. 3.5%; P=0.018). Before surgery, mean lower esophageal sphincter (LES) pressure was lower compared with the upright and supine reflux groups (1.0 vs. 1.5 and 1.6 kPa; P=0.007 and 0.005, respectively). The increase in quality of life, reduction of symptoms, use of acid-suppressing drugs, total acid exposure, and esophagitis were independent of reflux pattern at 3 months and 5 years after surgery (all P<0.05). Prevalence of recurrent pathological acid exposure was higher in the bipositional group than in the upright group (40.9 vs. 10.7%; P=0.013). Surgical reintervention was significantly more common in bipositional reflux patients (20.0 vs. 8.9% for upright and 4.1% for supine). CONCLUSIONS: All three pathological reflux patterns respond favorably to Nissen fundoplication in the long term. Patients with pathological bipositional reflux, however, suffer from more severe disease with higher chance of recurrence and reoperation.

Bioactive versus bare platinum coils for the endovascular treatment of intracranial aneurysms: systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Bioactive coils were introduced in 2002 in an attempt to improve aneurysm healing and durability of angiographic results. Evidence demonstrating superior efficacy to justify the routine use of bioactive coils over bare coils is limited. We compared the periprocedural and clinical outcome after bioactive and bare platinum coiling for intracranial aneurysms. METHODS: MEDLINE, EMBASE, Cochrane Library, and ISI Web of Knowledge Conference Proceedings Citation Index-Science were searched for randomized clinical trials (RCTs) comparing bioactive and bare coils. The methodological quality was evaluated to assess bias risk. Periprocedural outcomes and mid-term outcomes were compared. RESULTS: Five independent RCTs comparing bioactive (n=1084) and bare coils (n=1084) were identified. Periprocedural outcome was similar for both groups. Bioactive coiling increased the rate of complete aneurysm occlusion (47% vs 40%; RR 1.17 (95% CI 1.05 to 1.31); p=0.006) and reduced the rate of residual aneurysm neck at 10 months compared with bare coiling in the mid-term (26% vs 31%; RR 0.82 (95% CI 0.70 to 0.96); p=0.01). There were no differences in aneurysm recurrence, aneurysm rupture, stroke, neurological death, modified Rankin Scale score and reinterventions. Subgroup analysis for the three RCTs on hydrogel coils demonstrated reduction of residual aneurysms compared with bare coiling (25% vs 34%; RR 0.76 (95% CI 0.58 to 0.99); p=0.04). CONCLUSIONS: Bioactive coils ensure a higher rate of medium-term complete aneurysm occlusion while reducing the rate of residual neck aneurysms compared with bare coiling in the mid-term. Hydrogel coils reduce residual aneurysms compared with bare coils. While there is level 1a evidence to show more complete aneurysm occlusion, longer term follow-up is needed to determine if this translates into clinical significance.

Impact of surgeon experience on 5-year outcome of laparoscopic Nissen fundoplication.

OBJECTIVE: To investigate the 5-year effect of surgeon experience with laparoscopic Nissen fundoplication (LNF). In 2000, a randomized controlled trial (RCT) was prematurely terminated because LNF for gastroesophageal reflux disease was associated with a higher risk to develop dysphagia than conventional Nissen fundoplication (CNF). Criticism focused on alleged bias caused by the relative lack of experience with the laparoscopic approach of the participating surgeons. DESIGN: Multicenter RCT and prospective cohort study. SETTING: University medical centers and tertiary teaching hospitals. PATIENTS: In the RCT, 74 patients underwent CNF and 93 patients underwent LNF (LNFI). The complete setup of the cohort study (LNFII) (n = 121) mirrored the RCT, except that surgeon experience increased from more than 5 to more than 30 LNFs per surgeon. INTERVENTIONS: Conventional Nissen fundoplication, LNFI, and LNFII. MAIN OUTCOME MEASURES: Intraoperative and in-hospital characteristics, objective reflux control, and clinical outcome. RESULTS: In LNFII, operating time (110 vs 165 minutes; P < .001), dysphagia (2.5% vs 12.3%; P = .008), dilatations for dysphagia (0.8% vs 7.0%; P = .02), and conversions (3.5% vs 7.7%; P = .19) were reduced compared with LNFI. Moreover, in LNFII, hospitalization (4.2 vs 5.6 days; P = .07 and 4.2 vs 7.6 days; P < .001) and in-hospital complications (5.1% vs 13.5%; P = .046 and 5.1% vs 19.3%; P = .005) were reduced compared with LNFI and CNF, respectively. In LNFII, the 6-month reintervention rate was reduced compared with LNFI (0.8% vs 10.1%; P = .002). Esophagitis and esophageal acid exposure at 3 months and reflux symptoms, proton-pump inhibitor use, and quality of life at 5 years improved similarly. CONCLUSIONS: Operating time, complications, hospitalization, early dysphagia, dilatations for dysphagia, and reintervention rate after LNF improve significantly when surgeon experience increases from more than 5 to more than 30 LNFs. In contrast, short-term objective reflux control and 5-year clinical outcome do not improve with experience. In experienced hands, LNF reduces in-hospital complications and hospitalization compared with CNF, with similar 5-year effectiveness and reoperation rate.

Symptomatic and objective results of laparoscopic Nissen fundoplication after failed EndoCinch gastroplication for gastro-oesophageal reflux disease.

BACKGROUND: Several endoscopic techniques have been introduced to treat gastro-oesophageal reflux disease, but their effectiveness varies. Subsequent laparoscopic Nissen fundoplication (LNF) might be required because of persistence or recurrence of symptoms. The aim of this study was to evaluate the outcome of LNF after previous EndoCinch gastroplication. METHODS: Eleven consecutive patients who underwent LNF after failed EndoCinch were included. Data were prospectively collected. Symptomatic outcome was obtained by validated questionnaires, and objective outcome by endoscopy, oesophageal manometry and pH monitoring. RESULTS: LNF was performed without major complications. After a median (range) follow-up of 31 (6-61) months, preoperative symptoms were resolved or improved in nine patients (81.8%), and general quality of life was significantly improved. None of the patients experienced daily complaints of heartburn postoperatively, and the median Gastro-Esophageal Reflux Disease Health Related Quality of Life score was 4 (0-9). Three patients (27.3%) had troublesome daily dysphagia. Oesophageal acid exposure was normalised after surgery in all but one patient, and another patient (9.1%) had persisting grade A oesophagitis. One patient (9.1%) underwent revisional LNF because of reflux and dysphagia caused by an intrathoracic migrated wrap. CONCLUSION: This study has shown that quality of life and reflux control were satisfactory after LNF for failed EndoCinch gastroplication. Troublesome dysphagia was more frequently present after surgery in comparison with primary LNF.