Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery: A 13-Year Follow-Up of a Randomized Clinical Trial.

Importance: Antireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed. Objective: To assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD. Design, Setting, and Participants: A double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population. Interventions: Closure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft). Main Outcomes and Measures: The primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, χ2, or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs. Results: Of 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01). Conclusions and Relevance: Findings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD. Trial Registration: ClinicalTrials.gov Identifier: NCT05069493.

[Novel endoscopic antireflux procedures - time for critical appraisal]. / Dags för kritisk bedömning av nya minimalinvasiva antirefluxtekniker.

GERD is the most prevalent gastrointestinal disorder in the Western world and the extent of anatomic alterations underlying the mechanisms of GERD can be viewed upon as a spectrum from a single anatomic alteration (e.g.  incompetent lower esophageal sphincter) to multiple anatomic alterations, such as diaphragmatic hiatal hernia. The degree of anatomic aberrations also seem to correlate with the complications of GERD. Since GERD is a heterogenous disease, it can be argued that its treatment should be individualized. The medical and surgical therapies have been the mainstay of long-term treatment of GERD, but during recent decades several Food and Drug Administration (FDA)-approved devices have become available for endoscopic treatment of GERD, thus potentially filling the alleged therapeutic gap between medication and surgery. Endoscopic treatment options are now considered appropriate treatment in particular in patients early in the GERD spectrum. However, serious methodological concerns can be raised regarding the scientific documentation behind all of these devices, despite the fact that they are vigorously marketed. This article outlines the basic principles and guidelines for the current and future documentations of such devices, which might be helpful for the clinician in selecting the most accurate long-term therapeutic alternative for patients with chronic GERD.

Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial.

BACKGROUND: Fundoplication is an essential step in para-oesophageal hernia (POH) repair, but which type minimizes postoperative mechanical complications is controversial. METHODS: This was a randomized, double-blind clinical trial conducted between May 2009 and October 2018. Patients with symptomatic POH were allocated to either a total (Nissen) or a posterior partial (Toupet) fundoplication after hernia reduction and crural repair. The primary outcome was dysphagia (Ogilvie dysphagia scores) at 6 months postoperatively. Secondary outcomes were peri- and postoperative complications, swallowing difficulties assessed by the Dakkak dysphagia score, gastro-oesophageal reflux, quality of life (QoL), and radiologically confirmed hernia recurrence. RESULTS: A total of 70 patients were randomized to a Nissen (n = 32) or a Toupet (n = 38) fundoplication. Compared with baseline, Ogilvie dysphagia scores were stable at the 3- and 6-month follow-up in the Nissen group (P = 0.075 and 0.084 respectively) but significantly improved in the Toupet group (from baseline mean (s.d.): 1.4 (1.1) to 0.5 ( 0.8) at 3 months, and 0.5 (0.6) at 6 months; P = 0.003 and P = 0.001 respectively). At 6 months, Dakkak dysphagia scores were significantly higher in the Nissen group than in the Toupet group (mean (s.d.): 10.4 (7.9) versus 5.1 (7.2); P = 0.003). QoL scores improved throughout the follow-up. However, at 3 and 6 months postoperatively, the absolute median improvement (⍙) from preoperative values in the mental component scores of the Short Form-36 QoL questionnaire was significantly higher in the Toupet group (median (i.q.r.): 7.1 (-0.6 to 15.2) versus 1.0 (-5.4 to 3.3) at 3 months, and 11.2 (1.4 to 18.3) versus 0.4 (-9.4 to 7.5) at 6 months; (P = 0.010 and 0.003 respectively)). At 6 months, radiologically confirmed POH recurrence occurred in 11 of 24 patients (46 per cent) of the Nissen group and in 15 of 32 patients (47 per cent) of the Toupet group (P = 1.001). CONCLUSIONS: A partial posterior wrap (Toupet fundoplication) showed reduced obstructive complications and improved QoL compared with a total (Nissen) fundoplication following POH repair.Registration number: NCT04436159 (http://www.clinicaltrials.gov).

Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

Importance: The efficacy of fundoplication operations in the management of gastroesophageal reflux disease (GERD) has been documented. However, few prospective, controlled series report long-term (>10 years) efficacy and postfundoplication concerns, particularly when comparing various types of fundoplication. Objective: To compare long-term (>15 years) results regarding mechanical complications, reflux control, and quality of life between patients undergoing posterior partial fundoplication (PF) or total fundoplication (TF) (270° vs 360°) in surgical treatment for GERD. Design, Setting, and Participants: A double-blind randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from November 19, 2001, to January 24, 2006. A total of 456 patients were recruited and randomized. Data for this analysis were collected from August 1, 2019, to January 31, 2021. Interventions: Laparoscopic 270° posterior PF vs 360° TF. Main Outcomes and Measures: The main outcome was dysphagia scores for solid and liquid food items after more than 15 years. Generic (36-Item Short-Form Health Survey) and disease-specific (Gastrointestinal Symptom Rating Scale) quality of life and proton pump inhibitor consumption were also assessed. Results: Among 407 available patients, relevant data were obtained from 310 (response rate, 76%; mean [SD] age, 66 [11.2] years; 184 [59%] men). A total of 159 were allocated to a PF and 151 to a TF. The mean (SD) follow-up time was 16 (1.3) years. At 15 years after surgery, mean (SD) dysphagia scores were low for both liquids (PF, 1.2 [0.5]; TF, 1.2 [0.5]; P = .58) and solids (PF, 1.3 [0.6]; TF, 1.3 [0.5]; P = .97), without statistically significant differences between the groups. Reflux symptoms were equally well controlled by the 2 types of fundoplications as were the improvements of quality-of-life scores. Conclusions and Relevance: The long-term findings of this randomized clinical trial indicate that PF and TF are equally effective for controlling GERD and quality of life in the long term. Although PF was superior in the first years after surgery in terms of less dysphagia recorded, this difference did not prevail when assessed a decade later. Trial Registration: ClinicalTrials.gov Identifier: NCT04182178.

[Management of patients with gastroesophageal reflux disease can be optimized]. / Gastroesofageal refluxsjukdom ­ gammal bekant med nya ansikten.

Gastroesophageal reflux disease (GERD) often requires lifelong treatment to return to and maintain a normal quality of life. Proton pump inhibitors (PPIs) offer effective medical treatment and can be used for a long time with good safety margins. The diagnostic criteria for GERD must be strictly based on current guidelines and the need for maintained treatment must be regularly evaluated. When medical treatment fails (> 20%), the patient should be offered a consultation with a specialist in the field. Too many patients who are currently treated with PPI for suspected GERD ultimately require treatment with a completely different diagnosis in focus. The investigation and treatment options are several and well-defined in the event of PPI failure in patients with well documented GERD. The indications for surgical treatment are well established, but this treatment option is likely underused today.

Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia.

BACKGROUND: Pneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODS: In a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux. RESULTS: A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%. CONCLUSIONS: In this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).

Comparison of Laparoscopic 270° Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial.

Importance: Restoration of the esophagogastric junction competence is critical for effective long-term treatment of gastroesophageal reflux disease. Surgical repair results in such restoration, but mechanical adverse effects seem unavoidable. Minimizing these adverse effects without jeopardizing reflux control is warranted. Objective: To determine whether partial fundoplication (PF) or total fundoplication (TF) is superior in laparoscopic antireflux surgery. Design, Setting, and Participants: In this double-blind, randomized clinical trial of 1171 patients scheduled for laparoscopic antireflux surgery at a single university-affiliated center between November 19, 2001, and January 24, 2006, 456 patients were randomized and followed up for 5 years. Data were collected from November 2001 to April 2012, and data were analyzed from April 2012 to September 2018. Interventions: A 270° posterior PF or a 360° Nissen TF. Main Outcomes and Measures: Esophageal acid exposure at 3 years after surgery. Result: Of the 456 randomized patients, 268 (58.8%) were male, and the mean (SD) age was 49.0 (11.7) years. A total of 229 patients were randomized to PF, and 227 patients were randomized to TF. At 3 years postoperatively, the median (interquartile range) esophageal acid exposure was reduced from 14.6% (9.8-21.9) to 1.8% (0.7-4.4) after PF and from 16.0% (10.4-22.7) to 2.5% (0.8-6.8) after TF (P = .31). Likewise, reflux symptoms were equally and effectively controlled. Early postoperative dysphagia (6 weeks) was common in both groups but then decreased toward normality. A small but statistically significant difference in favor of PF was noted in the mean (SD) scoring of dysphagia for liquids at 6 weeks (PF, 1.6 [0.9]; TF, 1.9 [1.3]; P = .01) and for solid food at 12 months (PF, 1.3 [1.0]; TF, 1.9 [1.4]; P < .001) and 24 months (PF, 1.3 [0.9]; TF, 1.7 [1.2]; P = .001). Quality of life was reduced before surgery but increased to normal values after surgery and remained so over 5-year follow-up, with no difference between the groups. Conclusions and Relevance: The results from this randomized clinical trial suggest that although PF and TF could be recommended for treatment of gastroesophageal reflux disease, PF might be superior by inducing less dysphagia. Trial Registration: ClinicalTrials.gov identifier: NCT03659487.

[The large hiatal hernia should be acknowledged and respected]. / Det stora hiatusbråcket ­ kräver stor uppmärksamhet och respekt - Vanligt och ofta asymtomatiskt tillstånd som snabbt kan bli potentiellt livshotande.

A hiatal hernia is a partial or total dislocation of the stomach, sometimes together with other intraabdominal organs, through the diaphragmatic esophageal hiatus into the thoracic cavity. The condition is common and often asymptomatic. Old age and obesity are risk factors for developing hiatal hernia. Small hernias might induce gastroesophageal reflux, which usually is satisfactorily treated pharmacologically. Larger hiatal hernias are more often associated with obstructive symptoms including dysphagia, vomiting or discomfort/pain due to compression of adjacent organs/tissues. In severe cases, large hiatal hernias may become incarcerated with ischemia in herniated tissues and need of acute surgical intervention. The risk of complications in association with operation for large hiatal hernias is high, particularly in acute surgery and in elderly patients with co-morbidities.

Impact of gastroesophageal reflux control through tailored proton pump inhibition therapy or fundoplication in patients with Barrett's esophagus.

AIM: To determine the impact of upwards titration of proton pump inhibition (PPI) on acid reflux, symptom scores and histology, compared to clinically successful fundoplication. METHODS: Two cohorts of long-segment Barrett's esophagus (BE) patients were studied. In group 1 (n = 24), increasing doses of PPI were administered in 8-wk intervals until acid reflux normalization. At each assessment, ambulatory 24 h pH recording, endoscopy with biopsies and symptom scoring (by a gastroesophageal reflux disease health related quality of life questionnaire, GERD/HRLQ) were performed. Group 2 (n = 30) consisted of patients with a previous fundoplication. RESULTS: In group 1, acid reflux normalized in 23 of 24 patients, resulting in improved GERD/HRQL scores (P = 0.001), which were most pronounced after the starting dose of PPI (P < 0.001). PPI treatment reached the same level of GERD/HRQL scores as after a clinically successful fundoplication (P = 0.5). Normalization of acid reflux in both groups was associated with reduction in papillary length, basal cell layer thickness, intercellular space dilatation, and acute and chronic inflammation of squamous epithelium. CONCLUSION: This study shows that acid reflux and symptom scores co-vary throughout PPI increments in long-segment BE patients, especially after the first dose of PPI, reaching the same level as after a successful fundoplication. Minor changes were found among GERD markers at the morphological level.

Per-oral endoscopic myotomy for achalasia. Are results comparable to laparoscopic Heller myotomy?

OBJECTIVE: Per-oral endoscopic myotomy (POEM) has recently been introduced as a minimal invasive alternative to conventional treatment for achalasia. This study aimed to clarify the feasibility and the short-term clinical efficacy of POEM as compared to laparoscopic Heller myotomy (LHM). METHODS: Treatment outcomes were prospectively recorded and compared between the procedures in a nonrandomized fashion. Reduction rate (RR) in timed barium esophagogram (TBE) was calculated at 1, 2 and 5 min after barium ingestion as: RR = 1- postoperative barium height/preoperative barium height. Risk factors for treatment failure defined as the proportion of patients with RR <0.5 (1 min) and gastroesophageal reflux (GER) after POEM were analyzed. RESULTS: Forty-two consecutive patients who underwent POEM were compared to 41 patients who had a LHM during the immediate time period prior to the introduction of POEM. Ninety percent of the cases reported complete symptom relief after POEM. The percentage of esophageal emptying and RR in TBE improved dramatically by both procedures without significant difference. A longer operation time (odds ratio [OR] 32.80, 95%CI 2.99-359.82, p = 0.004) and younger age (OR 26.81, 95%CI 2.09-344.03, p = 0.012) were the independent predictors of treatment failure after POEM. GER was observed in seven patients where previous dilatation (OR 8.59, 95%CI 1.16-63.45, p = 0.035) and higher body mass index (OR 8.69, 95%CI 1.13-66.63, p = 0.037) were the independent predictors for symptomatic GER after POEM. CONCLUSION: POEM seems to be a safe and effective treatment option for achalasia in the short-term perspective; an effect well comparable to LHM.

[New method of treating achalasia is now being tested. Minimally Invasive POEM has produced promising results so far]. / Ny metod att behandla akalasi prövas nu - Minimalinvasiva POEM har gett lovande resultat hittills.

Achalasia of the cardia is a motor disorder of the esophagus and lower esophageal sphincter with dysphagia as the dominating symptom. The diagnosis is based on esophageal manometry and barium swallow. During work-up dysphagia of other origin should be excluded by endoscopy. Standard treatment of achalasia today is laparoscopic esophagogastromyotomy with partial fundoplication or pneumatic dilatation of the lower esophageal sphincter. POEM (PerOral Endoscopic Myotomy), a new minimally invasive technique, has recently been introduced in Sweden. So far, 45 patients have been treated. POEM is currently being compared with laparoscopic esophagogastromyotomy within a European randomized multicenter study.

Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial.

BACKGROUND: The optimal anti-reflux procedure after Heller cardiomyotomy for oesophageal achalasia remains unclear. The most commonly used procedure is the anterior partial fundoplication according to Dor, although during recent years the posterior counterpart (Toupet) has become popular. METHODS: Patients with newly diagnosed achalasia and referred for cardiomyotomy were randomised to receive either an anterior or partial posterior fundoplication following a classical cardiomyotomy. The effect of surgery was assessed during the first postoperative year by Eckardt scores, EORTC QLQ-OES18 scores and HRQL questionnaires. Timed barium oesophagogram (TBO) and ambulatory 24-h pH monitoring were performed to determine oesophageal emptying and the degree of reflux control, respectively. RESULTS: Forty-two patients were randomised into Dor (n = 20) and Toupet (n = 22) groups. Eckardt scores improved dramatically with both procedures, but the EORTC QLQ-OES18 (functional scales) scores revealed significantly better relative improvements in the Toupet group compared to the Dor repair (P = 0.044). Corresponding advantages in favour of Toupet were observed postoperatively in the percentage of oesophageal emptying at TBO (P = 0.011 in height and P = 0.018 in area), an effect not observed in the Dor group. There were no other significant differences recorded between the study groups concerning HRQL evaluations and objective assessment of gastro-oesophageal acid reflux. CONCLUSIONS: A partial posterior fundoplication after cardiomyotomy seems to achieve more improvement in oesophageal emptying and EORTC QLQ-OES18 functional scale scores than the anterior fundoplication. Otherwise no differences between the two anti-reflux repairs were noted. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01933373.

Comparison of wireless 48-h (Bravo) versus traditional ambulatory 24-h esophageal pH monitoring.

OBJECTIVE: To compare wireless with catheter-based esophageal pH recordings. MATERIAL AND METHODS: Forty-five patients with symptoms suggestive of gastroesophageal reflux disease and 47 healthy volunteers were investigated in a university-affiliated hospital; 48-h wireless esophageal pH recording was performed. During the first 24 h, simultaneous traditional pH recording by catheter was undertaken. Nine of the volunteers underwent repeated measurements with both techniques. Outcome measures were feasibility, agreement, concordance of diagnostic yield, reproducibility, and subjective symptoms. RESULTS: Subjective parameters were less affected when using the wireless technique alone (p<0.05). On using the wireless technique, esophageal acid exposure was underestimated approximately by half compared with traditional recording (p<0.05). Although pH data obtained with the two techniques were correlated (r(2)=0.66, p<0.001), the range between limits of agreement was wide (-3.7 to 10.0 percentage units of total time pH <4). Coefficients of variation for repeated measurements were 60.1+/-26.3% for catheter recordings, and 66.0+/-47.3 for wireless recordings on day 1 (NS). Concordance of diagnostic yield was 81.5% with all subjects included. CONCLUSIONS: Forty-eight-hour wireless Bravo pH monitoring is feasible but consistently underestimates esophageal acid exposure compared to the conventional technique. Although there is a significant correlation between the two techniques for pH recordings, the wide range in limits of agreement and the large coefficient of variation with both techniques suggest that the two methods are not immediately interchangeable for use in clinical practice.

Twelve months' follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study.

OBJECTIVE: The Bard EndoCinch plication technique has been reported to improve symptoms and reduce oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GORD). However, no placebo-controlled studies have been published as yet. The purpose of this study was to evaluate the effects of the EndoCinch plication technique in a randomized, placebo-controlled setting. MATERIAL AND METHODS: Forty-six otherwise healthy subjects with objectively verified GORD requiring regular use of proton-pump inhibitors (PPIs) were enrolled in the study. Patients were randomized to the EndoCinch plication technique or a sham procedure. Pre- and post-procedure assessments included gastro-oesophageal endoscopy, oesophageal manometry and 24-h pH recording, quality of life (QoL) assessment and use of PPIs. RESULTS: Reflux-specific symptoms and use of PPIs (total intake as well as number of patients not taking PPIs) improved in both groups at 6 weeks and at 3 and 12 months post-procedure (p<0.05) with an increased improvement in the treatment group at 3 months compared to controls (p<0.05 versus sham). There were no inter- or intra-group differences in endoscopic findings, oesophageal manometry or acid exposure before or at 3 or 12 months post-procedure. Gastro-oesophageal endoscopy showed that 71% and 67% of sutures remained at 3 and 12 months, respectively. CONCLUSIONS: Although some short-term effects were achieved, it was found that there were no differences between the treatment and control groups after 12 months and the lack of reduction of oesophageal acid exposure suggests that, in its present form, the EndoCinch plication technique is not to be recommended for use in clinical practice. It is suggested that the lack of long-term effects is primarily due to detachment of the sutures.