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Guidelines for Surgical Treatment of Gastro esophageal Reflux Disease (GERD) IntroductionIn the field of surgery, present era, GERD has long been noted as a public health concern of immense importance. Heartburn affects nearly two thirds of US adults at different ages in their lives, and touches for 41/2 to 5 million physician office visits every year. DefinitionAccording to the Montreal consensus GERD was defined as “a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications.” Symptoms were considered “troublesome” if they adversely affected an individual’s well being. DiagnosisPrior to surgery, objective documentation of gastro esophageal reflux is compulsory.Flexible esophagoscopy is an important option. Endoscopic procedure for visualization of any “mucosal break”, can be understood as an area of slough or erythema distinctly bifarcated from adjacent normal‑appearing mucosa, is considered fundamental proof of GERD in the appropriate clinical setting. This mucosal break is the least endoscopic lesion that is a reliable indicator of reflux esophagitis. Medical Versus Surgical TreatmentSeven randomized controlled trials with follow-up of these studies ranging from 1 to 10.6 years have compared surgical therapy with medical therapy, For the treatment of GERD till date. These studies strongly support surgery as an effective alternative to medical therapy(level I) both for patients with good symptom control on medical therapy and for those who achieve only partial symptomatic relief from PPIs (level I). Surgical Technique, Learning Curves, and their Influence on OutcomeThis approach has been criticized in the literature as the lack of standardization makes outcome comparisons difficult because the choice of technique for antireflux surgery has traditionally been based on anatomic considerations and the surgeon’s preference and expertise,. Recently, a randomized trial designed to compare medical and surgical therapy managed to standardize the Nissen fundoplication technique across several institutions and surgeons. Based on a consensus of 40 experienced foregut surgeons, the following standardized approach to Nissen fundoplication was followed: a) opening of the phrenoesophageal ligament in a left to right fashion, b) preservation of the hepatic branch of the anterior vagus nerve, c) dissection of both crura, d) transhiatal mobilization to allow approximately 3 cm of intraabdominal esophagus, e) short gastric vessel division to ensure a tension-free wrap, f) crural closure posteriorly with nonabsorbable sutures, g) creation of a 1.5 to 2-cm wrap with the most distal suture incorporating the anterior muscular wall of the esophagus, and h) bougie placement at the time of wrap construction. This standardization led to excellent postoperative outcomes comparable with medical treatment and included a 2% conversion rate, 3% postoperative complication rate, and a median postoperative length of stay of 2 days (level I). Partial Versus Total FundoplicationThe differences between partial and total fundoplications and one randomized controlled trial between two partial fundoplications (level I) have been done by undertaking eleven randomized controlled trials and two metaanalyses investigated. Laparoscopic Versus Open Treatment of GERDTill today 12 randomized controlled trials and two metaanalyses have compared the results of open with laparoscopic fundoplication. All but one of these trials compared open with laparoscopic Nissen fundoplication with some technical variations. Anterior versus Nissen fundoplicationFour randomized controlled trials reporting on 457 patients with a follow-up ranging from 6 months to 11 years have been published(level I) that compare the laparoscopic anterior fundoplication with the laparoscopic Nissen fundoplication. Two studies included a 180 degree anterior fundoplication and the other two a 90 degree one. Based on the findings of these trials, the anterior fundoplication was associated with significantly less postoperative dysphagia according to at least one of the evaluated dysphagia parameters compared with the Nissen fundoplication even during long term follow-up (up to 11 years) (level I). On the other hand, the anterior fundoplication was found to be less effective for reflux control (based on patient symptoms and objective tests) as more patients required reoperations for reflux control (level I). Patient satisfaction ratings were similar between the groups in all studies up to 11 years after surgery (level I). Whether there are differences between a 90- and a 180 degree fundoplication is unclear, as no comparative studies exist; however, Engstrom et al have suggested that the 90 degree is inadequate (level I). Anterior versus Toupet fundoplicationOne randomized controlled trial has compared two partial fundoplications, 120 degree anterior and 180 to 200 degree posterior (level I). This study followed 95 patients for 5 years (93% follow-up) and found that posterior fundoplication was superior to the anterior by achieving better reflux control without increased incidence of postoperative dysphagia. In addition, this study demonstrated statistically significantly higher PPI intake, more esophageal acid exposure, higher reoperation rates, and lower patient satisfaction after anterior fundoplication during long-term follow-up and concluded that an anterior repair cannot be recommended for GERD due to insufficient reflux control (level I). Toupet versus Nissen fundoplicationThe majority of published studies have demonstrated lower dysphagia rates after Toupet fundoplication and no difference in heartburn control between the two procedures at follow up (level I).Nine randomized controlled trials (including both open and laparoscopic techniques) with follow-up of 1 to 5 years have compared the Toupet fundoplication with the Nissen.(level I). In addition, no differences have been demonstrated for any of the other outcome parameters. The Nissen fundoplication length did not influence reflux control, but a trend for a higher dysphagia rate was noted with the 3-cm wrap compared with the 1.5 cm wrap at the 12 month follow up of this study. (level I). Interestingly, a very recent study that compared variable lengths of fundoplication (1.5 cm vs 3 cm) for both procedures demonstrated that the 3-cm Toupet achieved superior reflux control over the 1.5 cm Toupet without differences in postoperative dysphagia. Longer follow-up data are needed to confirm the long-term comparative effectiveness between the Toupet and Nissen fundoplications as the current level I evidence does not go beyond 5 years. This is especially important because retrospective studies suggest inferior long-term reflux control after Toupet (level III). Technical Factors That May Influence OutcomesThe following technical issues and patient factors may influence the outcome of fundoplication and are discussed separately: Short gastric vessel divisionFive randomized controlled trials have evaluated the impact of short gastric vessel division on outcomes following laparoscopic antireflux surgery. Evidence from these high quality studies suggests no difference in physiologic, symptomatic, and quality of life outcomes up to 11 years after surgery (level I). Furthermore, division of short gastric vessels at the time of fundoplication has been found to increase operating time (level I-II), increase flatus production and epigastric bloating, and decrease the ability to vent air from the stomach (level I). However, it must be mentioned that a previous review based on the data from all but the most recent randomized controlled trial gave a low grade recommendation due to the inconsistency of results and expert opinion in North America advocates for routine division. Robotic surgery and its useThe use of robotic surgery has been reported to be safe and feasible with similar outcomes during up to 1 year follow-up compared with laparoscopic antireflux surgery (level I-II). Most of the five available randomized controlled trials have reported a significant increase in operating times and cost when the robot is used(level I). Unfortunately, there are no clinical data comparing ergonomics and surgeon workload between these two approaches; however, level I data from simulator studies have shown less surgeon workload with the use of the robot . Crural closureThere have been no randomized controlled trials comparing closure with no closure of the crura. Individual reports stress the benefits of posterior crural repair for satisfactory outcomes, but others report no difference in outcomes. Several authors have reported selective crural closure based on the size of the hiatal opening, but no clinical comparisons exist. One study recommended division of the short gastric vessels, posterior closure of the crura, and fixation of the wrap to the crus demonstrating significantly decreased incidence of wrap slippage and need for secondary intervention when following this approach (level III). One randomized controlled trial compared the efficacy of anterior with posterior crural repair and reported no difference in the anterior or posterior closure groups in terms of postoperative dysphagia, heartburn, and overall satisfaction at 6 month follow-up. To achieve a similar dysphagia rate, however, more patients in the posterior closure group had to undergo a second surgical procedure (level I). The morbidly obese patient and Antireflux surgeryThere is a clear association between GERD and morbid obesity with the disease being more prevalent as the body mass index (BMI) increases. The long-term effectiveness of fundoplication in obese individuals (BMI >30) has been questioned due to higher failure rates (level II-III) compared with normal weight patients. Nevertheless, others have reported equivalent outcomes in obese and normal weight individuals (level II-III). The laparoscopic Roux-en-Y gastric bypass (LRYGB) is the most effective and advantageous treatment option for GERD in the morbidly obese patient, since it treats GERD effectively and provides the additional benefit of weight loss and improvement in comorbidities and is therefore the procedure of choice by many experts (level II-III). Laparoscopic Roux-en-Y gastric bypass has also been reported to be a feasible and efficacious treatment in morbidly obese patients who have previously undergone laparoscopic antireflux surgery, although it is technically demanding and has a higher morbidity (level III). While adjustable gastric banding may also improve GERD symptoms, conflicting reports exist, and it is therefore not the procedure of choice for this indication . Esophageal dilators and its useLevel I evidence suggests that the use of an esophageal dilator decreases the long-term incidence of dysphagia. The only available randomized controlled trial reported a significant decrease in the postoperative dysphasia rate at 11 months follow-up in patients who had a 56 French bougie placed at the time of surgery versus patients who did not have a bougie placed, and there was no difference in perioperative morbidity and mortality (level I). There was, however, a 1.2% incidence of esophageal injury due to placement of the bougie (level I). Success and its Indicator/PredictorsPreoperative patient compliance with antireflux medicationsOne study examined the predictive value of self-reported preoperative compliance with medical treatment. Patients compliant with their preoperative medical treatment of GERD with PPI showed a statistically significant larger improvement in the postoperative gastrointestinal quality of life index than patients who were non-compliant preoperatively. In addition, non-compliant patients had higher rates of post-fundoplication dysphagia at 1 year follow-up. AgeNo significant affect of age has been found to the outcomes of antireflux surgery. Besides a tendency for longer postoperative hospitalization, patients > 65 years of age can expect an excellent outcome after surgery in at least 90% of cases, similar to younger patients. Psychological disease and interventionWhile major depression has not been shown to influence objective physiologic outcomes of fundoplication, it appears to impact postoperative quality of life. In particular, quality of life scores have been shown to improve postoperatively in depressed patients but to a lesser extent than in healthy subjects. In addition, severe postoperative dysphagia and severe bloating were found to be statistically significantly more common in patients with major depression compared with healthy controls (level II). One study concluded that a 270 degree partial fundoplication had better outcomes in patients with major depression compared with a 360 degree fundoplication due to a lower incidence of postoperative dysphagia and gas bloat syndrome (level II). Postoperative “diaphragmatic stressors”Sudden increases in intra-abdominal pressure in the early postoperative period are thought to predispose a patient to anatomical failure of fundoplication. One study has suggested that early postoperative gagging, belching, and vomiting (especially when associated with gagging) are predisposing factors for anatomical failure and the need for revision (level III). In addition, hiatal hernias >3 cm at original operation have been reported to be predictors for anatomic failure (level II). Esophageal functionA normal LES pressure on manometry has not been shown to be associated with increased rates of postoperative dysphagia (level II). Patients with nonspecific spastic esophageal motor disorders (such as nutcracker esophagus, hypertensive LES syndrome) have been reported to be at increased risk for postoperative heartburn, regurgitation, and dysphagia after a 360 degree wrap (level II). Atypical symptomsPatients with atypical symptoms of GERD, such as chest pain, asthma, chronic cough, hoarseness, otitis media, atypical loss of dental enamel, idiopathic pulmonary fibrosis, recurrent pneumonia, and chronic bronchitis are known to respond less well to fundoplication compared with patients with typical symptoms (heartburn and regurgitation) (level II). For this reason, several investigators have sought ways to preoperatively predict the success of fundoplication performed for atypical symptoms. Of the factors examined, the best predictors have been found to be good symptom correlation with reflux episodes during combined esophageal multichannel intraluminal impedance and pH monitoring (level II), and a positive Bernstein esophageal acid infusion test (level II).
Patterns of refluxPatients with upright reflux are thought to have more maladaptive behaviors associated with their reflux, including aerophagia, regurgitation, and dyspepsia compared with patients who experience typical reflux when supine. Nevertheless, with the exception of one study that suggested that patients with upright reflux have an increased rate of gas bloat syndrome postoperatively, the preponderance of evidence suggests that laparoscopic Nissen fundoplication is equally effective regardless of the pattern of reflux (level II). Response to preoperative PPISymptomatic response to preoperative PPI treatment has been shown to be an excellent predictor of symptomatic response to fundoplication. One non-response to PPI is not considered a contraindication to antireflux surgery as studies have demonstrated very good success rates in these patients (level II). However, study found that patients with no response to preoperative PPI administration had lower satisfaction rates after fundoplication compared with patients who had at least a partial response (level II). Preoperative gastric emptyingIt has been suggested that delayed gastric emptying may affect postoperative gastric distension and overall surgical outcomes. However, one large prospective non-randomized trial showed no relationship between gastric emptying and outcome following fundoplication (level II). OutcomesMultiple studies have evaluated the short- and long-term outcomes of laparoscopic antireflux surgery with follow-up ranging up to 11 years .Laparoscopic antireflux surgery has proven to be a safe, effective, and durable treatment option for GERD (level I-III). Response of atypical reflux symptoms to antireflux surgeryAtypical symptom improvement has been reported in 67% to 92% of patients after antireflux surgery (level II-III). Specifically, cough has been shown to significantly improve following laparoscopic antireflux surgery (level II-III) with cure rates of 53% (level II), short-term improvement rates from 69% to100% (level II), and long-term improvement rates of 71% (level II). Hoarseness (level II-III), sore throat (level II-III), and bronchitis (level III) have also been reported significantly improved following surgery. Improvement has also been reported for pulmonary symptoms (level II-III), aspiration (level III), and wheezing (level II-III) symptoms. While some reports have shown improvement in asthma (level II-III) and laryngitis (level III) following antireflux surgery, others have reported no benefit (level II-III). Response of typical GERD symptoms to antireflux surgeryTypical symptoms of gastrointestinal reflux disease improve in the majority of patients after surgery during short- (level I-III) and long-term follow-up (>5 years) (level I-III). Nevertheless, symptom control may be waning over time as studies with shorter follow-up periods (3 years) report, in general, better symptom resolution (90%) than studies with longer term follow-up (67% of patients at 7-year follow-up (level I). Improvements have also been demonstrated for patients with Barrett’s esophagus, elderly patients, and patients with and without preoperative esophagitis. Objective outcomesFunctional improvement, including a significant increase in LES pressure (level I-III) and a significant decrease in acid exposure (level I-III) compared with preoperative values are documented in both short- and long-term studies, with pH studies returning to normal in approximately 88% to 94% of patients (level II). Postoperative complicationsComplication rates following antireflux surgery vary related to experience, technique, and degree and intensity of follow-up. Conversion rates to open surgery for laparoscopic antireflux surgery range from 0 to 24% (level I-III); however, most series from high-volume centers report conversion rates <2.4% (level I). Quality of life and satisfaction with surgerySatisfaction rates for surgery range from 62% to 97% (level II-III) with long-term satisfaction rates (follow-up >5 years) ranging from 80% to 96% (level II-III). Additionally, 81% to 95% of patients, in both short- and long-term follow-up, stated that they would undergo surgery again (level II-III). Quality of life significantly improved after laparoscopic antireflux surgery in both early and long-term studies as documented from a variety of quality of life surveys including generic and disease-specific quality of life surveys (level II-III). Postoperative use of acid reducing medicationsThe resumption of acid reducing medications in patients after antireflux surgery has been reported to range widely (0 to 62%) at both short- and long-term follow-up (level I-III). Long-term medication use has been reported to range from 5.8% to 62% (level I-III) with most studies reporting rates <20% (level II-III). One randomized controlled trial, however, reported a 62% incidence of antacid medication resumption after antireflux surgery, which constitutes a very high rate compared with the rest of the literature. Barrett's Esophagus and Antireflux SurgeryDefinition and demographicBarrett’s esophagus is defined as a metaplastic change in which the squamous epithelium of the esophagus is replaced by a columnar epithelium containing goblet cells (intestinal metaplasia or IM). This metaplastic process is believed to be initiated by inflammation and injury induced by chronically refluxed acid and bile. Barrett’s esophagus is present in 1.65% of the general population, 8.6% of symptomatic GERD patients presenting to a tertiary care center, and 10.8% of patients undergoing antireflux surgery. Barrett’s esophagus (neoplasia not present) is associated with a significantly increased risk for developing esophageal adenocarcinoma (approximately 100 fold) over that of the general population. As intraepithelial neoplasia develops, the annual per patient risk for cancer increases further. Histological assessment of Barrett’sThe histological features of biopsy specimens from a Barrett’s esophagus are graded according to the presence or absence of neoplasia; 1) no neoplasia (also known as non-neoplastic IM), 2) indefinite for neoplasia (IND), 3) low-grade intraepithelial neoplasia (LGIN), 4) high-grade intraepithelial neoplasia (HGIN), and intramucosal carcinoma (IMC). Standard, endoscopically-acquired biopsy specimens may not penetrate deeply enough into the esophageal wall to rule out involvement of the submucosa by cancer, therefore EMR or EUS may be indicated in cases suspicious for advanced neoplasia (level II). A finding of neoplasia prompts review by more than one expert pathologist to confirm the diagnosis and grade, given the interobserver variability reported for Barrett’s neoplasia (level I). Preoperative endoscopyUpper endoscopy should be performed as part of the preoperative work-up for antireflux surgery, as erosive esophagitis and Barrett’s esophagus are independent objective diagnostic criteria for GERD. A diagnosis of Barrett’s esophagus, depending on histological grade, may alter patient eligibility for and timing of antireflux surgery. When a columnar-lined esophagus is detected for the first time at preoperative endoscopy, four-quadrant biopsies are obtained from every 1-2 cm of the affected portion of the esophagus to confirm Barrett’s and determine its histological grade. Endoscopic mucosal resection (EMR) may be used to remove eligible areas of nodularity or ulceration to rule out advanced neoplasia warranting immediate intervention (level II). If a patient has been diagnosed with Barrett’s before preoperative endoscopy, expert review of the prior pathology or repeat biopsy may be considered to confirm the histological grade before antireflux surgery (level III). Impact of histology findings on antireflux surgery candidacy and timing of surgeryA finding of HGIN or adenocarcinoma on preoperative biopsy requires immediate attention and may delay (in the case of HGIN and IMC) or exclude (in the case of adenocarcinoma with submucosal invasion or deeper) antireflux surgery. Additional work-up for HGIN or adenocarcinoma may include chest CT, EUS and/or staging EMR (if visible lesion exists that is amenable to resection) (level II). Antireflux surgery for Barrett’s esophagusThe goals of treatment for patients with Barrett’s esophagus are similar to those of patients with gastroesophageal reflux disease patients and include relief of symptoms and cessation of ongoing epithelial damage related to reflux. Surveillance of Barrett’s esophagus after antireflux surgeryMedical professional society guidelines recommend surveillance endoscopy with four-quadrant biopsies to detect neoplastic progression every 3 years for non-neoplastic IM, every 6-12 months for LGIN, and every 3 months for HGIN. In patients who have had successful complete eradication of Barrett’s esophagus, surveillance should continue according to their baseline Barrett’s histology grade until further evidence is available. Antireflux surgery does not change these recommended surveillance guidelines. Further, there is no evidence indicating that surveillance is more difficult or less effective after antireflux surgery. |
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