Patient response to marketing minimally invasive surgery for heartburn

Background: Over 40% of Americans suffer from ``heartburn' at least once a month. This and other manifestations of gastroesophageal reflux (GERD) are often treated with neglect by both patients and their primary care physicians. Diagnostic evaluation is all too often sought only in late stages of the disease. We studied the response to a media campaign promoting minimally invasive surgery as a cure for longstanding heartburn. Methods: The information was publicized on 14 TV and six radio stations over 4 weeks. Patients were referred to an 800-number and data on the following topics were obtained using a standardized questionnaire: demographics, reflux symptoms, previous specialist referral, diagnostic evaluation and treatment, insurance information, and reasons for and expectations in calling. All questionnaires were screened for likelihood of GERD (high, medium, low). A return call was placed to triage patients (surgical or medical appointment, information only, no contact). Results: We received calls from 1,389 potential patients. Based on symptoms, medical therapy, and previous evaluation, 891 (64%) were judged to likely have GERD and assigned high-priority status. Of the patients providing insurance information, 32% were enrolled in an HMO; 29% commercial; 16% Medicare; 14% employer based; and 9% had no insurance. Six hundred ninety-eight high-priority patients were contacted. Of these, 402 (58%) wanted information only; 228 (33%) desired surgical and 68 (%) medical appointments. Two hundred fifteen patients (16% of callers) were seen by a surgical or medical consultant. One hundred thirty-five underwent diagnostic studies, of which 77 (57%) had pathologic esophageal acid exposure. Eighty-three patients have undergone surgery to date—60 laparoscopic and 14 open antireflux procedures; nine had other surgical procedures. Conclusions: Surprisingly, 64% of patients responding to a marketing campaign for heartburn have typical symptoms of GERD, have consulted one or more physicians and/or received medical treatment. More than half the patients tested (77/135) were found to have a positive 24-h pH study, and 78% (60/77) of these elected antireflux surgery to control their reflux symptoms. Received: 3 April 1997/Accepted: 10 June 1997     

Symptomatic and Clinical Improvement in Morbidly Obese Patients with Gastroesophageal Reflux Disease Following Roux-en-Y Gastric Bypass

Background: Patients who suffer with gastroesophageal reflux Disease (GERD) endure a worsening of symptoms as their weight increases. When medical treatment of this condition in the morbidly obese patients fails, surgical intervention may be indicated. Choosing a procedure which not only helps achieve weight control but which also relieves symptoms and complications of GERD is the goal. We present a review of patients who have undergone Roux-en-Y Gastric Bypass (RYGBP) and related procedures for this disease. Methods: One hundred eighty-eight patients undergoing surgery for morbid obesity and for GERD in 1992-1996 were contacted by mail or phone. All of these patients had undergone preoperative esophagogastroduodenoscopy to grade the severity of their disease. Their preoperative symptoms were compared to those experienced postoperatively. Results: One hundred thirty patients underwent a RYGBP with modified Hill fundopexy, 22 patients underwent a distal gastrectomy with modified Hill fundopexy, 8 patients underwent distal gastrectomy alone and 28 patients underwent RYGBP alone. There have been no deaths. There were nine surgical complications, eight early and one at 2.5 years postoperation. Follow-up is 4-48 months. The average BMI dropped from 43 to 30.2 kg/m². Whereas all patients were on some form of medical therapy before surgery, only 14 reported the need for medication postoperatively. Conclusions: Surgical intervention for weight control and treatment of GERD has been highly successful in our experience both with respect to weight control and to the reduction of reflux symptoms. Depending upon endoscopic and operative findings a RYGBP with or without an antireflux procedure can provide dramatic improvement. Gastrectomy with antireflux modifications is appropriate in selected cases.     

Pharyngeal pH measurements in patients with respiratory symptoms before and during proton pump inhibitor therapy.

BACKGROUND: Pharyngeal pH monitoring is a diagnostic tool used to identify Gastroesophageal reflux disease (GERD) as an etiology of respiratory symptoms. We performed pharyngeal pH monitoring on 14 patients with respiratory symptoms thought to be induced by GERD. METHODS: Symptoms and pH monitoring (esophageal and pharyngeal) were assessed prior to and 3 months after the initiation of double-dose proton pump inhibitor therapy. RESULTS: Symptoms included cough, hoarseness, and throat clearing. Ten patients had at least one episode of pharyngeal reflux (PR+) and 4 patients had no pharyngeal reflux (PR-). Pharyngeal reflux episodes in PR+ patients decreased from 3.5 to 0.9 (P <0.05) per day with 8 of 10 (80%) patients having elimination or reduction of such episodes. Eight of 9 PR+ patients (89%) with suppressed pharyngeal reflux on medical therapy had resolution of respiratory symptoms. Three of 4 PR- patients (75%) had persistent symptoms on medical therapy. CONCLUSIONS: Proton pump inhibitor therapy improves clinical symptoms and decreases pharyngeal reflux episodes in patients with respiratory symptoms related to GERD. Direct measurement of pharyngeal pH is helpful in the identification of patients likely to respond to antireflux therapy.     

Selection criteria among gastroenterologists and surgeons for laparoscopic antireflux surgery

Background: Symptomatic gastroesophageal reflux disease (GERD) affects a substantial proportion of the American population. The diagnosis and treatment of GERD has advanced tremendously over the past 30 years. However, there remains a lack of understanding about the differences and advantages that laparoscopic antireflux surgery offers and a lack of agreement on the ideal surgical candidate. The purpose of this study was to determine whether a significant difference exists in the practice habits and selection criteria for surgery between gastroenterologists and laparoscopic surgeons. Methods: Surveys were sent to 1,000 randomly selected members of the American Gastroenterological Association (AGA) and to 1,000 randomly selected members of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES). As a result, 20% of the AGA surveys and 33% of the SAGES surveys were completed and returned. Results: The AGA group considered patients whose symptoms are not well controlled, those who have complications of disease, and those who require significant lifestyle changes to control their symptoms as the best candidates for surgical evaluation. As a group, gastroenterologists remain somewhat hesitant to refer patients for laparoscopic antireflux surgery. Surgeons considered patients whose symptoms have been well controlled with medical therapy, those who have complications of disease, and those who require significant lifestyle changes to control their symptoms as ideal candidates for fundoplication. Conclusion: A consensus should be reached between surgeons and gastroenterologists in establishing criteria for surgical intervention to manage GERD.     

Minimally invasive approaches to antireflux surgery

Gastroesophageal reflux disease is one of the most common disorders affecting western civilization. Historically, surgical antireflux therapy was reserved for patients who had failed medical therapy, typically in the presence of refractory ulcers or difficult-to-manage strictures. More recently, with improvements in acid control, these acid-pepsin-related complications of reflux have been replaced by the malignant complications of reflux disease, with emphasis now on total control of reflux. Recent developments in surgical technique and the demonstrated effectiveness of a variety of minimally invasive treatment options have changed our approach to these patients. This article summarizes the recommended diagnostic evaluation of patients with reflux symptoms and the current indications for antireflux surgery. The techniques of commonly performed minimally invasive antireflux procedures are described along with a review of the results to be expected. Future prospects for improving the management of reflux are discussed; these include recently described nonsurgical methods for restoring competency to the lower esophageal sphincter.     

Partial versus complete fundoplication: is there a correct answer?

Gastroesophageal reflux disease is a common disorder, and patients diagnosed with GERD face a lifelong treatment requirement. A surgical antireflux procedure may be offered as an alternative to lifelong treatment with proton-pump inhibitors. Many investigations have been performed to help discover the best surgical alternative to medical management. An ideal antireflux procedure should be safe, effective, durable, and result in minimal complications.Total fundoplication in the form of Nissen fundoplication is the most widely used antireflux operation worldwide. Although its efficacy is well documented, the clinical success rate in terms of reflux control is occasionally compromised by troublesome mechanical side effects. Because of these unsatisfactory symptoms and continued hindered quality of life, the Nissen fundoplication has undergone many modifications. The current standard appears to be the 2 cm floppy Nissen; however, the alternative approach has been the use of a partial fundoplication, most frequently the Toupet procedure. Both the Nissen and Toupet fundoplications have proven to provide relief in the majority of patients, but each has its own drawback. Patients undergoing Nissen fundoplication have a higher incidence of dysphagia early after operation, although this appears to resolve in most. The Toupet, on the other hand, may not be as durable, and may lead to the early re-emergence of symptoms.The problem of post-Nissen dysphagia led many surgeons to believe that the Nissen night be contraindicated in patients who have dysmotility,because it would cause even greater dysphagia; however, recent articles have not demonstrated this to be the case. It seems that the floppy Nissen performed over a large bougie (56-60 Fr) with division of short gastrics and crural closure is an acceptable operation for reflux in both those who have normal motility and those who have mild to moderate dysmotility. Thus, for most patients who have GERD and normal motility, either procedure appears effective in the majority of patients; however, those patients who have severe dysmotilty disorders and who require an antireflux procedure(ie, scleroderma, postmyotomy achalasia) are likely best served with a partial fundoplication.     

Clinical outcome of Laparoscopic antireflux surgery for patients with irritable bowel syndrome

Background The prevalence of irritable bowel syndrome (IBS) is higher among subjects with gastroesophageal reflux disease (GERD). This study aimed to assess the effect of IBS on the postoperative outcome of antireflux surgery.Methods For this study, 102 patients who underwent laparoscopic fundoplication were screened preoperatively for IBS with the Rome II criteria. There were 32 patients in the IBS group and 70 patients in the non-IBS group. Most of the patients (97%) (31 of 32 IBS and 68 of 70 non-IBS patients) had both pre- and postoperative IBS evaluation. A visual analog GERD-specific scoring scale was used to evaluate GERD symptoms prospectively.Results In both groups, GERD symptom scores were statistically improved postoperatively. Of the 31 IBS patients 25 (80.6%) showed a reduction in their symptoms below the Rome II criteria for IBS diagnosis postoperatively.Conclusion Irritable bowel syndrome does not have a negative effect on the outcome of laparoscopic antireflux surgery. Surgical correction of GERD may improve the severity of irritable bowel symptoms.     

Extraesophageal manifestations of reflux disease: myths and reality.

Because of the anatomic proximity of the esophagus and the upper respiratory tract, it is not surprising that, in some patients with GERD, symptoms attributable to the respiratory and upper aerodigestive tract may occur. The prevalence of respiratory or other extraesophageal manifestations of GERD remains unknown, however, primarily because in any given patient it is often difficult to determine whether GERD is causing the extraesophageal condition or whether the two conditions are coexisting independently. Acid can reflux into the hypopharynx or trachea in some patients with GERD, thereby causing a variety of respiratory tract symptoms. Additionally, vagovagal reflexes triggered by acid that comes in contact with the esophageal or tracheal mucosa may contribute to the pathogenesis of GERD-related respiratory symptoms, particularly wheezing and coughing. The clinician should be particularly suspicious of underlying GERD in patients with unexplained dental caries, posterior laryngitis, chronic unexplained cough, and intrinsic asthma that does not respond to (or worsens with) bronchodilator therapy. Intensive medical antireflux therapy should be instituted in patients with a suspected extraesophageal manifestation of GERD. Failure to respond to this should not lead automatically to antireflux surgery; the clinician should use 24-hour pH monitoring to document the relationship between GERD and extraesophageal complications and to demonstrate that intensive medical therapy has indeed failed to eliminate acid reflux.     

Effectiveness of laparoscopic fundoplication for gastro-oesophageal reflux

BACKGROUND: Gastro-oesophageal reflux (GERD) is a common condition. Many patients respond to conservative therapy. Severe symptomatic cases and those who fail medical treatment are referred to surgery. The long-term results of open fundoplication surgery have been good with a more than 90% response after 10 years of follow-up. The introduction of laparoscopic fundoplication achieved the same results with shorter hospital stay, a better cosmetic result and less cost to the health care providers. PATIENTS AND METHODS: 74 patients who failed medical treatment for GERD were treated by laparoscopic fundoplication. The Toupet procedure was performed in 66 of these patients, the others patients had a Nissen-type fundoplication. The patients were followed up for a mean period (+/- SD) of 14.8 +/- 8.8 months (range 3-33 months). RESULTS: Most of the patients were males (n = 65). The mean age (+/- SD) of all the patients was 36.1 +/- 9.5 years (range 17-60 years). The majority (93.8%) reported disappearance of symptoms and are not using any antireflux medications. Five patients (6.7%) are considered failures of the procedures. Of these, three patients developed recurrence of reflux symptoms during the follow-up period. The other two patients developed complications, i.e. gas bloat, persistent vomiting and dysphagia which warranted taking down the wraps laparoscopically. Two patients developed a small incisional hernia at the site of the 10 mm port. The mean of hospital stay (+/- SD) was 3.1 +/- 1.3 days (range 1-7 days). CONCLUSION: Laparoscopic fundoplication is safe and effectively relieves reflux symptoms in patients who fail medical treatment.     

Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia

BackgroundGastroesophageal reflux disease (GERD) with or without hiatal hernia (HH) is now recognized as an obesity-related co-morbidity. Roux-en-Y gastric bypass has been proved to be the most effective bariatric procedure for the treatment of morbidly obese patients with GERD and/or HH. In contrast, the indication for laparoscopic sleeve gastrectomy (SG) in these patients is still debated. Our objective was to report our experience with 97 patients who underwent SG and HH repair (HHR). The setting was a university hospital in Italy.MethodsFrom July 2009 to December 2011, 378 patients underwent a preoperative workup for SG. In 97 patients, SG was performed with HHR. The clinical outcome was evaluated considering GERD symptom resolution or improvement, interruption of antireflux medications, and radiographic evidence of HH recurrence.ResultsBefore surgery, symptomatic GERD was present in 60 patients (15.8%), and HH was diagnosed in 42 patients (11.1%). In 55 patients (14.5%), HH was diagnosed intraoperatively. The mean follow-up was 18 months. GERD remission occurred in 44 patients (73.3%). In the remaining 16 patients, antireflux medications were diminished, with complete control of symptoms in 5 patients. No HH recurrences developed. “De novo” GERD symptoms developed in 22.9% of the patients undergoing SG alone compared with 0% of patients undergoing SG plus HHR.ConclusionSG with HHR is feasible and safe, providing good management of GERD in obese patients with reflux symptoms. Small hiatal defects could be underdiagnosed at preoperative endoscopy and/or upper gastrointestinal contrast study. Thus, a careful examination of the crura is always recommended intraoperatively.     

Symptomatic outcomes of laparoscopic antireflux surgery in patients eligible for endoluminal therapies

Background: This study compared clinical outcomes after laparoscopic antireflux surgery (LARS) in patients with gastroesophageal reflux disease (GERD) who would be eligible for endoluminal therapies (ET) with those in patients who would be excluded from ET. Methods: From 1995 to the present, 459 patients who underwent LARS were analyzed prospectively. Of these, 117 patients (25%) without preoperative dysphagia, stricture, esophagitis worse than grade 2 or hiatal hernia larger than 2 cm were considered potential candidates for ET (group 1). By these criteria, 342 patients (75%) were not eligible for ET (group 2). Medication use and GERD symptoms were evaluated and compared between the two groups. Results: Perioperative outcomes including duration of operation, morbidity, length of hospital stay and return to work were similar in the two groups. Although LARS significantly reduced medication use and GERD symptoms in both groups during a mean follow-up period longer than 2 years, there were no outcome differences between groups 1 and 2. The reported improvement in esophageal symptoms and overall satisfaction was 90% or more in both groups. Conclusions: The findings show that LARS is an effective treatment option in patients with GERD whether they are candidates for ET or not. In patients with uncomplicated GERD who currently meet inclusion criteria for ET, LARS provides excellent symptom relief and marked reduction in medication use during a mean follow-up period longer than 2 years.     

Laparoscopic antireflux surgery: how I do it?

Gastroesophageal reflux disease (GERD) affects an estimated 20% of the population in the US, and its prevalence is increasing worldwide. Lifestyle modifications and proton pump inhibitors (PPI) are effective in the majority of patients. However, some patients will become candidates for surgical intervention, because they have partial control of symptoms, do not want to be on long-term medical treatment, or suffer complications related to PPI. In these patients, a properly executed laparoscopic antireflux surgery controls esophageal and extra-esophageal symptoms and avoids life-long medical therapy. Important technical elements should be taken into account during the operation to avoid troublesome side effects and obtain optimal postoperative outcomes.     

Current medical management of gastroesophageal reflux disease

Gastroesophageal reflux symptoms are common. Not everyone who has heartburn has reflux, as some people have functional heartburn in addition to many other symptoms. Alternatively, not everybody who has reflux has heartburn, and many symptoms are identified in which reflux may be playing a role. In most cases, the initial management strategy is empiric medical therapy. Often, this brings symptom relief, but when it does not, alternative diagnoses need to be considered. High-dose treatment trials and ambulatory pH monitoring have become more important than endoscopy in the diagnosis of reflux. Patients who have reflux typically require a chronic disease approach. This can be with medical therapy, surgery, or endoscopic approaches. GERD is associated with decreased quality of life; however, given the many helpful treatment options, no one should suffer from the symptoms of GERD.     

Esophageal motility in the assessment of esophageal function

Esophageal manometry assesses lower esophageal sphincter (LES) pressure and its relaxation. In addition, it detects the ability of the esophageal body to initiate a peristaltic contraction and the contraction's amplitude in response to a water bolus. The study is indicated in patients with symptoms suggestive of an esophageal motor disorder and to assist in the diagnosis of some miscellaneous disorders. The most common disorders diagnosed by esophageal manometry are the primary motility disorders, such as achalasia. Manometry is indicated in the subset of patients with gastroesophageal reflux disease (GERD) who are being considered for antireflux surgery or have symptoms after antireflux surgery.     

Endoscopic antireflux therapy: the Stretta procedure

The Stretta procedure is safe and effective for the treatment of GERD. There are well-documented clinical trial data supporting its use, including a randomized sham-controlled study, single- and multi-center prospective trials, and community practice reports. The complication rate is within the acceptable range for therapeutic endoscopic procedures and less than the published complication rate for laparoscopic fundoplication. The durability of effect also is established beyond 2 years in several studies. Stretta should be added to the GERD management algorithm specifically for patients considering an antireflux surgical procedure but who are not accepting of the risks of surgery and anesthesia. These patients typically present with incomplete GERD control, despite optimal antisecretory drug therapy, or intolerance to medical therapy. Stretta should be considered only for patients who fit the anatomic inclusion criteria, whereas antireflux surgery should be reserved for those who do not. The decision to undergo antireflux surgery or Stretta must be based on the relative risks and benefits of each procedure. Although antireflux surgery provides better control of esophageal acid exposure than Stretta, the outcomes for GERD symptoms, quality of life, and reduction in PPI use are comparable. Stretta has a low risk of acute adverse events, has no reported cases of long-term dysphagia, and obviates general anesthesia and hospitalization, whereas antireflux surgery has a reported adverse event rate of approximately 2%, a considerable incidence of dysphagia, and requires general anesthesia and 1 to 2 days in the hospital. Another advantage of the Stretta procedure is that antireflux surgery still can be performed in the case of failures. In conclusion, the Stretta procedure offers a minimally invasive, safe, and effective alternative to antireflux surgery for those patients who have GERD who are controlled unsatisfactorily on antisecretory medications, who are considering surgery, and who meet the anatomic criteria that make the procedure technically feasible and safe.     

Pepsin detection in patients with laryngopharyngeal reflux before and after fundoplication

Background  

Some patients with gastroesophageal reflux disease (GERD) suffer from laryngopharyngeal reflux (LPR). There is no reliable diagnostic test for LPR as there is for GERD. We hypothesized that detection of pepsin (a molecule only made in the stomach) in laryngeal epithelium or sputum should provide evidence for reflux of gastric contents to the larynx, and be diagnostic of LPR. We tested this hypothesis in a prospective study in patients with LPR symptoms undergoing antireflux surgery (ARS).     

Lower esophageal sphincter injections for the treatment of gastroesophageal reflux disease

Endoscopic therapies for the control of GERD offer the potential for significant symptomatic improvement while obviating many of the potential drawbacks associated with long-term medical therapy with acid suppressive or neutralizing medications and traditional antireflux surgery. Such endoluminal therapies are intended to be safe with a brief learning curve, easily administered in an outpatient setting without the need for general anesthesia, reproducible, and durable. LES injection therapies share the common theoretic method of action of bulking at the GEJ, leading to loss of sphincter compliance and distensibility. In the case of Enteryx, this sustained effect has been demonstrated to be secondary to chronic inflammation, fibrosis, and encapsulation resulting from a foreign body response to the injectate. Available data suggest that a majority of patients respond to LES injection therapies, as demonstrated by a decreasing usage of PPIs after implantation, the ability of many patients to terminate PPI use completely, and improved GERD-HRQOL scores. Responses seem reasonably durable in follow-up assessment up to 24 months post treatment. Although there may be some placebo effect associated with treatment, patients injected with Enteryx respond better than a control group of sham-treated subjects. Individuals treated with LES injections, however, represent a select subgroup of the overall population of refluxers. Study subjects, by and large, have had uncomplicated GERD with typical reflux symptoms of heartburn or regurgitation that have responded to PPIs. Patients who have severe anatomic derangements, such as esophageal strictures, persistent esophagitis, Barrett's esophagus, or sizeable hiatal hernias, are excluded from clinical trials, as are patients who have severe motility disorders or significant comorbid conditions. Similarly, patients who have responded poorly to PPIs and those who have primarily extraesophageal manifestations of GERD have not been studied. Outcomes to date have been assessed over the short to medium term; long-term outcome studies are lacking. The durability of response, therefore, remains largely unknown, as does the incidence of any long-term complications or side effects. A postmarket study to assess the long-term safety and durability of Enteryx therapy up to 36 months is under way, as required by the FDA, with a target enrollment of 300 patients. Detailed cost analyses have yet to be reported. Such data are important not only for comparing the various endoluminal therapies but also for comparison to standard medical therapy and antireflux surgery. At present, no randomized trials are completed that compare injection therapies to other accepted treatments of GERD. The ability to perform fundoplication safely and effectively after failed LES injection therapy is not well known, in that the number of subsequent surgical cases is small and the results largely anecdotal to date. Likewise, the ability to use LES injection as salvage therapy after failed fundoplication has not been tested. The data regarding endoluminal injection therapies are similar to those after endoscopic plication and radiofrequency application to the LES, in that a definite symptomatic response is observed, but the objective documentation of diminished esophageal acid exposure lags behind. Esophageal acid exposure is normalized in a minority of treated subjects and improved in an additional subgroup, whereas the rate of symptomatic response exceeds these objective improvements. The reasons for this disconnect are the subject of much speculation and controversy. A placebo effect has been discussed, but clearly more factors are at play. Perhaps a study effect also is important, in that patients enrolled in clinical trials for GERD control may be more likely to modify their dietary and lifestyle habits in an effort to bring about symptom relief. Maybe the understanding of the perception of reflux events is lacking, and these endoluminal therapies work mainly by altering the perception of reflux more than the amount of reflux itself. A recent technologic review of injection therapies for GERD concludes that the "data for Enteryx are as compelling as those of any other open-label evaluation of an endoluminal therapy for GERD". There is much to be learned about all endoluminal techniques. For now, LES injections are promising therapies lacking supportive evidence of long-term safety and efficacy. The available data justify their use only in patients who have GERD symptoms responsive to PPIs and who do not have significant comorbidities or complications associated with GERD. Whether or not the role of LES injection techniques will be expanded to include more complicated cases, patients who are partially responsive to PPIs, combination therapy with other endoluminal techniques, or salvage therapy after failed fundoplication awaits further study.     

Evaluation of Gastroesophageal Reflux Disease

Introduction

Gastroesophageal reflux disease (GERD) may present with heartburn, regurgitation, dysphagia, chronic cough, laryngitis, or even asthma. The clinical presentation of GERD is therefore varied and poses certain challenges to the physician, especially given the limitations of the diagnostic testing.

Discussion

The evaluation of patients with suspected GERD might be challenging. It is based on the evaluation of clinical features, objective evidence of reflux on diagnostic testing, correlation of symptoms with episodes of reflux, evaluation of anatomical abnormalities, and excluding other causes that might account for the presence of the patient’s symptoms.

Conclusions

The diagnostic evaluation should include multiple tests, in addition to a thorough clinical examination.

     

Antireflux surgery

Antireflux surgery (ARS) is appropriate and effective management for patients who have gastroesophageal reflux disease (GERD) refractory to medical management, who are on lifelong acid suppression, or who are experiencing side effects of the medical management. Over the past 2 decades, the operations have evolved from predominantly open thoracic approaches to a predominantly laparoscopic abdominal approach with similar, if not better, outcomes. The success of ARS in managing GERD lies largely in an understanding of GERD and its diagnosis, proper patient selection, sound surgical technique, and postoperative management.