Robotic Complex Fundoplication in Patients at High-Risk to Fail.

BACKGROUND: This study was undertaken to analyze our outcomes after robotic fundoplication for GERD in patients with failed antireflux procedures, with type IV (i.e., giant) hiatal hernias, or after extensive intra-abdominal surgery with mesh, and to compare our results to outcomes predicted by the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator and to national outcomes reported by NSQIP. METHODS: 100 patients undergoing robotic fundoplication for the aforementioned factors were prospectively followed. RESULTS: 100 patients, aged 67 (67 ± 10.3) years with body mass index (BMI) of 26 (25 ± 2.9) kg/m2 underwent robotic fundoplication for failed antireflux fundoplications (43%), type IV hiatal hernias (31%), or after extensive intra-abdominal surgery with mesh (26%). Operative duration was 184 (196 ± 74.3) min with an estimated blood loss of 24 (51 ± 82.9) mL. Length of stay was 1 (2 ± 3.6) day. Two patients developed postoperative ileus. Two patients were readmitted within 30 days for nausea.Nationally reported outcomes and those predicted by NSQIP were similar. When comparing our actual outcomes to predicted and national NSQIP outcomes, actual outcomes were superior for serious complications, any complications, pneumonia, surgical site infection, deep vein thrombosis, readmission, return to OR, and sepsis (P < 0.05); our actual outcomes were not worse for renal failure, deaths, cardiac complications, and discharge to a nursing facility. CONCLUSIONS: Our patients were not a selective group; rather they were more complex than reported in NSQIP. Most of our results after robotic fundoplication were superior to predicted and national outcomes. The utilization of the robotic platform for complex operations and fundoplications to treat patients with GERD is safe and efficacious.

Laparoscopic Toupet fundoplication for gastroesophageal reflux disease and hiatus hernia: proposal for standardization using the "critical view" concept.

Laparoscopic Toupet fundoplication has gained progressive consideration in the management of patients with gastroesophageal reflux disease and hiatus hernia. Previous studies showed equivalent results in terms of reflux control with lower rate of side effects compared to the Nissen fundoplication. However, multiple technical variations may account for the long-lasting reputation of decreased durability and poor long-term reflux control. Inspired by the "critical view" concept, a step-by-step laparoscopic Toupet fundoplication is described and illustrated. During the study period, 2012-2017, 348 consecutive patients underwent laparoscopic Toupet fundoplication according to a standardized procedure. A large hiatus hernia was present in 39% of patients, and 14% had volvulus of the intrathoracic stomach. Sixty-four (18.4%) patients had one or more previously failed antireflux procedures. The median follow-up was 37 months (range 12-61). The Gastroesophageal Reflux Disease Health-Related Quality of Life score significantly improved compared to baseline (p < 0.001), and 77% of patients were off proton-pump inhibitors. The proposed standardization of the Toupet fundoplication based on a "critical-view" concept may help to improve reproducibility, clinical outcomes, and teaching of this procedure.

Error traps and safety steps when performing a laparoscopic Nissen fundoplication.

Quality and safety have come to the forefront of the current healthcare environment over the past 10 years. Although all surgeons feel they perform safe operations with quality outcomes, these variables are being increasingly measured in today's healthcare world. The purpose of this article is to describe our thoughts about the error traps and safety steps when performing a laparoscopic Nissen fundoplication. Hopefully, adherence to these technical points will help prevent the need for a second operative procedure due to transmigration of the fundoplication wrap or the need for esophageal dilation postoperatively.

A novel strategy to initiate a peroral endoscopic myotomy program.

OBJECTIVES: The standard of care for achalasia remains laparoscopic Heller myotomy with partial fundoplication. Peroral endoscopic myotomy (POEM) has been introduced as an alternative, but safety and long-term comparative efficacy are not yet established. We report our experience in developing a POEM program using a novel hybrid approach. METHODS: We developed a hybrid approach to POEM with a POEM followed by laparoscopic evaluation, extension of the myotomy, if necessary, and partial fundoplication. We reviewed the results of the programme from April 2012 until May 2015. Starting in 2014, we began offering patients stand-alone POEM. Patient data were collected. Preoperative and postoperative Eckardt scores were compared. RESULTS: A total of 28 patients underwent POEM or POEM plus laparoscopic evaluation with partial fundoplication. Patient characteristics and perioperative and postoperative data were recorded. The median preoperative Eckardt score was 6 (range 4-11). The mean follow-up period was 136 days (range 41-330) and the median postoperative Eckardt score was 0 (range 0-6) at 6 weeks. Of our initial 10 patients, 6 required laparoscopic extension of the myotomy; 7 subsequent patients did not require an additional myotomy. Three patients who underwent POEM without laparoscopy continued to have dysphagia postoperatively. One patient had an attempted POEM that was aborted secondary to bleeding, and a standard laparoscopic modified Heller myotomy with partial fundoplication was performed. CONCLUSIONS: The excellent results of laparoscopic myotomy with partial fundoplication are challenging to duplicate during the initial adoption of a POEM approach. We present a program developed to steepen the learning curve and enhance patient safety while implementing this new procedure.

Training model for laparoscopic Heller and Dor fundoplication: a tool for laparoscopic skills training and assessment-construct validity using the GOALS score.

BACKGROUND: Laparoscopic training demands practice. The transfer of laparoscopic skills from training models to real surgical procedures has been proven. The global operative assessment of laparoscopic skills (GOALS) score is a 5-item global rating scale developed to evaluate laparoscopic skills by direct observation. This scale has been used to demonstrate construct validity of several laparoscopic training models. Here, we present a low-cost model of laparoscopic Heller-Dor for advanced laparoscopic training. The aim of this study was to determine the capability of a training model for laparoscopic Heller-Dor to discriminate between different levels of laparoscopic expertise. METHODS: The performance of two groups with different levels of expertise, novices (<30 laparoscopic procedures PGY1-2) and experts (>300 laparoscopic procedures PGY4-5) was assessed. All participants were instructed to perform two tasks (esophageal myotomy and fundoplication). All the performances were recorded in a digital format. A laparoscopic expert who was blinded to subject's identity evaluated the recordings using the GOALS score. Autonomy, one of the five items of GOALS, was removed since the evaluator and the trainee did not have interaction. The time required to finish each task was also recorded. Performance was compared using the Mann-Whitney U test (p < 0.05 was significant). RESULTS: Twenty subjects were evaluated: ten in each group, using the GOALS score. The mean total GOALS score for novices was 7.5 points (SD: 1.64) and 13.9 points (SD: 1.66) for experts (p < 0.05).The expert group was superior in each domain of the GOALS score compared to novices: depth perception (mean: 3.3 vs 2 p < 0.05), bimanual dexterity (mean 3.4 vs 2.1 p < 0.05), efficiency (mean 3.4 vs 1.7 p < 0.05) and tissue handling (mean 3.6 vs 1.7 p < 0.05). With regard to time, experts were superior in task 1 (mean 9.7 vs 14.9 min p < 0.05) and task 2 (mean 24 vs 47.1 min p < 0.05) compared to novices. CONCLUSIONS: The laparoscopic Heller-Dor training model has construct validity. The model may be used as a tool for training of the surgical resident.

EAES recommendations for the management of gastroesophageal reflux disease.

BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most frequent benign disorders of the upper gastrointestinal tract. Management of GERD has always been controversial since modern medical therapy is very effective, but laparoscopic fundoplication is one of the few procedures that were quickly adapted to the minimal access technique. The purpose of this project was to analyze the current knowledge on GERD in regard to its pathophysiology, diagnostic assessment, medical therapy, and surgical therapy, and special circumstances such as GERD in children, Barrett's esophagus, and enteroesophageal and duodenogastroesophageal reflux. METHODS: The European Association of Endoscopic Surgery (EAES) has tasked a group of experts, based on their clinical and scientific expertise in the field of GERD, to establish current guidelines in a consensus development conference. The expert panel was constituted in May 2012 and met in September 2012 and January 2013, followed by a Delphi process. Critical appraisal of the literature was accomplished. All articles were reviewed and classified according to the hierarchy of level of evidence and summarized in statements and recommendations, which were presented to the scientific community during the EAES yearly conference in a plenary session in Vienna 2013. A second Delphi process followed discussion in the plenary session. RESULTS: Recommendations for pathophysiologic and epidemiologic considerations, symptom evaluation, diagnostic workup, medical therapy, and surgical therapy are presented. Diagnostic evaluation and adequate selection of patients are the most important features for success of the current management of GERD. Laparoscopic fundoplication is the most important therapeutic technique for the success of surgical therapy of GERD. CONCLUSIONS: Since the background of GERD is multifactorial, the management of this disease requires a complex approach in diagnostic workup as well as for medical and surgical treatment. Laparoscopic fundoplication in well-selected patients is a successful therapeutic option.

The first nationwide evaluation of robotic general surgery: a regionalized, small but safe start.

BACKGROUND: The purpose of this study was to evaluate the outcomes of the most commonly performed robotic-assisted general surgery (RAGS) procedures in a nationwide database and compare them with their laparoscopic counterparts. METHODS: The Nationwide Inpatient Sample was queried from October 2008 to December 2010 for patients undergoing elective, abdominal RAGS procedures. The two most common, robotic-assisted fundoplication (RF) and gastroenterostomy without gastrectomy (RG), were individually compared with the laparoscopic counterparts (LF and LG, respectively). RESULTS: During the study, 297,335 patients underwent abdominal general surgery procedures, in which 1,809 (0.6 %) utilized robotic-assistance. From 2009 to 2010, the incidence of RAGS nearly doubled from 573 to 1128 cases. The top five RAGS procedures by frequency were LG, LF, laparoscopic lysis of adhesions, other anterior resection of rectum, and laparoscopic sigmoidectomy. Eight of the top ten RAGS were colorectal or foregut operations. RG was performed in 282 patients (0.9 %) and LG in 29,677 patients (99.1 %). When comparing RG with LG there was no difference in age, gender, race, Charlson comorbidity index (CCI), postoperative complications, or mortality; however, length of stay (LOS) was longer in RG (2.5 ± 2.4 vs. 2.2 ± 1.5 days; p < 0.0001). Total cost for RG was substantially higher ($60,837 ± 28,887 vs. $42,743 ± 23,366; p < 0.0001), and more often performed at teaching hospitals (87.2 vs. 50.9 %; p < 0.0001) in urban areas (100 vs. 93.0 %; p < 0.0001). RF was performed in 272 patients (3.5 %) and LF in 7,484 patients (96.5 %). RF patients were more often male compared with LF (38.2 vs. 32.3 %; p < 0.05); however, there was no difference in age, race, CCI, LOS, or postoperative complications. RF was more expensive than LF ($37,638 ± 21,134 vs. $32,947 ± 24,052; p < 0.0001), and more often performed at teaching hospitals (72.4 vs. 54.9 %; p < 0.0001) in urban areas (98.5 vs. 88.7 %; p < 0.0001). CONCLUSIONS: This nationwide study of RAGS exemplifies its low but increasing incidence across the country. RAGS is regionalized to urban teaching centers compared with conventional laparoscopic techniques. Despite similar postoperative outcomes, there is significantly increased cost associated with RAGS.

Standardization of surgical technique in antireflux surgery: the LOTUS Trial experience.

BACKGROUND: To date, it has been difficult to compare medical therapy for gastroesophageal reflux disease with that of surgical management from a scientific viewpoint, mainly because of the lack of standardization of the operative technique. This study was designed to identify a methodology for standardization of surgical technique and to measure the effectiveness of this standardization. METHODS: Surgeons contributing to a major international multicenter trial comparing optimum medical therapy with surgical therapy for treatment of gastroesophageal reflux attempted to optimize their surgical techniques so that a realistic comparison could be made that may aid clinical decision-making. The surgeons met, shared their techniques using video, and produced a standardized set of criteria for the surgical centers and a common operative technique. Data collection methods ensured accuracy of the records of the procedure applied and the data were analyzed for consistency with set surgical standards. RESULTS: There was a high degree of conformity (>95%) between the recommended method of performing a Nissen fundoplication as defined in the trial protocol, and variations were restricted to isolated individuals. The operations were completed without mortality, few conversions, and with very low postoperative morbidity. CONCLUSIONS: This study has shown that, contrary to commonly held belief, surgeons are able to standardize their work for the purposes of measuring the outcome of an operative procedure within the context of a randomized, controlled trial.

Anterior fundoplication decreases esophageal clearance in patients undergoing Heller myotomy for achalasia.

BACKGROUND: Anterior fundoplication (AF) following laparoscopic Heller myotomy (LHM) for achalasia may prevent esophageal leaks and gastroesophageal reflux but cause dysphagia. Our study attempts to determine the effect of AF on esophageal leaks, nuclear medicine esophageal clearance (EC), symptom frequency (SF), and Van Trappen symptom scores (SS) for dysphagia, regurgitation, and heartburn. METHODS: Between 1995 and 2004, pre- and postoperative (2-12 months) EC, SF, and SS scores were compared in 95 patients undergoing LHM for achalasia with AF (n = 71) and without (n = 24) AF. RESULTS: There were no leaks or deaths. Laparoscopic Heller myotomy decreased the frequency of postoperative dysphagia, regurgitation, and heartburn with AF (96% preoperation versus 6% postoperation, 94% versus 3%, 58% versus 6%) (p = 0.001) and without AF (100% versus 0%, 83% versus 0%, 50% versus 4%) (p = 0.001). Laparoscopic Heller myotomy improved all SS in both groups. There was no difference between postoperative dysphagia (1.38 +/- 0.64 versus 1.17 +/- 38) p = 0.06, regurgitation (1.17 +/- 51 versus 1.04 +/- 0.20) p = 0.08, and heartburn (1.29 +/- 62 versus 1.53 +/- 0.80) p = 0.185 scores between the AF and no-AF group, respectively. There is a trend toward improvement in dysphagia and regurgitation in the no-AF group. Laparoscopic Heller myotomy improved EC in the supine and upright positions in both groups of patients (p = 0.001). There was an improved mean change in EC (10 min upright) in the no-AF group versus the AF group (50.7% +/- 30.8 versus 29.7% +/- 30.2) p = 0.004. CONCLUSIONS: Laparoscopic Heller myotomy improves esophageal transit and the frequency and severity of dysphagia, heartburn, and regurgitation in a safe manner. Patients without AF show a statistically better upright EC with a trend toward improved dysphagia and regurgitation.

Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments.

BACKGROUND: The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD. SEARCH STRATEGY: In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD). DATA COLLECTION AND ANALYSIS: All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. MAIN RESULTS AND AUTHORS' CONCLUSION: Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.

Laparoscopic Nissen-Rossetti fundoplication with routine use of intraoperative endoscopy and manometry: technical aspects of a standardized technique.

BACKGROUND: Several different ways of fashioning a total fundoplication lead to different outcomes. This article addresses the technical details of the antireflux technique we adopted without modifications for all patients with GERD beginning in 1972. In particular it aims to discuss the relation between the mechanism of function of the wrap and the physiology of the esophagus. METHODS: The study population consisted of 380 patients affected by GERD with a 1-year minimum of follow-up who underwent laparoscopic Nissen-Rossetti fundoplication by a single surgeon. RESULTS: No conversion to open surgery and no mortality occurred. Major complications occurred in 4 patients (1.1%). Follow-up (median 83 months; range: 1-13 years) was achieved in 96% of the patients. Ninety-two percent of the patients were satisfied with the results of the procedure and would undergo the same operation again. Postoperative dysphagia occurred in 3.5% of the patients, and recurrent heartburn was observed in 3.8%. CONCLUSIONS: Laparoscopic Nissen-Rossetti fundoplication with the routine use of intraoperative manometry and endoscopy achieved good outcomes and long-term patient satisfaction with few complications and side-effects. Appropriate preoperative investigation and a correct surgical technique are important in securing these results.

Long-term outcomes confirm the superior efficacy of extended Heller myotomy with Toupet fundoplication for achalasia.

BACKGROUND: The standard Heller myotomy (SM) for achalasia extends 1 to 2 cm on to the stomach. The authors perform an extended myotomy (EM) (>3 cm) with the goal of reducing postoperative dysphagia. This study examines the long-term efficacy and durability of EM compared with SM. METHODS: Patients with achalasia who underwent a laparoscopic Heller myotomy were identified from a prospective database that includes symptom evaluation and results of esophageal functional studies. From September 1994 to August 1998, the authors performed SM with Dor fundoplication, and from September 1998 through 2003, they performed EM with Toupet fundoplication. In 2001, they performed a telephone survey of all available patients. This was repeated in 2005 for the EM group. The survey included scales of symptom frequency (0 [never], 1 [once per month], 2 [once per week], 3 [once per day], 4 [more than once per day]) and severity (0 [no symptoms] to 10 [symptoms equal to preoperative state]) as well as the need to undergo postoperative intervention for dysphagia. RESULTS: For this study, 52 patients underwent SM with Dor fundoplication (median follow-up period, 46 +/- 24 months), and 63 patients underwent EM with Toupet fundoplication (median follow-up period, 45 +/- 17 months. Postoperative dysphagia severity was significantly better in the EM group (4.8 +/- 2.3 vs 3.1 +/- 2.6; p < 0.005). There was no significant difference in postoperative heartburn frequency, esophageal acid exposure, or lower esophageal sphincter pressure. In the SM group, 9 patients (17%) required reintervention for dysphagia: 14 endoscopic interventions for 5 patients (10%) and reoperation for 4 patients. Three patients (5%) in the EM group required reintervention for dysphagia: one endoscopic intervention each and no reoperations (p < 0.05). A total of 30 patients in the EM group were contacted in both 2001 (median follow-up period, 19 +/- 11 months) and 2005 (median follow-up period, 63 +/- 10 months). There was no significant change over time in dysphagia severity (2.6 +/- 1.9 vs 3.7 +/- 2.0; p = 0.19). CONCLUSIONS: For the treatment of achalasia, EM with Toupet fundoplication provides excellent durable dysphagia relief that is superior to SM with Dor fundoplication.

Five-year results of laparoscopic Toupet fundoplication as the primary surgical repair in GERD patients: is it durable?

INTRODUCTION: Most surgeons operate on gastroesophageal reflux disease (GERD) patients using the concept of "tailored approach," which depends on esophageal motility. We have abandoned this concept and performed laparoscopic Toupet fundoplication in all patients suffering from GERD, independent of their esophageal motility. METHODS: In a prospective trial we have assessed and evaluated our 5-year results of the first 100 consecutive patients treated with laparoscopic Toupet fundoplication. All patients were evaluated preoperatively by endoscopy and 24-h pH manometry. The patients were followed up clinically 1, 2, 6, 12 and 60 months postoperatively. The course of clinical DeMeester score, appearance and treatment of wrap-related side-effects as well as long-term outcome and patient satisfaction were evaluated. RESULTS: The 5-year follow-up rate was 87%. Laparoscopic Toupet fundoplication achieved a 5-year healing rate of GERD in 85%. Of all operated patients, 3.5% had to be reinstalled on a regular PPI treatment because of postoperative GERD reappearance. The median clinical DeMeester score decreased from 4.27 +/- 1.5 points preoperatively to 0.47 +/- 0.9 points 5 years postoperatively (p < 0.0005). Because of persistent postoperative dysphagia, 5% of the patients required endoscopic dilatation therapy. Persistent postoperative gas-bloat syndrome occurred in 1.1%. Wrap dislocation was identified in 3.4% of patients. Reoperation rate was 5%. Total morbidity rate was 19.5% and operative related mortality rate was 0%. Overall, 96.6% of patients were pleased with their outcome at late follow-up, and 95.4% of patients stated they would consider undergoing laparoscopic fundoplication again if necessary. CONCLUSION: Our long-term results showing a low recurrence and morbidity rate of laparoscopic Toupet fundoplication encourage us to continue to perform this procedure as the primary surgical repair in all GERD patients, independent of their esophageal motility. Laparoscopic Toupet fundoplication has proven to be a safe and successful therapeutic option in GERD patients.