Randomized Trial of Laparoscopic Nissen Versus Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15 to 20 years.

OBJECTIVE: To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication. SUMMARY BACKGROUND DATA: Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fundoplications have been proposed. Previously reports from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures. METHODS: One hundred seven participants were randomized to Nissen versus anterior 180-degree partial fundoplication. Fifteen to 20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0 to 10 analog scores and yes/no questions to determine reflux symptoms, side-effects, and satisfaction with surgery. RESULTS: After anterior fundoplication heartburn (mean score 3.2 vs 1.4, P = .001) and proton pump inhibitor use (41.7% vs 17.1%, P = .023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, P = .015), and better ability to belch (84.2% vs 65.9%, P = .030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, P = .444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision after anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision after Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1). CONCLUSIONS: At 15 to 20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control versus more side-effects after Nissen fundoplication.

Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.

OBJECTIVE: To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair. SUMMARY OF BACKGROUND DATA: Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair. METHODS: Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years. RESULTS: 126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh. CONCLUSIONS: No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.

Laparoscopic repair of very large hiatus hernia with sutures versus absorbable mesh versus nonabsorbable mesh: a randomized controlled trial.

OBJECTIVE: Determine whether absorbable or nonabsorbable mesh in repair of large hiatus hernias reduces the risk of recurrence, compared with suture repair. BACKGROUND: Repair of large hiatus hernia is associated with radiological recurrence rates of up to 30%, and to improve outcomes mesh repair has been recommended. Previous trials have shown less short-term recurrence with mesh, but adverse outcomes limit mesh use. METHODS: Multicentre prospective double blind randomized controlled trial of 3 methods of repair: sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome-hernia recurrence assessed by barium meal radiology and endoscopy at 6 months. Secondary outcomes-clinical symptom scores at 1, 3, 6, and 12 months. RESULTS: A total of 126 patients enrolled: 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Among them, 96.0% were followed up to 12 months, with objective follow-up data in 92.9%. A recurrent hernia (any size) was identified in 23.1% after suture repair, 30.8% after absorbable mesh, and 12.8% after nonabsorbable mesh (P = 0.161). Clinical outcomes were similar, except less heartburn at 3 and 6 months and less bloating at 12 months with nonabsorbable mesh; more heartburn at 3 months, odynophagia at 1 month, nausea at 3 and 12 months, wheezing at 6 months; and inability to belch at 12 months after absorbable mesh. The magnitudes of the clinical differences were small. CONCLUSIONS: No significant differences were seen for recurrent hiatus hernia, and the clinical differences were unlikely to be clinically significant. Overall outcomes after sutured repair were similar to mesh repair.

Prospective randomized trial of argon plasma coagulation ablation versus endoscopic surveillance of Barrett's esophagus in patients treated with antisecretory medication.

Argon plasma coagulation (APC) has been used to ablate Barrett's esophagus, however, its role in the management of non-dysplastic Barrett's esophagus is uncertain. The purpose of this study is to determine the efficacy of endoscopic argon plasma coagulation (APC) for ablation of Barrett's esophagus in a prospective randomized controlled trial in two university teaching hospitals. Fifty-seven patients using proton pump inhibitor (PPI) medication and with Barrett's esophagus were randomized to undergo either ablation using endoscopic argon plasma coagulation (APC) or ongoing surveillance. Fifty-one patients underwent endoscopy at 12 months. Endoscopic argon plasma coagulation (APC) versus surveillance endoscopy was studied. Endoscopy and histopathological appearances of Barrett's esophagus at 12 months follow-up was also studied. Initially, at least 95% ablation of the metaplastic mucosa was achieved in 25 of the 26 treated patients. At 12 months, 14 of 23 APC patients had at least 95% regression, and nine of 23 had complete regression of Barrett's esophagus. No surveillance patient had more than 95% regression. The length of Barrett's esophagus shortened significantly after APC (mean 3.0 vs. 0.5 cm). Significant regression of Barrett's esophagus follows ablation with APC, although complete regression was achieved in less than half. The role of APC ablation of non-dysplastic Barrett's esophagus remains uncertain.

Impact of gender and age on the long-term outcome of laparoscopic fundoplication.

BACKGROUND: It has been suggested that gender and age could be factors that influence the likelihood of success following antireflux surgery, and our anecdotal impression has been that the outcome following Nissen fundoplication in older women is often disappointing. If correct, characterization of the extent of any differences in outcome might help patient selection and, hence, surgical outcomes. Therefore, in this study we investigated the impact of gender and age on longer-term clinical outcomes following laparoscopic fundoplication. METHODS: Perioperative and follow-up data from patients undergoing laparoscopic fundoplication in our departments have been collected prospectively and stored in a database. From the database, patients who had undergone either an anterior 180 degrees partial or 360 degrees total laparoscopic fundoplication for gastroesophageal reflux and completed 5 years clinical follow-up were identified. Patients were classified according to gender and age, and outcome data were analyzed to determine differences. Analog scales of 0-10 were used to determine symptoms of heartburn and dysphagia and overall satisfaction. RESULTS: Seven hundred three patients were studied (58% males). Females were less satisfied with the outcome (score = 7.8 +/- 2.8 vs. 8.4 +/- 2.5, P = 0.0036), and had higher scores for heartburn (2.0 +/- 2.7 vs. 1.2 +/- 2.2; P = 0.0001) and dysphagia for solid food (2.7 +/- 2.9 vs. 2.0 +/- 2.5, P = 0.0049) compared to males. Revisional procedures were undertaken more frequently in females (15.5% vs. 8.4%, P = 0.0038). Age had no impact on any clinical outcome. CONCLUSIONS: While the outcome for laparoscopic fundoplication is not influenced by age, the outcome for women is poorer than in males.

Laparoscopic anterior 180 degrees partial fundoplication: five-year results and beyond.

HYPOTHESIS: Laparoscopic anterior 180 degrees partial fundoplication provides good long-term relief for symptoms of gastroesophageal reflux disease and is associated with few adverse effects. DESIGN: Prospectively evaluated case series. SETTING: University teaching hospital. PATIENTS: The late clinical outcome was determined for all patients who had undergone a laparoscopic anterior 180 degrees partial fundoplication by us between August 1, 1993, and November 30, 1999. INTERVENTIONS: Long-term (>/=5 years') follow-up after laparoscopic anterior 180 degrees partial fundoplication was obtained using a structured questionnaire. MAIN OUTCOME MEASURES: Overall satisfaction and the symptoms of heartburn and dysphagia were assessed using analog scales, and the presence or absence of other adverse outcomes was also determined. RESULTS: One hundred seventeen procedures were performed. The outcome at 5 to 11 years' (mean, 6.4 years') follow-up was determined for 113 patients (97%). Twelve patients (11%) died of unrelated causes during follow-up, and 1 patient underwent esophagectomy. Further surgery was undertaken in 12 patients (11%): 8 for recurrent reflux, 3 for a symptomatic hiatal hernia, and 1 for dysphagia. For 100 patients with clinical outcome data at late follow-up, gastroesophageal reflux symptoms were significantly improved following surgery and were well controlled in 80 patients. The incidence and severity of dysphagia were reduced after surgery. Normal belching was preserved in 91 patients, and almost all patients were able to eat normally. The overall outcome of surgery was rated as satisfactory, with 95 patients reporting that they considered their original decision to undergo surgery correct. CONCLUSIONS: Laparoscopic anterior 180 degrees partial fundoplication is an effective procedure for the surgical treatment of gastroesophageal reflux and is associated with a high rate of patient satisfaction at late follow-up. Compared with Nissen fundoplication, however, it is likely to be associated with a higher risk of recurrent reflux, although this is balanced by a lower rate of adverse effects.

Proximal anastomosis using the OrVil circular stapler in major upper gastrointestinal surgery.

Anastomoses in major upper gastrointestinal surgery can be technically demanding, especially handsewn anastomoses traversing the diaphragmatic hiatus. The OrVil stapler is a unique circular stapler that allows rapid creation of various upper gastrointestinal anastomoses in technically challenging circumstances, particularly if additional proximal clearance is desirable. Little is reported in the literature regarding its outcomes and complication rates. In this 'How I do It' article, we describe our technique and experience with the OrVil in major upper gastrointestinal surgery.

Anterior 180-degree partial fundoplication: a 16-year experience with 548 patients.

BACKGROUND: Previous randomized studies have shown that laparoscopic anterior 180-degree partial fundoplication achieves good control of gastroesophageal reflux, and with fewer side effects compared with Nissen fundoplication. Late clinical outcomes, however, remain uncertain, and outcomes from large series have not been reported. STUDY DESIGN: From August 1993 to November 2009, we performed 548 laparoscopic anterior 180-degree partial fundoplications. Perioperative data and clinical outcomes were determined prospectively using a structured questionnaire that evaluated heartburn, dysphagia, and satisfaction with clinical outcomes. Early and late clinical outcomes were evaluated in the overall group, and separately for patients with and without a large hiatus hernia. RESULTS: Five hundred and forty-eight patients (243 men, 305 women) underwent surgery, 380 primarily for gastroesophageal reflux and 168 with a large hiatus hernia. Fourteen patients (2.6%) underwent reoperation within 7 days of their original procedure, and later reoperation was required in 17 (3.1%) patients. Patients undergoing surgery for a large hiatus hernia were more likely to have a postoperative complication develop (13.7% versus 2.1%), more likely to undergo surgical revision in the first postoperative week (6.0% versus 1.1%), and less likely to undergo later revision (0.6% versus 4.2%), compared with patients undergoing surgery predominantly for reflux. Three-month, 1-, 5-, and 10-year follow-up was available for 511, 462, 233, and 89 patients, respectively. Heartburn and dysphagia scores were significantly improved at all postoperative time points compared with preoperative scores (p < 0.0001). Overall satisfaction with the outcomes of surgery remained stable across 10 years of follow-up. CONCLUSIONS: Laparoscopic anterior 180-degree partial fundoplication is an effective and durable alternative to Nissen fundoplication for the surgical treatment of gastroesophageal reflux.

Perioperative risk analysis for acute respiratory distress syndrome after elective oesophagectomy.

BACKGROUND: Acute respiratory distress syndrome (ARDS) is a major contributor to respiratory morbidity and mortality after oesophagectomy. Several pre-, intra- and post-operative factors are thought to predispose to its development in the post-oesophagectomy period. The aim of this study was to determine factors predisposing to ARDS in the post-oesophagectomy period. METHODS: A total of 112 patients who underwent elective oesophagectomy for oesophageal cancer (gastro-oesophageal adenocarcinoma and high-grade dysplasia, 93; oesophageal squamous cell carcinoma, 16; oesophageal oat cell tumour, 1; oesophageal anaplastic carcinoma, 1; oesophageal colloid carcinoma, 1) between 1 January 2003 and 31 December 2006 formed the study group in this retrospective study. The pre-, intra and post-operative data for these patients (male : female = 89:23, mean age 60.8 years) were collected from an oesophagectomy database and hospital medical records. RESULTS: The incidence of ARDS was 13%. The in-hospital mortality among ARDS cases was 20% and 1-year mortality was 40%. Various factors such as preoperative chronic respiratory disease (P-value = 0.000, odds ratio = 17.76), smoking pack-years (P-value = 0.045, odds ratio = 1.02), abnormal preoperative forced expiratory volume in 1 s (P-value = 0.009, odds ratio = 7.97), high percentage of oxygen in inspired air (P-value = 0.041, odds ratio = 1.24) and use of perioperative inotropes (P-value = 0.021, odds ratio = 4.26) were associated with ARDS. CONCLUSIONS: Preoperative physiological status as indicated by a preoperative history of chronic respiratory disease and preoperative pulmonary function influenced the post-operative outcome in our patients. The use of perioperative inotropes suggests perioperative cardiorespiratory instability, and could also predispose to the development of ARDS in the post-operative period.

The effect of obesity on the outcome of laparoscopic antireflux surgery.

BACKGROUND: Obesity has long been considered to be a predisposing factor for gastroesophageal reflux. It is also thought to predispose patients to a poorer clinical outcome following antireflux surgery. This study examined the effect of body mass index (BMI) on clinical outcomes following laparoscopic antireflux surgery. METHODS: Patients were included if they had undergone a laparoscopic fundoplication, their presurgical BMI was known, and they had been followed for at least 12 months after surgery. The clinical outcome was determined using a structured questionnaire, and this was applied yearly after surgery. Patients were divided into four groups according to BMI: normal weight (BMI < 25), overweight (BMI 25-29.9), obese (BMI 30-34.9), and morbidly obese (BMI > or = 35). The most recent clinical outcome data was analyzed for each BMI group. RESULTS: Patients, 481, were studied. One hundred three (21%) had a normal BMI, 208 (43%) were overweight, 115 (24%) were obese, and 55 (12%) were morbidly obese. Mean follow-up was 7.5 years. Conversion to an open operation and requirement for revision surgery were not influenced by preoperative weight. Operating time was longer in obese patients (mean 86 vs 75 min). Clinical outcomes improved following surgery regardless of BMI. CONCLUSIONS: Preoperative BMI does not influence the clinical outcome following laparoscopic antireflux surgery. Obesity is not a contraindication for laparoscopic fundoplication.

Laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: long-term results of a randomized trial.

BACKGROUND: Postoperative dysphagia in patients after Nissen fundoplication might be related to the technique used for the closure of the esophageal hiatus. METHODS: A total of 102 patients with gastroesophageal reflux were randomized to undergo laparoscopic Nissen fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. RESULTS: Clinical data at 5 years after surgery were available for 96% of patients enrolled in the trial. There was no significant difference between the 2 techniques for symptoms of dysphagia at the 5-year follow-up evaluation, although more patients who underwent posterior hiatal repair underwent further surgery for dysphagia-related symptoms (8 vs 2). Better control of heartburn was achieved in patients in the anterior hiatal repair group. Patients from both groups were equally satisfied with the overall outcome after surgery. CONCLUSIONS: At the 5-year follow-up evaluation, there was no significant difference in dysphagia between anterior closure and posterior hiatal repair.

Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes.

BACKGROUND: Although laparoscopic Nissen fundoplication is an effective procedure for the treatment of gastroesophageal reflux, in some patients it is followed by troublesome side effects, such as dysphagia, abdominal bloating, and inability to belch. It has been claimed that dividing the short gastric blood vessels during laparoscopic Nissen fundoplication minimizes the risk of these problems. We have previously reported the 6-month and 5-year outcomes from a randomized trial, which have shown no advantages after division of these vessels. In this study, we determined the longer-term (10 years) outcomes from this trial. METHODS: From May 1994 to October 1995, 102 patients with gastroesophageal reflux disease who underwent a laparoscopic Nissen fundoplication were entered into this randomized trial (vessels divided in 50, not divided in 52). At 10-year follow-up, 88 patients provided clinical follow-up information. Follow-up was obtained by telephone interview conducted by an independent and blinded investigator who applied a standardized questionnaire. RESULTS: At 10-year follow-up no significant differences between the 2 groups could be identified. Heartburn, dysphagia, and overall satisfaction were similar for both study groups. CONCLUSIONS: The 10-year clinical outcomes from this trial have shown no benefit for division of the short gastric vessels during laparoscopic Nissen fundoplication.

Laparoscopic Nissen fundoplication: clinical outcomes at 10 years.

BACKGROUND: Laparoscopic Nissen fundoplication is now the most common operative procedure for treatment of gastroesophageal reflux disease, although longterm clinical outcomes after this procedure remain uncertain. STUDY DESIGN: Outcomes for 250 patients who underwent Nissen (total) fundoplication at least 10 years ago (September 1991 to August 1995) were determined prospectively using a structured questionnaire that evaluated clinical symptom scores for heartburn, dysphagia, and satisfaction with clinical outcomes. RESULTS: Clinical followup data for at least 10 years (120 to 167 months) after operation were available for 226 patients, an additional 21 patients had died, making outcomes for 247 patients (99%). Of the three (1%) remaining patients, one was lost to followup and dementia developed in two. One hundred eighty-seven (83%) patients were highly satisfied with the clinical outcomes. One hundred eighty-nine (84%) had good or excellent control of heartburn. Symptom scores for heartburn, dysphagia, and overall satisfaction were unchanged from 5-year followup data. Forty-two (17%) patients underwent revision operations, 28 (22%) were in the first 125 patients and 14 (11%) in the subsequent 125 patients. Antireflux medication use increased gradually, resulting in 47 (21%) patients using medication at 10 years. Of 21 deaths, 1 was postoperative and the remaining 20 were similar to that predicted for a matched population. A high preoperative heartburn score correlated with high patient satisfaction and lower dysphagia score at 10 or more years (p = 0.038 and p = 0.041, respectively). CONCLUSIONS: Laparoscopic Nissen fundoplication is an effective longterm treatment for gastroesophageal reflux disease.

Randomized trial of argon plasma coagulation versus endoscopic surveillance for barrett esophagus after antireflux surgery: late results.

OBJECTIVE: To determine the efficacy of endoscopic argon plasma coagulation (APC) for ablation of Barrett esophagus. SUMMARY BACKGROUND DATA: APC has been used to ablate Barrett esophagus. However, the long-term outcome of this treatment is unknown. This study reports 5-year results from a randomized trial of APC versus surveillance for Barrett esophagus in patients who had undergone a fundoplication for the treatment of gastroesophageal reflux. METHODS: Fifty-eight patients with Barrett esophagus were randomized to undergo either ablation using APC or ongoing surveillance. At a mean 68 months after treatment, 40 patients underwent endoscopy follow-up. The efficacy of treatment, durability of the neosquamous re-epithelialization, and safety of the procedure were determined. RESULTS: Initially, at least 95% ablation of the metaplastic mucosa was achieved in all treated patients. At the 5-year follow-up, 14 of 20 APC patients continued to have at least 95% of their previous Barrett esophagus replaced by neosquamous mucosa, and 8 of these had complete microscopic regression of the Barrett esophagus. Five of the 20 surveillance patients had more than 95% regression of their Barrett esophagus, and 4 of these had complete microscopic regression (1 after subsequent APC treatment). The length of Barrett esophagus shortened significantly in both study groups, although the extent of regression was greater after APC treatment (mean 5.9-0.8 cm vs. 4.6-2.2 cm). Two patients who had undergone APC treatment developed a late esophageal stricture, which required endoscopic dilation, and 2 patients in the surveillance group developed high-grade dysplasia during follow-up. CONCLUSIONS: Regression of Barrett esophagus after fundoplication is more likely, and greater in extent, in patients who undergo ablation with APC. In most patients treated with APC the neosquamous mucosa remains stable at up to 5-year follow-up. The development of high-grade dysplasia only occurred in patients who were not treated with APC.

Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up.

OBJECTIVE: To determine whether division of the short gastric vessels at laparoscopic fundoplication confers long-term clinical benefit to patients. SUMMARY BACKGROUND DATA: Dividing the short gastric vessels during surgery for gastroesophageal reflux is controversial. This prospective randomized study was designed to determine whether there is a benefit in terms of patient outcome at a minimum of 5 years after primary surgery. METHODS: Between May 1994 and October 1995, 102 patients undergoing a laparoscopic Nissen fundoplication were randomized to have their short gastric vessels either divided or left intact. By September 2000, 99 (50 no division, 49 division) patients were available for follow-up, and they all underwent a detailed telephone interview by an independent and masked investigator. RESULTS: There were no significant differences between the groups at 5 years of follow-up in terms of the incidence of epigastric pain, regurgitation, odynophagia, early satiety, inability to belch, anorexia, nausea, vomiting, nocturnal coughing, and nocturnal wheezing. There was also no difference between the groups in the incidence of heartburn when determined by either yes/no questioning or a 0-to-10 visual analog scale. There was no difference between the groups in terms of the incidence and severity of dysphagia determined by yes/no questioning, 0-to-10 visual analog scales, or a composite dysphagia score. There was a significantly increased incidence of flatus production and epigastric bloating and a decreased incidence of ability to relieve bloating in patients who underwent division of the short gastric vessels. CONCLUSIONS: Division of the short gastric vessels during laparoscopic Nissen fundoplication does not improve any measured clinical outcome at 5 years of follow-up and is associated with an increased incidence of "wind-related" problems.