Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease

Background

Magnetic sphincter augmentation (MSA) has emerged as an alternative surgical treatment of gastroesophageal reflux disease (GERD). The safety and efficacy of MSA has been previously demonstrated, although adequate comparison to Nissen fundoplication (NF) is lacking, and required to validate the role of MSA in GERD management.

Methods

A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1 year for the overall group and for a propensity-matched group.

Results

A total of 415 patients (201 MSA and 214 NF) underwent surgery. The groups were similar in age, gender, and GERD-HRQL scores but significantly different in preoperative obesity (32 vs. 40 %), dysphagia (27 vs. 39 %), DeMeester scores (34 vs. 39), presence of microscopic Barrett’s (18 vs. 31 %) and hiatal hernia (55 vs. 69 %). At a minimum of 1-year follow-up, 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores (pre to post: 21–3 and 19–4). MSA patients had greater ability to belch (96 vs. 69 %) and vomit (95 vs. 43 %) with less gas bloat (47 vs. 59 %). Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of MSA. Mild dysphagia was higher for MSA (44 vs. 32 %). Resumption of daily PPIs was higher for MSA (24 vs. 12, p = 0.02) with similar patient-reported satisfaction rates.

Conclusions

MSA for uncomplicated GERD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared to propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management.

     

Risk factors for complications of laparoscopic Nissen fundoplication

BACKGROUND: Although the rate of complications from laparoscopic Nissen fundoplication is low and the adverse postoperative sequelae are well known, both are disturbing for the patient. Identifying risk factors could be helpful in the better selection of patients for this procedure. METHODS: A retrospective review of 126 patients with a mean follow-up period of 3.5 years was conducted. The patients' demographics, pre- and postoperative symptoms, and outcomes were analyzed and compared. RESULTS: Three groups of patients were distinguished: (group 1) 9 patients with intraoperative complications (5 with perforation, 3 with hemorrhage, 1 with pneumothorax); (group 2) 16 patients with postoperative complications (5 with severe dysphagia, 4 with failure, 2 with pneumonia, 2 with incisional hernia, 1 with intestine perforation, 1 with fundoplication herniation, 1 with infection, 1 with gastric ulcer); and (group 3) 101 patients without any complications. The patients'demographics, preoperative symptoms, and preoperative studies were comparable in all three groups. The body mass index (BMI) was significantly higher (p < 0.05) statistically in group 1 (32.4 kg/m2) and group 2 (33.6 kg/m2) than in group 3 (28.7 kg/m2). However, the Visick grade and the subjective outcome were similarly good in all three groups. CONCLUSIONS: Although preoperative studies and symptoms do not seem to predict complications of laparoscopic Nissen fundoplication, patients with an increased BMI were at increased risk for complications in this study. Therefore, such patients should be counseled appropriately regarding the greater likelihood of intraoperative and postoperative complications.     

Conventional versus robot-assisted laparoscopic Nissen fundoplication: a comparison of postoperative acid reflux parameters

Background

Laparoscopic Nissen fundoplication (LNF) is a technically demanding surgical procedure designed to cure gastroesophageal reflux disease (GERD). It represents an alternative to life-long medical therapy and the only recommended treatment modality to overcome refractoriness to proton pump inhibitor (PPI) therapy. The recent development of robotic systems prompted evaluation of their use in antireflux surgery. Between 1997 and 2000, in a PPI-responsive series we found postoperative normalization of esophageal acid exposure time (EAET) in most but not all cases. Between 2007 and 2009, in a PPI-refractory series we found postoperative normalization of EAET in all cases. We decided to analyze retrospectively our prospectively collected data to evaluate whether differences other than the conventional or robot-assisted technique could justify postoperative differences in acid reflux parameters.

Methods

Baseline demographic, endoscopic, and manometric parameters were compared between the two series of patients, as well as postoperative manometric and acid reflux parameters.

Results

There were no significant differences in the baseline demographic, endoscopic, and manometric characteristics between the two groups of patients. The median lower esophageal sphincter tone increased significantly, and the median EAET decreased significantly after conventional as well as after robot-assisted LNF. The median postoperative EAET was significantly lower in the robot-assisted (0.2%) than in the conventional LNF group (1%; P?=?0.001). Abnormal EAET values were found in 6 of 44 (14%) and in 0 of 44 cases after conventional and robot-assisted LNF, respectively (P?=?0.026).

Conclusions

Robot-assisted LNF provided a significant gain in postoperative acid reflux parameters compared with the conventional technique. In a challenging clinical setting, such as PPI-refractoriness, in which the efficacy of endoscopic or pharmacological treatment modalities is only moderate, even a small therapeutic gain can be clinically relevant. In centers where robot-assisted LNF is available, it should be preferred to conventional LNF in PPI-refractory GERD.     

A comparison of laparoscopic Toupet versus Nissen fundoplication in gastroesophageal reflux disease

BACKGROUND AND AIMS: Laparoscopic Nissen fundoplication is used very frequently but may lead to postoperative bloating, inability to belch, and dysphagia. Partial wrapping has been reported to be equally effective but associated with fewer unfavorable postoperative symptoms. The aim of this retrospective analysis was to compare the results of a 270-degree wrap (Toupet, T) and a 360-degree wrap (Nissen, N) in patients with gastroesophageal reflux disease (GERD). PATIENTS/METHODS: A total of 162 patients with severe GERD and/or hiatal hernia underwent laparoscopic antireflux surgery between January 1997 and December 2000. All patients were assigned to the T group before January 2000; after January 2000, they were assigned to either the T or the N group depending on preexisting motility disorders. The pre- and postoperative gastrointestinal quality of life index (GIQLI) was assessed. RESULTS: A total of 122 patients were treated using the T procedure, and 40 patients underwent N fundoplication; 124 patients (77%) had a lower esophageal sphincter (LES) pressure of less than 15 mmHg, and 34 (21%) had a low esophageal body peristaltic pressure of less than 35 mm Hg. All of the latter 34 had undergone partial fundoplication. The average operation time was 140 +/- 5 min in the T group and 118 +/- 6 min in the N group ( P=0.03). Postoperative hospitalization averaged 3.8 days in the T group and 3.4 days in the N group. Operative complications only occurred in the T group (2%), and none of the patients died. No statistical difference was seen preoperatively or at follow-up (mean 19 months; range 4-36 months) between the quality of life score after partial versus complete wrapping (88 and 123 in the T group, 87 and 118 in the N group preoperatively and at follow-up, respectively). CONCLUSIONS: Both partial and complete wrapping offer an effective form of therapy for reflux disease with over 85% patient satisfaction.     

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes

Background  

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF).     

Laparoscopic Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD)

Background: A prospective study was conducted to evaluate the physiologic and clinical consequences of laparoscopic Nissen fundoplication (LNF), using strict indications for surgery. Methods: From 1992 to 1997, 50 patients underwent LNF. Indications for operative treatment were either failure of conservative treatment or foresight to see long-term use of strong acid suppressive therapy. Patients were evaluated by barium esophagogastric study (BES), esophagoscopy, 24-h pH monitoring (pHM), stationary esophageal manometry, gastric-emptying studies (GES), pancreatic polypeptide stimulation test (PPT) and clinical evaluation using questionnaires. Results: Perioperative complications necessitated conversion to laparatomy in two cases, and there was no mortality. Severe dysphagia resulted in reoperation in two patients. The average maximum lower esophageal sphincter pressure (MLESP) increased from 6.1 mmHg to 12.7 mmHg. Endoscopy showed improved grading of the esophagitis, and the total percentage of pH less than 4 during 24 h decreased from a mean of 9.2 to 0.95. Three patients demonstrated impaired PPTs postoperatively; two had (mild) diarrhea. The overall success rate after the operation was 90%. Conclusions: The results of LNF in a limited number of patients with severe and/or resistant gastroesophageal reflux disease (GERD) receiving continuous medical treatment with proton pump inhibitors (PPIs) on a maintenance base are comparable with LNF results in centers with a more liberal policy concerning indications for LNF surgery. Received: 15 September 1997/Accepted: 12 October 1997     

腹腔镜Nissen胃底折叠术治疗胃食管返流病的长期效果

目的:评价腹腔镜Nissen胃底折叠术(laparoscopic Nissen fundoplication,LNF)治疗胃食管返流病的长期效果。方法:从MEDLINE、EMBASE、中国生物医学数据库(CBM)及Cochrane试验注册中心检索纳入了1991年到2007年10月发表的LNF治疗返流性食管炎的随机对照实验,并对纳入研究的方法学质量(随机方法、分配隐藏、盲法)进行评价,最后用Rev-Man4.2.9软件进行分析。结果:纳入4个随机对照实验(RCT),包括440例患者,纳入随访研究共387例。术后主观结果如满意度[OR0.5095%CI(0.25,1.00)]、术后抑酸药物的使用[OR0.4595%CI(0.08,2.53)]、返酸和烧心症状差异无统计学意义,吞咽困难LNF发生率高于传统胃底折叠术(conventional Nissen fundoplicationm,CNF)[OR4.1695%CI(1.51,11.50)]。客观结果如再手术率[OR1.7795%CI0.78,4.72)]、食管测压和24h pH检测两组间差异无统计学意义。结论:本研究中LNF治疗胃食管返流病的长期效果和传统胃底折叠术差异无统计学意义,但LNF术后吞咽困难发生率可能较高。     

Comparison of objective outcomes following laparoscopic Nissen fundoplication versus laparoscopic gastric bypass in the morbidly obese with heartburn

Background: Heartburn and gastroesophageal reflux disease (GERD) affects approximately 25–50% of morbidly obese patients. Although objective physiologic testing has been reported extensively in patients following Nissen fundoplication, there are no previous reports of such testing in morbidly obese patients. A life-saving surgical alternative for the morbidly obese patient is gastric bypass surgery, which usually improves heartburn symptoms in addition to many serious health conditions such as diabetes, hypertension, and sleep apnea. We hypothesized that, in morbidly obese patients, gastric bypass surgery would be as effective as Nissen fundoplication in reducing both heartburn symptoms and esophageal acid exposure, as reflected by the DeMeester score. Methods: Between 1995 and 2000, all patients undergoing laparoscopic Nissen fundoplication (LN) and laparoscopic gastric bypass (LGB) in our practice underwent preoperative and postoperative esophageal physiologic testing. Patients were included in this study that were morbidly obese and had significant heartburn symptoms or objective evidence of acid reflux, and had repeat esophageal physiologic testing after either LN or LGB. Data were obtained through retrospective review of prospectively collected data. Results: Twelve patients met the inclusion criteria: six patients who had LN and six who had LGB. The mean body mass index (BMI) was 55 kg/m² in the LGB group and 39.8 in the LN group. After surgery, the mean DeMeester score decreased from 64.3 to 2.8 in the LN group (p = 0.01) and from 34.7 to 5.7 in the LGB group (p = 0.1). Both groups mean postoperative DeMeester scores were normal after surgery, and there was no significant difference between the two groups (p = 0.3). Both groups experienced a significant improvement in heartburn symptoms postoperatively. The mean preoperative symptom score improved from 3.5 to 0.5 in the LN group (p = 0.01) and from 2.2 to 0.2 in the LGB group (p = 0.003). There was no difference in the mean postoperative symptom scores between the groups (p = 0.35). After surgery, mean LES resting pressures increased from 12.9 to 35.5 (p = 0.003) in the LN group and from 23.6 to 29.7 (p = 0.45) in the LGB group. There were no complications in either group. Conclusion: Results of this study show that laparoscopic gastric bypass and laparoscopic Nissen fundoplication are both effective in treating heartburn symptoms and objective acid reflux in morbidly obese patients. The health benefits of weight loss after laparoscopic gastric bypass should make this operation the procedure of choice in the morbidly obese patient with heartburn.     

A contemporaneous comparison of hospital charges for laparoscopic and open Nissen fundoplication

Surgical treatment of gastroesophageal reflux disease is increasingly recognized as a costeffective alternative to long-term medical therapy. This fact, coupled with the advent of laparoscopic fundoplication as a safe and efficacious alternative to open surgery, underscores the importance of determining the costs associated with laparoscopic treatment.Hospital costs and charges of patients undergoing open (N=9) and laparoscopic (N=11) fundoplication were retrospectively analyzed. Both procedures were performed during the same time period (6/91–6/93), at the same hospital, and by the same surgical team. Operative time, and hospital stay, were recorded in addition to total, operating room, anesthesia, sterile supplies, and hospital room charges. Figures are reported as mean values ± standard error of the mean. The Wilcoxon signed rank test was used for comparison of groups.Operative time (221±18 vs 165±12 min, P=0.033) was longer in the laparoscopic group, while hospital stay (5.8±02 vs 8.8±04 days, P<0.001) was significantly shorter. Total hospital costs were similar for both groups of patients ($14,615±863 vs $15,891±921, P=0.247). Overall hospital charges were nearly identical ($26,634±1376 vs $27,189±1753, P=0.803). A detailed analysis demonstrated cost shifting, with laparoscopic fundoplication resulting in significantly higher charges associated with events in the operating room. Operating room ($6,064±252 vs $4,283±380, P=0.001), sterile supplies ($6,214±508 vs $5,403±390), and anesthesia charges ($1,593±76 vs $1,122±95, P<0.001) were all greater in the laparoscopic group. This was offset by significantly lower hospital-room charges following laparoscopy ($5,098±355 vs $6,983±511, P=0.006).Laparoscopic Nissen fundoplication is not more expensive than its open counterpart. At present, laparoscopy results in higher operating-room charges which offsets savings from a shorter hospital stay. Improvements in technique and attention to limiting the cost of sterile supplies may ultimately result in a cost savings in favor of laparoscopy.Presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), Nashville, Tennessee, USA, 18–19 April 1994     

A randomized, prospective comparison of the Nissen fundoplication versus the Toupet fundoplication for gastroesophageal reflux disease.

OBJECTIVE: A prospective, randomized trial was performed to determine which of two antireflux procedures, a complete wrap (Nissen) or a 200N wrap (Toupet), was more effective with fewer sequelae. SUMMARY BACKGROUND DATA: Laparoscopic procedures for gastroesophageal reflux disease appear to be as effective as those done by open laparotomy. The Nissen fundoplication is used most frequently, but postoperative bloating, inability to belch, and dysphagia occur. The partial wrap has been said to be as effective with less unfavorable postoperative symptoms. METHODS: Patients with reflux esophagitis were approached laparoscopically using a six-port technique. After division of the short gastric vessels and dissection of the terminal esophagus and fundus of the stomach to allow performance of either procedure, patients randomly were assigned one of the procedures by a card drawn in the operating room. RESULTS: Forty patients underwent operation, but 1 was excluded when an open procedure became necessary. Twenty-three patients received a complete wrap and 16 received a partial wrap. The average operating time was 155 minutes for the Nissen procedures and 162 minutes for the Toupet procedures. The postoperative stay averaged 2.7 days for the Nissen procedures and 2.5 days for the Toupet procedures. There were no deaths. Including the patient converted to an open procedure, three patients had operative complications. At follow-up, Visick scores after the complete wraps were I-13, II-8, III-2 and after the partial wrap were I-12 and II-3. Two patients indicated they would not have the operation again. CONCLUSIONS: A partial or a complete wrap after division of the short gastric vessel offers effective therapy for reflux esophagitis with > 90% patient satisfaction. The authors' study shows no clear advantage of one wrap (partial or complete) over the other.     

Meta-analysis of robot-assisted versus conventional laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease

Background: Conventional laparoscopic Nissen fundoplication (CLF) is generally considered the surgical approach of choice for gastro‐oesophageal reflux disease. Robotic‐assisted laparoscopic fundoplication (RALF) has recently been introduced into laparoscopic clinical practice with the aim of improving surgical performance by eliminating tremors and fatigue. A meta‐analysis of randomized clinical trials (RCTs) was performed to compare RALF and CLF. Methods: Medline, Embase, ISI Web of Knowledge CPCI‐S and The Cochrane Library were searched and the methodological quality of included trials was evaluated. Outcomes evaluated were intraoperative, dysphagia, flatulence, antisecretory medication, satisfaction with intervention, operation time, hospital stay and total cost. Results were pooled in meta‐analyses as risk ratios and weighted mean differences (WMD). Results: Of 221 patients in six RCTs, 111 were allocated to CLF and 110 to RALF. RALF prolonged total time necessary to carry out fundoplication (WMD 3.17 (95% confidence interval. 2.33–4.00) min; P < 0.00001, χ²P = 0.25, I² = 24%). Operation complication, antisecretory medication, satisfaction with intervention, the time needed for hiatal dissection, the time from incision to completion of sutures, the total operation time and total cost were similar in both groups. Conclusion: Clinical outcomes from RALF were comparable to CLF approach, but RALF prolonged the operation time. Currently, CLF should be routinely used as costs are lower.     

Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort

Surgical Endoscopy - Patients with uncontrollable gastroesophageal reflux disease (GERD) often undergo laparoscopic Nissen fundoplication (LNF); however, long-term there are often recurring...     

Randomized clinical trial of standard laparoscopic versus robot-assisted laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease

BACKGROUND: Robotic systems for minimally invasive surgery may be of added value during extensive dissection and suturing in confined spaces, such as laparoscopic Nissen fundoplication (LNF). The purpose of this trial was to compare standard LNF with robot-assisted Nissen fundoplication (RNF). METHODS: Between 2003 and 2005, 50 patients with confirmed refractory gastro-oesophageal reflux disease were assigned to LNF (25) or RNF (25). Patients who had undergone previous antireflux surgery were excluded. Independent assessment of dysphagia, regurgitation, heartburn and general well-being was performed before and 6 months after surgery using questionnaires. Objective outcome was studied 6 months after surgery by oesophageal manometry, 24-h pH monitoring, barium oesophagram series and upper endoscopy. RESULTS: Operating time, blood loss, postoperative pain scores, hospital stay and complication rates did not differ significantly between the two groups. Reoperation rates were the same (one incisional hernia after LNF and one patient with repeat Nissen after RNF because of persistent dysphagia). Postoperative self-rated change in reflux symptoms and quality of life improved equally in both groups. The reduction in oesophageal acid exposure, increase in lower oesophageal sphincter tone and mucosal healing were comparable in both groups at follow-up. CONCLUSION: RNF yielded similar subjective and objective results to LNF in this study. Therefore no additive value of robotic systems for this procedure was detected up to 6 months after surgery.     

A comparison of laparoscopic Nissen fundoplication and Rossetti's modification in 239 patients

Background: Laparoscopic Nissen fundoplication and the Rossetti modification represent two different surgical approaches to resolving gastroesophageal reflux disease (GERD). Concerns have arisen that the Rossetti modification results in increased postoperative dysphagia. In this study, we compared a group of patients who underwent a laparoscopic Nissen fundoplication with a group who had undergone the Rossetti modification to determine if there was a significant difference in postoperative dysphagia. Additionally, we wanted to confirm that the Nissen procedure performed laparoscopically could resolve GERD as successfully as the Rossetti modification, with no difference in operative complications. Methods: We prospectively collected data on 101 patients who underwent laparoscopic Nissen fundoplication and compared outcomes with those of 138 patients who had undergone the laparoscopic Rossetti modification in a previous series. Results: All patients experienced resolution of reflux symptoms. No statistically significant differences were found between the groups in terms of intraoperative or postoperative complications, conversions to open procedure, or length of hospitalization. Paradoxically, there was a significant difference in operating time between the Rossetti and the Nissen groups (70.6 min vs 45.6 min, p= 0.006). Postoperative dysphagia requiring dilation was significantly higher in the Rossetti group (21.7% vs 8.9%, p= 0.008). However, there was a significantly higher percentage of patients in the Rossetti group who had had esophagitis preoperatively (95.7% vs 86.1%, p= 0.009), although the proportion of patients having Barrett's esophagus was higher in the Nissen group (9.4% vs 24.8%, p= 0.001). Conclusions: Both approaches resolved reflux symptoms without significant differences in complications, conversions, or length of stay. Preoperative differences between groups, as well as the method of sequentially comparing the two different procedures, prevent us from attributing greater postoperative dysphagia in the Rossetti group solely to the choice of surgical approach. Prospective randomized studies are needed to control for variables, such as surgical team experience and patient differences. Online publication: 17 April 2000     

Laparoscopic Toupet versus Nissen fundoplication for the treatment of gastroesophageal reflux disease

The Nissen fundoplication is the most popular laparoscopic operation performed for the surgical treatment of gastroesophageal reflux disease (GERD). However, for patients in whom esophageal peristalsis is documented to be weak preoperatively, use of a partial wrap, or Toupet procedure, has often been used as an alternative to lessen the potential for postoperative dysphagia. Recent reports have criticized the Toupet procedure as having a higher long-term failure rate than the Nissen approach, especially for patients with severe forms of GERD. We reviewed our experience performing laparoscopic antireflux surgery over a 7-year period and compared the results of patients undergoing laparoscopic Nissen versus Toupet procedures. All procedures were performed at our institution by a single surgeon. Data recorded included preoperative demographic data, preoperative disease parameters, perioperative data, postoperative course, and symptom scores. Follow-up was based on a combination of medical records and phone interviews. There were 142 patients with complete records allowing review for this study. Of these, 118 underwent 122 Nissen fundoplications and 26 underwent 27 Toupet fundoplications. Selection of the procedure was based on preoperative manometric studies. There were seven reoperations. Seven of the patients (28%) who underwent Toupet procedures had severe GERD, a percentage comparable to the Nissen group (31.6%). Preoperative parameters were comparable for both groups, although the Toupet patients had lower average preoperative LES pressures (9.79 mmHg) than did the Nissen patients (16.1 mmHg, P < 0.05). The operative duration, operative blood loss, morbidity, length of hospitalization, need for reoperation, and efficacy in terms of relieving symptoms (average follow-up = 27.5 months) were comparable for both groups. Based on this experience, the Toupet procedure seems safe and effective in treating the symptoms of GERD, including patients with severe forms of the disease. We recommend its selective use in patients with preoperative esophageal hypomotility who are undergoing laparoscopic antireflux surgery.