Conventional Nissen Fundoplication Research Articles

Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and Conventional Nissen Fundoplication: A Plea for Patient Counseling and Clarification.

To analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD). LNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling. Between 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported. A total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047). The effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.

Is there a Future for Robot-assisted Laparoscopic Nissen Fundoplication (RALF)...?

Introduction: Gastroesophageal reflux disease (GERD) has been the main health concern in the last few years, both in term of quality of life and symptomatology and also causing longterm health concern like cancer. In our current practice laparoscopic Nissen fundoplication is the most commonly performed operative procedure for reflux disease. Aim and methodology: We performed our review to predict the future of robot-assisted laparoscopic fundoplication (RALF) by looking at this new technology from different angles namely, comparison with conventional laparoscopic Nissen fundoplication (CLF), in term of operative complications and postoperative outcome, training aspect of RALF, application in complicated cases and difficult tasks, and also in pediatric population. Conclusion: We are in the opinion that there is a promising future for RALF, despite the increased cost and longer operation time. It has been found that RALF can function better in smaller spaces and more capable in finer dissection and it has shorter and steeper learning curve. The time and the cost issue is expected to reduce with further development and upgrades of the robotic surgery, and increase in surgeons experience in RALF. Therefore, we think the trend should be more toward RALF as a future of antireflux surgery.

Laparoscopic versus robot-assisted Nissen fundoplication in an infant pig model

Surgical robots are designed to facilitate dissection and suturing, although objective data on their superiority are lacking. This study compares conventional laparoscopic Nissen fundoplication (CLNF) to robot-assisted Nissen fundoplication (RANF) using computer-based workflow analysis in an infant pig model. CLNF and RANF were performed in 12 pigs. Surgical workflow was segmented into phases. Time required to perform specific actions was compared by t test. The quality of knot-tying was evaluated by a skill scoring system. Cardia yield pressure (CYP) was determined to test the efficacy of the fundoplications, and the incidence of complications was compared. There was no difference in average times to complete the various phases, despite faster robotic knot-tying (p = 0.001). Suturing quality was superior in CLNF (p = 0.02). CYP increased similarly in both groups. Workflow-interrupting hemorrhage and pneumothorax occurred more frequently during CLNF (p = 0.040 and 0.044, respectively), while more sutures broke during RANF (p = 0.001). The robot provides no clear temporal advantage compared to conventional laparoscopy for fundoplication, although suturing was faster in RANF. Fewer complications were noted using the robot. RANF and CLNF were equally efficient anti-reflux procedures. For robotic surgery to manifest its full potential, more complex operations may have to be evaluated.

Impact of Surgeon Experience on 5-Year Outcome of Laparoscopic Nissen Fundoplication

To investigate the 5-year effect of surgeon experience with laparoscopic Nissen fundoplication (LNF). In 2000, a randomized controlled trial (RCT) was prematurely terminated because LNF for gastroesophageal reflux disease was associated with a higher risk to develop dysphagia than conventional Nissen fundoplication (CNF). Criticism focused on alleged bias caused by the relative lack of experience with the laparoscopic approach of the participating surgeons. Multicenter RCT and prospective cohort study. University medical centers and tertiary teaching hospitals. In the RCT, 74 patients underwent CNF and 93 patients underwent LNF (LNFI). The complete setup of the cohort study (LNFII) (n=121) mirrored the RCT, except that surgeon experience increased from more than 5 to more than 30 LNFs per surgeon. Conventional Nissen fundoplication, LNFI, and LNFII. Intraoperative and in-hospital characteristics, objective reflux control, and clinical outcome. In LNFII, operating time (110 vs 165 minutes; P<.001), dysphagia (2.5% vs 12.3%; P=.008), dilatations for dysphagia (0.8% vs 7.0%; P=.02), and conversions (3.5% vs 7.7%; P=.19) were reduced compared with LNFI. Moreover, in LNFII, hospitalization (4.2 vs 5.6 days; P=.07 and 4.2 vs 7.6 days; P<.001) and in-hospital complications (5.1% vs 13.5%; P=.046 and 5.1% vs 19.3%; P=.005) were reduced compared with LNFI and CNF, respectively. In LNFII, the 6-month reintervention rate was reduced compared with LNFI (0.8% vs 10.1%; P=.002). Esophagitis and esophageal acid exposure at 3 months and reflux symptoms, proton-pump inhibitor use, and quality of life at 5 years improved similarly. Operating time, complications, hospitalization, early dysphagia, dilatations for dysphagia, and reintervention rate after LNF improve significantly when surgeon experience increases from more than 5 to more than 30 LNFs. In contrast, short-term objective reflux control and 5-year clinical outcome do not improve with experience. In experienced hands, LNF reduces in-hospital complications and hospitalization compared with CNF, with similar 5-year effectiveness and reoperation rate.

Ten-Year Outcome of Laparoscopic and Conventional Nissen Fundoplication

To compare 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF), with focus on effectiveness and reoperation rate. LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease (GERD). Decisions are based on equal short-term effectiveness and reduced morbidity, but confirmation by long-term level 1 evidence is lacking. From 1997 to 1999, 177 proton pump inhibitor (PPI)-refractory GERD patients were randomized to undergo LNF or CNF. The 10 years results of surgery on reflux symptoms, general health, PPI use, and reoperation rates, are described. High-resolution manometry, 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only. A total of 148 patients (79 LNF, 69 CNF) participated in this 10-year follow-up study. GERD symptoms were relieved in 92.4% and 90.7% (NS) after LNF and CNF, respectively. Severity of heartburn and dysphagia were similar, but slightly more patients had relief of regurgitation after LNF (98.7% vs. 91.0%; P = 0.030). The percentage of patients using PPIs slowly increased with time in both groups to 26.6% for LNF and 22.4% for CNF (NS). General health (74.7% vs. 72.7%; NS) and quality of life (visual analogue scale score: 65.3 vs. 61.4; NS) improved similarly in both groups. The percentage of patients who would have opted for surgery again was similar as well (78.5% vs. 72.7%; NS). Twice as many patients underwent reoperation after CNF compared with LNF (12 [15.2%] vs. 24 [34.8%]; P = 0.006), including a higher number of incisional hernia corrections (2 vs. 9; P = 0.015). Mean interval between operation and reintervention was longer after CNF (22.9 vs. 50.6 months; P = 0.047). Of the patients who were dependent on daily PPI therapy at 10 years (LNF 10, CNF 10), 7 patients (LNF 3, CNF 4) had recurrent GERD on pH-impedance monitoring, 5 of them with some form of anatomic recurrence. A total of 13 of 20 (65.0%) patients did not have recurrent GERD. Fourteen patients had an abnormal high-resolution manometry. CNF carries a higher risk for surgical reintervention compared with LNF, mainly due to incisional hernia corrections. The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control. Consequently, the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD.

W1853 Ten-Year Outcome of Laparoscopic and Conventional Nissen Fundoplication: Randomized Clinical Trial

W1853 Ten-Year Outcome of Laparoscopic and Conventional Nissen Fundoplication: Randomized Clinical Trial

Magnetic Augmentation of the Lower Esophageal Sphincter: Results of a Feasibility Clinical Trial

BackgroundThe high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy. MethodsPatients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus. ResultsOver a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12–434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred. ConclusionsLaparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.

The Visick score: A good measure for the overall effect of antireflux surgery?

Objective. In scoring the outcome of antireflux surgery, it is extremely difficult to combine the effect on reflux symptoms and esophageal acid exposure in one and the same single system – the Visick score revisited. The aim of this study was to correlate subjective outcome variables and objective outcome variables in an attempt to come to an overall reproducible scoring system. Material and methods. From 1997 to 1999, a randomized trial was set up to compare 98 patients who had undergone laparoscopic Nissen fundoplication (LNF) with 79 patients treated with conventional Nissen fundoplication (CNF). All patients were requested to complete a questionnaire, before and 3, 6, 12, 24 and 60 months after surgery. A subgroup of 87 patients agreed to undergo objective evaluation by pH-metry. The results of all these assessments were correlated with the effect of surgery on the Visick score. Results. After LNF and CNF, 79 and 69 patients, respectively, completed the questionnaires. After 5 years, complaints about heartburn, regurgitation and dysphagia were still significantly improved in the majority of patients, but in these groups, 6, 3 and 27% of patients, respectively, experienced deterioration. Visick score I or II (complaints resolved or improved) was recorded by 87% of patients. The Visick score correlated with the reduction of postoperative reflux symptom grades for heartburn, but not with the reduction of regurgitation, dysphagia and esophageal acid exposure. Conclusions. Although this study shows that the Visick score can be applied to monitor the subjective effect of primary antireflux surgery as it correlates well with the most prominent symptom of GERD (heartburn), it also underlines the difficulty in adequately scoring symptomatic outcome of antireflux surgery.

Comparison of Long-term Outcome of Laparoscopic and Conventional Nissen Fundoplication

The aim of this study was to compare the long-term objective and subjective outcomes of laparoscopic and open Nissen fundoplication in a randomized clinical trial with an 11-year follow-up. Laparoscopic Nissen fundoplication has become the method of choice in antireflux surgery, replacing its open counterpart despite the lack of long-term results from controlled clinical studies. Between April 1992 and June 1995, 110 consecutive patients were randomized to either laparoscopic (LAP) or conventional (open) Nissen fundoplication. The objective long-term follow-up consisted of an upper gastrointestinal endoscopy and a clinical assessment; the subjective long-term outcome was investigated by personal interviews using a structured questionnaire. Forty-nine patients in the LAP group and 37 patients in the open group were available for evaluation. Late subjective results, including postoperative symptoms and evaluation of the surgical result, were similar in both groups. With the benefit of hindsight, 73.7% of the patients in the open group and 81.8% in the LAP group would again choose surgical treatment (P = 0.3042). In the LAP group, there were 5 (13.2%) partially or totally disrupted plications compared with the 14 (40.0%) disrupted plications in the open group (P = 0.0152). There were 10 incisional hernias in the open group compared with none in the LAP group (P < 0.001). At long-term follow-up, the open and LAP approaches for the Nissen fundoplication have similar long-term subjective symptomatic outcome despite the significantly higher incidence of incisional hernias and defective fundic wraps at endoscopy in the open group defining laparoscopic Nissen fundoplication as the procedure of choice in surgical management of gastroesophageal reflux disease.

Five-Year Subjective and Objective Results of Laparoscopic and Conventional Nissen Fundoplication: A Randomized Trial

Five-Year Subjective and Objective Results of Laparoscopic and Conventional Nissen Fundoplication: A Randomized Trial

Five-Year Subjective and Objective Results of Laparoscopic and Conventional Nissen Fundoplication: A Randomized Trial

Five-Year Subjective and Objective Results of Laparoscopic and Conventional Nissen Fundoplication: A Randomized Trial

Five-Year Subjective and Objective Results of Laparoscopic and Conventional Nissen Fundoplication

The purpose of this prospective study was to compare the subjective and objective outcome of laparoscopic (LNF) and conventional Nissen fundoplication (CNF) up to 5 years after surgery as obtained in a multicenter randomized controlled trial. LNF is regarded as surgical treatment of first choice for refractory gastroesophageal reflux disease by many surgeons based on several short- and mid-term studies. The long-term efficacy of Nissen fundoplication, however, is still questioned as objective data gathered from prospective studies are lacking. From 1997 to 1999, 177 patients were randomized to undergo LNF or CNF. Five years after surgery, all patients were requested to fill in questionnaires and to undergo esophageal manometry and 24-hour pH-metry. A total of 148 patients agreed to participate in the follow-up study: 79 patients after LNF and 69 after CNF. Of these, 97 patients (48 LNF, 49 CNF) consented to undergo esophageal manometry and 24-hour pH-metry. At 5 years follow-up, 20 patients had undergone reoperation: 12 after LNF (15%) and 8 after CNF (12%). There was no difference in subjective outcome, with overall satisfaction rates of 88% and 90%, respectively. Total esophageal acid exposure times (pH < 4) were 2.1% +/- 0.5% and 2.0% +/- 0.6%, respectively (P = 0.21). Antisecretory medication was taken daily in 14% and 16%, respectively (P = 0.29). There was no correlation between medication use and acid exposure and indices of symptom-reflux association (symptom index and symptom association probability). No significant differences between subjective and objective results at 3 to 6 months and results obtained at 5 years after surgery were found. The effects of LNF and CNF on general state of health and objective reflux control are sustained up to 5 years after surgery and the long-term results of LNF and CNF are comparable. A substantial minority of patients in both groups had a second antireflux operation or took antisecretory drugs, although the use of those medications did not appear to be related to abnormal esophageal acid exposure.

Randomized clinical trial and follow-up study of cost-effectiveness of laparoscopic versus conventional Nissen fundoplication

Laparoscopic Nissen fundoplication (LNF) has essentially replaced its conventional open counterpart (CNF). An economic evaluation of LNF compared with CNF based on prospective data with adequate follow-up is lacking. Data from two consecutive studies (a randomized clinical trial (RCT) of 57 patients undergoing LNF and 46 undergoing CNF that was terminated prematurely, and a follow-up study of 121 consecutive patients with LNF) were combined to determine incremental cost-effectiveness 1 year after surgery. Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was euro 9126 for LNF and euro 6989 for CNF at 1 year in the initial RCT, and euro 7782 in the second LNF series. The success rate of both LNF and CNF at 1 year was 91 per cent in the RCT, and LNF was successful in 90.1 per cent in the second series. A cost reduction of euro 998 for LNF would cancel out the cost advantage of CNF. Similarly, if the reoperation rate after LNF decreased from 0.05 to below 0.008 and/or if the mean duration of sick leave after LNF was reduced from 67.2 to less than 61.1 days, the procedure would become less expensive than CNF. Complications, reoperation rate and quality of life after both operations were similar. Including reinterventions, the outcome at 1 year after LNF and CNF was similar. In a well organized setting with appropriate expertise, the cost advantage of CNF may be neutralized.

Five year??s subjective and objective results of antireflux surgery: a randomized controlled trial of laparoscopic versus conventional Nissen fundoplication

Draaisma, WA1; Rijnhart-de Jong, HG1; Broeders, IAMJ1; Smout, AJPM2; Oors, J2; van der Scheur, J2; Furnee, EJB1; Gooszen, HG1 2 Author Information

Long-term outcome is worse after laparoscopic than after conventional Nissen fundoplication

Objective. No long-term studies of laparoscopic and open fundoplication were available in 1994. The aim of this study was to compare reflux control and side effects after laparoscopic and open fundoplication. Material and methods. Adult patients with uncomplicated gastro-oesophageal reflux disease were included in this prospective randomized clinical trial between laparoscopic and open 360° fundoplication. Patients with uncomplicated gastro-oesophageal reflux disease were included with the exception of those with weak peristalsis or suspected short oesophagus. Two senior surgeons, well trained in laparoscopic antireflux surgery, performed the 45 laparoscopic operations. Forty-eight patients underwent open surgery performed or supervised by two other senior surgeons, also well trained in gastro-oesophageal surgery. One of the latter recruited all the patients. Manometry and 24-h oesophageal pH monitoring were performed before operation and 6 months postoperatively. Manometry also included a short-term reflux test, an acid clearing test and an acid perfusion test. Symptom evaluation was performed before surgery, 6 moths after and at long-term follow-up (33–79 months postoperatively) by the same surgeon. Long-term follow-up also included endoscopy. Results. Six months after laparoscopy 4 patients had disabling dysphagia. None of the patient had disabling dysphagia after laparotomy. Four patients had mild heartburn 6 months after laparoscopy and 2 patients after laparotomy. Between 6 months’ follow-up and long-term follow-up, 6 patients were reoperated on in the laparoscopy group and 2 patients in the laparotomy group. Three patients operated on with laparotomy had died of intercurrent diseases. After laparoscopy, at long-term follow-up, 62% of patients (28/45) were satisfied compared with 91% (41/45) after laparotomy. The difference was significant (p<0.01). Conclusions. Early postoperative reflux control was similar for laparoscopic and conventional fundoplication. At long-term follow-up significantly more patients were satisfied after laparotomy than after laparoscopy.

Cost-effectiveness of laparoscopic and conventional Nissen fundoplication in a randomised clinical trial.

Cost-effectiveness of laparoscopic and conventional Nissen fundoplication in a randomised clinical trial.

A prospective randomized study of the systemic immune response after laparoscopic and conventional Nissen fundoplication

Background: Laparoscopic techniques are thought to reduce the postoperative immunologic and metabolic changes of conventional operations. Until now, the only clinical data available were obtained from patients operated on for symptomatic gallstones; moreover, few studies were randomized. This randomized prospective study compares the systemic immune response after laparoscopic and conventional Nissen fundoplication. Methods: Seventeen patients scheduled for Nissen fundoplication were randomly assigned to undergo either a laparoscopic or a conventional procedure. Postoperative inflammatory response was assessed by measuring the white blood cell count, C-reactive protein, and soluble tumor necrosis factor receptors p55 and p75. Postoperative immune function was assessed by measuring monocyte HLA-DR expression and the stress response was assessed by measuring plasma cortisol concentrations. Results: Laparoscopic surgery resulted in significantly lower plasma CRP levels 1 day after surgery. Both approaches resulted in a significant decrease in HLA-DR expression within 2 hours after surgery. After the laparoscopic approach, postoperative expression was restored to preoperative values within 1 day after surgery. However, after conventional surgery HLA-DR expression remained suppressed and did not return to preoperative values until the fourth postoperative day. No significant differences between the 2 procedures were observed in white cell blood count, sTNFr-p55 and p75, nor in postoperative cortisol levels. Conclusions: Although both laparoscopic and conventional Nissen fundoplication result in an activation of the systemic immune response, this study suggests that this response could be less after the laparoscopic approach. The differences found may reflect a lower risk for postoperative infective complications. (Surgery 1999;126:5-9.)

Is There a Place for Laparoscopic Antireflux Surgery in The Netherlands?

Background: Antireflux surgery has not gained wide acceptance in The Netherlands in the past two decades. The introduction of laparoscopic fundoplication seems to have had no impact on the number of antireflux operations performed per year. Methods: The SIG data were consulted in order to compile an inventory on the number of antireflux operations performed in The Netherlands between 1977 and 1995. The data were compared with those kindly supplied by the Laparoscopic Societies of the Scandinavian countries. Results: The number of antireflux operations per year in The Netherlands, 1.7/100,000 per year, is far less than reported in the four Scandinavian countries, 15/100,000 per year, and also far below the 10/100,000 per year needed for antireflux surgery on a yearly basis. Conclusions: In The Netherlands, 1.7/100,000 inhabitants per year undergo antireflux surgery. This figure has remained virtually stable in the past two decades, i.e. it has not changed even since the introduction of H 2 -receptor antagonists, proton-pump inhibitors and laparoscopic antireflux surgery. The success of medical treatment and personal, anecdotal, experience of gastroenterologists with patients they have referred for surgery explain the low number of antireflux operations performed. Currently, a randomized trial is being conducted in The Netherlands comparing the effectivity, costs and quality of life after conventional Nissen fundoplication with the laparoscopic approach. All operations are performed or supervised by a limited number of experienced surgeons who have gone through the learning curve of both the open and conventional technique.

Laparoscopic Nissen fundoplication: Operative results and short-term follow-up

The operative results, outcome, and short-term follow-up after laparoscopic exploration for Nissen fundoplication were evaluated in 35 patients with symptomatic gastroesophageal reflux and reflux-induced pulmonary disease. There were 19 female and 16 male patients, ranging in age from 17 to 72 years (mean: 42 years, SD: 11.6 years). In 20 patients, the symptoms were predominantly of regurgiation and heartburn; the remaining 15 patients had mixed regurgitation/heartburn and pulmonary symptoms. All patients underwent 24-hour pH monitoring, upper endoscopy, and manometry. The indication for surgery was medical failure or the need for long-term medical management with omeprazole. The operation, which was performed laparoscopically, is identical to the conventional Nissen fundoplication. There was a mortality rate of 0% and a morbidity rate of 25.7%. Five patients required conversion to open Nissen fundoplication, which was due to hemodynamic instability secondary to presumed pneumothorax in three patients and colotomy and a distal esophageal perforation in the other two patients. Thirty patients underwent laparoscopic Nissen fundoplication. Three patients developed early dysphagia, and one patient experienced a perforation of the piriform sinus due to nasogastric tube manipulation under anesthesia. All these patients had an uncomplicated postoperative course, and there was no long-term disability. The total surgical time of laparoscopic Nissen fundoplication was on average 107 minutes (SD: 35.3 minutes). Discharge usually occurred on the evening of postoperative day 2 (mean: 3.3 days; SD: 1.5 days). Twenty-six of the 30 patients who underwent laparoscopic Nissen fundoplication described the outcome as excellent and good (87%); however, 4 patients (13%) were unsatisfied. Fifteen patients (50%) had difficulty belching or vomiting, and moderate dysphagia was described by 7 patients (24%) in follow-up. Regurgitation and heartburn were cured in 96%, whereas reflux-induced pulmonary disease was cured in 50%. The results of laparoscopic Nissen fundoplication compare favorably with those of conventional Nissen fundoplication with respect to mortality, complications, and outcome.