Ten-year outcome of laparoscopic and conventional nissen fundoplication: randomized clinical trial.

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Oesophageal acid hypersensitivity is not a contraindication to Nissen fundoplication.

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Impact of surgeon experience on 5-year outcome of laparoscopic Nissen fundoplication

Item does not contain fulltextOBJECTIVE: 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. DESIGN: Multicenter RCT and prospective cohort study. SETTING: University medical centers and tertiary teaching hospitals. PATIENTS: 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. INTERVENTIONS: Conventional Nissen fundoplication, LNFI, and LNFII. MAIN OUTCOME MEASURES: Intraoperative and in-hospital characteristics, objective reflux control, and clinical outcome. RESULTS: 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. CONCLUSIONS: 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

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

Background: 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. Methods: 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. Results: Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was E9126 for LNF and E6989 for CNF at 1 year in the initial RCT, and E7782 in the second LNF series. The success rate of both LNF and CNF at I 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 E998 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. Conclusion: 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

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 LIST (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