Laparoscopic or conventional Nissen fundoplication for gastrooesophageal reflux disease: randomised clinical trial

Bais, J. E.; Bartelsman, J F W M; Bonjer, H. J.; C, Ma; Go, P.M.M.Y.H.; Klinkenberg‐Knol, E. C.; Lanschot, Jjb van; Nadorp, J. H. S. M.; Smout, A. J. P. M.; Graaf, Y. van der; Gooszen, H. G.

doi:10.1016/s0140-6736(99)03097-4

Cited by 259 publications

(152 citation statements)

References 24 publications

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“…76 -79 A short-term analysis of postoperative results at the scheduled follow-up (range 3 to 24 months) failed to show any differences concerning recurrence, dysphagia, bloating, and reoperation for failure, suggesting that, while waiting for longer follow-up, the laparoscopic approach reproduces the same results as its open counterpart. However, the only multicenter RCT 35 had to be stopped at its interim analysis due to an unacceptable rate of postoperative dysphagia in the laparoscopic arm (Table 3). The publication of this trial triggered many critiques, 80 mainly related to the low volume of cases treated per surgeon per year (about 2.7), and its authors had to admit that their results were biased by the existence of a learning curve and a maintenance curve.…”

Section: Open Versus Laparoscopic Fundoplicationmentioning

confidence: 99%

Evidence-Based Appraisal of Antireflux Fundoplication

Catarci

Gentileschi²,

Papi³

et al. 2004

Annals of Surgery

277

178

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Objective: To highlight the current available evidence in antireflux surgery through a systematic review of randomized controlled trials (RCTs). Summary Background Data: Laparoscopic fundoplication is currently suggested as the gold standard for the surgical treatment of gastroesophageal reflux disease, but many controversies are still open concerning the influence of some technical details on its results. Methods: Papers related to RCTs identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. Defined outcomes were examined for 41 papers published from 1974 to 2002 related to 25 RCTs. A meta-analysis was performed pooling the results as odds ratios (OR), rate differences (RD), and number needed to treat (NNT). Data given as mean and/or median values were pooled as a mean Ϯ SD (SD). Results: No perioperative deaths were found in any of the RCTs. Immediate results showed a significantly lower operative morbidity rate (10.3% versus 26.7%, OR 0.33, RD Ϫ12%, NNT 8), shorter postoperative stay (3.1 versus 5.2 days, P ϭ 0.03), and shorter sick leave (20.1 versus 35.8 days, P ϭ 0.03) for laparoscopic versus open fundoplication. No significant differences were found regarding the incidence of recurrence, dysphagia, bloating, and reoperation for failure at midterm follow-up. No significant differences in operative morbidity (13.1% versus 9.4%) and in operative time (90.2 versus 84.2 minutes) were found in partial versus total fundoplication. A significantly lower incidence of reoperation for failure (1.6% versus 9.6%, OR 0.21, RD Ϫ7%, NNT 14) was found after partial fundoplication, with no significant differences regarding the incidence of recurrence and/or dysphagia. Routine division of short gastric vessels during total fundoplication showed no significant advantages regarding the incidence of postoperative dysphagia and recurrence when compared with no division. The use of ultrasonic scalpel compared with clips or bipolar cautery for the division of short gastric vessels showed no significant effect on operative time, postoperative complications, and costs. Conclusions: Laparoscopic antireflux surgery is at least as safe and as effective as its open counterpart, with reduced morbidity, shortened postoperative stay, and sick leave. Partial fundoplication significantly reduces the risk of reoperations for failure over total fundoplication. Routine versus no division of short gastric vessels showed no significant advantages. A word of caution is needed when implementing these results derived from RCTs performed in specialized centers into everyday clinical practice, where experience and skills may be suboptimal.

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Section: Open Versus Laparoscopic Fundoplicationmentioning

confidence: 99%

Evidence-Based Appraisal of Antireflux Fundoplication

Catarci

Gentileschi²,

Papi³

et al. 2004

Annals of Surgery

277

178

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“…One year after surgery, all patients in the laparoscopic group and 86% of patients in the open group were satisfied with the operation. The fourth RCT by Bais et al [5] also compared laparoscopic and open Nissen fundoplication (1b). They analyzed data on 103 patients from an ad hoc questionnaire.…”

Section: Long-term Improvement Of Qol Is Not Different When Compared mentioning

confidence: 99%

Evaluation of quality of life after laparoscopic surgery: evidence-based guidelines of the European Association for Endoscopic Surgery

et al. 2004

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Background: Measuring health-related quality of life (QoL) after surgery is essential for decision making by patients, surgeons, and payers. The aim of this consensus conference was twofold. First, it was to determine for which diseases endoscopic surgery results in better postoperative QoL than open surgery. Second, it was to recommend QoL instruments for clinical research. Methods: An expert panel selected 12 conditions in which QoL and endoscopic surgery are important. For each condition, studies comparing endoscopic and open surgery in terms of QoL were identified. The expert panel reached consensus on the relative benefits of endoscopic surgery and recommended generic and disease-specific QoL instruments for use in clinical research. Results: Randomized trials indicate that QoL improves earlier after endoscopic than open surgery for gastroesophageal reflux disease (GERD), cholecystolithiasis, colorectal cancer, inguinal hernia, obesity (gastric bypass), and uterine disorders that require hysterectomy. For spleen, prostate, malignant kidney, benign colorectal, and benign non-GERD esophageal diseases, evidence from nonrandomized trials supports the use of laparoscopic surgery. However, many studies failed to collect long-term results, used nonvalidated questionnaires, or measured QoL components only incompletely.

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“…In 2000, the results of a prematurely terminated randomized clinical trial (RCT) of LNF versus CNF were published 16 . It was decided to follow this population after the trial had ended and conduct a consecutive cohort study of at least 100 patients with GORD who were refractory to proton-pump inhibitor treatment.…”

Section: Introductionmentioning

confidence: 99%

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

Draaisma

Buskens

Bais

et al. 2006

British Journal of Surgery

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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 ¤9126 for LNF and ¤6989 for CNF at 1 year in the initial RCT, and ¤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 ¤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. 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.

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Laparoscopic or conventional Nissen fundoplication for gastrooesophageal reflux disease: randomised clinical trial

Cited by 259 publications

References 24 publications

Evidence-Based Appraisal of Antireflux Fundoplication

Evidence-Based Appraisal of Antireflux Fundoplication

Evaluation of quality of life after laparoscopic surgery: evidence-based guidelines of the European Association for Endoscopic Surgery

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

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