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Herniation of a portion of the stomach through the esophageal hiatus into the posterior mediastinum is a common affliction of humans. The incidence of hiatal hernia is difficult to determine because of the absence of symptoms in a large number of patients. Upper gastrointestinal barium examinations in symptomatic patients identify some type of hiatal hernia in as many as 15% of patients.

The decision for, and choice of, a remedial antireflux procedure after a failed fundoplication is a challenging clinical problem. Success depends upon many factors including the primary symptom responsible for failure, the severity of underlying anatomic and physiologic defects, and the number and type of previous remedial attempts. Satisfactory outcomes after reoperative fundoplication have been reported to be as low as 50%. Consequently, the ideal treatment option is not clear. The purpose of this study was to evaluate the outcome of gastrectomy as a remedial antireflux procedure for patients with a failed fundoplication. The study population consisted of 37 patients who underwent either gastrectomy (n = 12) with Roux-en-Y reconstruction or refundoplication (n = 25) between 1997-2005. Average age, M/F ratio, and preoperative BMI were not significantly different between the two groups. Outcome measures included perioperative morbidity, relief of primary and secondary symptoms, and the patients' overall assessment of outcome. Mean follow up was 3.5 and 3.3 years in the gastrectomy and refundoplication groups, respectively (p = 0.43). Gastrectomy patients had a higher prevalence of endoscopic complications of GERD (58% vs 4%, p = 0.006) and of multiple prior fundoplications than those having refundoplication (75% vs 24%, p = 0.004). Mean symptom severity scores were improved significantly by both gastrectomy and refundoplication, but were not significantly different from each other. Complete relief of the primary symptom was significantly greater after gastrectomy (89% vs 50%, p = 0.044). Overall patient satisfaction was similar in both groups (p = 0.22). In-hospital morbidity was higher after gastrectomy than after refundoplication (67% vs 20%, p = 0.007) and new onset dumping developed in two gastrectomy patients. In select patients with severe gastroesophageal reflux disease (GERD) and multiple previous fundoplications, primary symptom resolution occurs significantly more often after gastrectomy than after repeat fundoplication. Gastrectomy, however, is associated with higher morbidity. Gastrectomy is an acceptable treatment option for recurrent symptoms particularly when another attempt at fundoplication is ill advised, such as in the setting of multiple prior fundoplications or failed Collis gastroplasty.

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Ethical considerations relevant to the implementation of new surgical technologies and techniques are explored and discussed in practical terms in this statement, including (1) How is the safety of a new technology or technique ensured?; (2) What are the timing and process by which a new technology or technique is implemented at a hospital?; (3) How are patients informed before undergoing a new technology or technique?; (4) How are surgeons trained and credentialed in a new technology or technique?; (5) How are the outcomes of a new technology or technique tracked and evaluated?; and (6) How are the responsibilities to individual patients and society at large balanced? The following discussion is presented with the intent to encourage thought and dialogue about ethical considerations relevant to the implementation of new technologies and new techniques in surgery.

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