Articles: surgery.
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Objective. The authors attempted to design and conduct a randomized, prospective study to investigate the efficacy of spinal cord stimulation (SCS) for patients with chronic back and leg pain following at least one previous surgery. While the scientific advantages of the randomized, prospective trial are considerable, the authors encountered numerous practical and ethical difficulties with conducting these trials. ⋯ Conclusions. By utilizing a randomized interventional study design, problems of comparability of procedures, provider reluctance to participate in randomized clinical trials, provider bias, detection bias, and transfer bias are eliminated. It is suggested that future investigations, particularly those which are interventionally or device-based, conform to this particular model.
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One hundred and thirty-two patients with reflux symptoms underwent a primary Lind fundoplication between April 1986 and February 1994; all operations were supervised or performed by one surgeon. The median age at operation was 47 (range 17-77) years. All patients attended for follow-up in the early postoperative period. It was possible to conduct a telephone interview to assess long-term symptom control, at a median time of 9.5 (range 5-13) years following operation, in 112 of the 124 patients who were still alive. ⋯ Open Lind fundoplication appears to be effective in the long-term control of gastro-oesophageal reflux in 95 per cent of patients and represents a standard against which the long-term results of laparoscopic surgery will need to be compared.