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Abstract
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.