Prospective Randomized Study Between Laparoscopic and Open Total Fundoplication in Uncomplicated Gastroesophageal Reflux Disease.
Abstracts
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This study started in 1994 after we had performed over 50 laparoscopic 360° fundoplications.We use complete mobilization of the fundus and posterior crural repair. A short floppy total fundoplication is constructed using three non-absorbable sutures, two of them including the esophageal wall. Our initial experience in the first 50 consecutive patients showed 90% good reflux control. Methods:We included adult patients with uncomplicated reflux disease during the years 1994-1998. Patients with long segment Barretts esophagus, strictures, unhealed severe esophagitis or paraesophageal hernia were not included. We also excluded patients with previous operation on the esophagus or stomach, those with weak peristalsis and suspected short esophagus. The 45 laparoscopic operations were performed by two senior surgeons well trained in laparoscopic antireflux surgery. Forty-eight patients underwent open surgery and these operations were performed or supervised by two other senior surgeons well trained in gastroesophageal surgery. One of the latter recruited all patients. Before operation and half a year postoperatively manometry and 24-h esophageal pH monitoring were performed. Manometry also included short-term reflux test, acid clearing test and acid perfusion test. Symptom evaluation (modified DeMeester score) was performed before operation, half a year after and at long-term follow-up in 2001. Long-term follow-up also included endoscopy. Results:Half a year after laparoscopy 39/45 (87%) were satisfied and had good reflux control. Four patients had disabling dysphagia (one reoperated) and two had postoperative paraesophageal hernia (2 reoperated). Corresponding figures after open operation were 47/48 (98%). One patient was reoperated due to "herniated Nissen". Three patients with good reflux control after operation had died in intercurrent disease at late follow-up. Sixty-two per cent (28/45) of the patients operated with laparoscopy were satisfied compared to 91 per cent (41/45) after open operation. The difference was significant (p<0.01). After laparoscopy seven were reoperated, three planned for reoperation, four had recurrent disease and three had disabling dysphagia. In the open group three patients were reoperated and one patient with recurrent disease was waiting for reoperation. Conclusion: Postoperative disabling dysphagia remains at long-term follow-up. Surgical technique in laparoscopic fundoplication needs improvement. |
