OBJECTIVE: A recent randomized study has shown that the long-term effects of continuous medical treatment of gastroesophageal reflux disease (GERD) with a proton-pump inhibitor are comparable to those of open fundoplication. We compared the long-term effects of anti-reflux surgery with those of medical care according to clinical practice. MATERIAL AND METHODS: This is a questionnaire-based 3-10 years follow-up study of 373 patients with GERD operated on in two hospitals with eitheropen or laparoscopic fundoplication, and pair-matched non-operated controls treated medically according to clinical practice. The controls were matched for hospital, age, sex, follow-up time, degree of esophagitis, presence of hiatus hernia and Barrett's esophagus. The questionnaires used for symptoms and health-related quality of life (QoL) were the Gastrointestinal Symptoms Rating Scale and the Psychological General Well-Being Index, respectively. RESULTS:Response rates were about 80%, and 179 pairs of operated patients and controls remained for analysis (102 based on laparoscopic and 77 on open fundoplication). Independently of the surgical technique, the operated patients suffered at the follow-up from significantly (p <0.001) fewer reflux symptoms than the non-operated controls, the mean scores being 1.34 and 2.51, respectively. The operated patients suffered from slightly more symptoms of indigestion (p <0.05). No consistent significant differences between the groups were found for QoL. Significant differences in QoL in favor of the operated patients were found when dealing only with the 43 pairs with no concurrent disease. CONCLUSION: The study shows that in our area anti-reflux surgery is more effective in relieving reflux symptoms than medical care according to clinical practice.
RCT Entities:
OBJECTIVE: A recent randomized study has shown that the long-term effects of continuous medical treatment of gastroesophageal reflux disease (GERD) with a proton-pump inhibitor are comparable to those of open fundoplication. We compared the long-term effects of anti-reflux surgery with those of medical care according to clinical practice. MATERIAL AND METHODS: This is a questionnaire-based 3-10 years follow-up study of 373 patients with GERD operated on in two hospitals with either open or laparoscopic fundoplication, and pair-matched non-operated controls treated medically according to clinical practice. The controls were matched for hospital, age, sex, follow-up time, degree of esophagitis, presence of hiatus hernia and Barrett's esophagus. The questionnaires used for symptoms and health-related quality of life (QoL) were the Gastrointestinal Symptoms Rating Scale and the Psychological General Well-Being Index, respectively. RESULTS: Response rates were about 80%, and 179 pairs of operated patients and controls remained for analysis (102 based on laparoscopic and 77 on open fundoplication). Independently of the surgical technique, the operated patients suffered at the follow-up from significantly (p <0.001) fewer reflux symptoms than the non-operated controls, the mean scores being 1.34 and 2.51, respectively. The operated patients suffered from slightly more symptoms of indigestion (p <0.05). No consistent significant differences between the groups were found for QoL. Significant differences in QoL in favor of the operated patients were found when dealing only with the 43 pairs with no concurrent disease. CONCLUSION: The study shows that in our area anti-reflux surgery is more effective in relieving reflux symptoms than medical care according to clinical practice.
Authors: Oscar Vidal; Antonio Maria Lacy; Manuel Pera; Mauro Valentini; Jesus Bollo; Gloria Lacima; Luis Grande Journal: J Gastrointest Surg Date: 2006-06 Impact factor: 3.452
Authors: Per G Farup; Ivar Blix; Sigurd Førre; Gjermund Johnsen; Ove Lange; Rune Johannessen; Hermod Petersen Journal: BMC Health Serv Res Date: 2011-05-20 Impact factor: 2.655