Surgical endoscopy · 2015
One- and ten-year outcome of laparoscopic anterior 120° versus total fundoplication: a double-blind, randomized multicenter study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Djerf Pauline, Montgomery Agneta, Hallerbäck Bengt, Håkansson Hans-Olof, Johnsson Folke
Аннотация
BACKGROUND: Nissen fundoplication is an effective treatment for gastroesophageal reflux disease (GERD) but can cause adverse effects like flatulence and dysphagia. The aim was to compare laparoscopic anterior 120° fundoplication (APF) to total fundoplication (Nissen) concerning flatulence and other adverse effects, in a randomized blinded study.
METHODS: Seventy-two patients were randomized to APF (n = 36) or Nissen (n = 36). Gastroscopy, 24-h pH monitoring and evaluation for symptoms and quality of life using questionnaires (GSRS, PGWB and 7-graded Likert scales) were performed preoperatively, at 1 and 10 years postoperatively. Patients and the researchers were blinded to operative method.
RESULTS: When entering the study, most patients had mild-moderate reflux disease according to the symptom score, the 24-h pH measurements, and frequency and grade of esophagitis. At 1-year (n = 68) flatulence, dysphagia, heartburn and acid regurgitation did not differ between groups. More patients could belch (p = 0.005), and pH monitoring showed a higher time with pH < 4 in the APF group (p = 0.006). At 10 years (n = 61), the APF group reported less dysphagia (p < 0.001), more heartburn (p = 0.019) and more patients could belch (p = 0.012) and vomit (p < 0.001) compared to the Nissen. No difference remained at 10 years in pH monitoring (n = 23) between groups. Symptoms of heartburn and acid regurgitation were less than preoperatively in both groups (p < 0.001). No revisional operations were performed.
CONCLUSIONS: Both procedures offer good long-term control of reflux symptom, with modest post-fundoplication symptoms. Anterior 120° fundoplication results in less dysphagia, better ability to belch and vomit than total fundoplication at 10-year follow-up. The results suggest that APF could be an alternative to Nissen fundoplication in the surgical treatment of mild-moderate GERD.
METHODS: Seventy-two patients were randomized to APF (n = 36) or Nissen (n = 36). Gastroscopy, 24-h pH monitoring and evaluation for symptoms and quality of life using questionnaires (GSRS, PGWB and 7-graded Likert scales) were performed preoperatively, at 1 and 10 years postoperatively. Patients and the researchers were blinded to operative method.
RESULTS: When entering the study, most patients had mild-moderate reflux disease according to the symptom score, the 24-h pH measurements, and frequency and grade of esophagitis. At 1-year (n = 68) flatulence, dysphagia, heartburn and acid regurgitation did not differ between groups. More patients could belch (p = 0.005), and pH monitoring showed a higher time with pH < 4 in the APF group (p = 0.006). At 10 years (n = 61), the APF group reported less dysphagia (p < 0.001), more heartburn (p = 0.019) and more patients could belch (p = 0.012) and vomit (p < 0.001) compared to the Nissen. No difference remained at 10 years in pH monitoring (n = 23) between groups. Symptoms of heartburn and acid regurgitation were less than preoperatively in both groups (p < 0.001). No revisional operations were performed.
CONCLUSIONS: Both procedures offer good long-term control of reflux symptom, with modest post-fundoplication symptoms. Anterior 120° fundoplication results in less dysphagia, better ability to belch and vomit than total fundoplication at 10-year follow-up. The results suggest that APF could be an alternative to Nissen fundoplication in the surgical treatment of mild-moderate GERD.