Randomized controlled trial of laparoscopic anterior 180° partial versus posterior 270° partial fundoplication.

BACKGROUND: Previous trials show good outcomes following anterior and posterior partial versus Nissen fundoplication for gastro-oesophageal reflux. However, it is unclear which partial fundoplication performs best. This study compared anterior 180° versus posterior 270° fundoplication. METHODS: At three hospitals, patients were randomized to anterior 180° versus posterior 270° partial fundoplication, and clinical outcomes were determined using a structured questionnaire at 3, 6 and 12 months. Heartburn, dysphagia and satisfaction were assessed using 0-10 analoue scales, and adverse outcomes and side effects were determined. Endoscopy, manometry and pH monitoring were performed 6 months after surgery. RESULTS: Forty-seven patients were randomized to anterior (n = 23) versus posterior (n = 24) fundoplication. Clinical outcomes for 93-98% of patients were available at each follow-up point. At 12 months, the mean heartburn score was higher following anterior fundoplication (2.7 versus 0.8, P = 0.045), although differences were not significant at earlier follow-up. Conversely, following posterior fundoplication, patients were less able to belch at 3 (56% versus 16%, P = 0.013) and 6 months (43% versus 9%, P = 0.017). No significant differences were demonstrated for dysphagia. Both groups had high rates of satisfaction with the outcome - 85% versus 86% satisfied at 12 months follow-up. CONCLUSION: Both partial fundoplications are effective treatments for gastro-oesophageal reflux. Posterior partial fundoplication is associated with less reflux symptoms offset by more side effects.

Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication.

HYPOTHESIS: Laparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication. DESIGN: A multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years' follow-up. SETTING: Nine university teaching hospitals in 6 major cities throughout Australia and New Zealand. PARTICIPANTS: One hundred twelve patients undergoing primary antireflux surgery were randomized to undergo either laparoscopic Nissen fundoplication (52 patients) or anterior 90 degrees partial fundoplication (60 patients). INTERVENTIONS: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication. MAIN OUTCOME MEASURES: Blinded assessment at 1 and 5 years' follow-up of clinical outcome for postoperative heartburn, dysphagia, gas-related symptoms, and satisfaction with the surgical outcome. Analog scales ranging from 0 to 10 were used to assess symptom severity. RESULTS: Ninety-seven patients underwent follow-up at 5 years. Three others died during follow-up, 4 refused follow-up, and 8 were lost to follow-up; 89% remained at 5-years' follow-up. At 5 years' follow-up, mean analog scores for heartburn were 2.2 for anterior fundoplication vs 0.9 for Nissen fundoplication (P=.003). There were no significant differences between the groups for dysphagia scores. The mean score for outcome satisfaction was 7.1 after anterior fundoplication vs 8.1 after Nissen fundoplication (P=.18). Eighty-eight percent reported a good or excellent outcome following Nissen fundoplication vs 77% following anterior fundoplication. CONCLUSIONS: Laparoscopic Nissen and anterior 90 degrees partial fundoplication achieve similar levels of patient satisfaction at 5 years' follow-up, with similar adverse effect profiles. However, at 5 years' follow-up, laparoscopic Nissen fundoplication achieves superior control of reflux symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.

Quality of life following laparoscopic anterior 90 degrees versus Nissen fundoplication: results from a multicenter randomized trial.

BACKGROUND: The short-term clinical outcomes from a multicenter prospective randomized trial of laparoscopic Nissen versus anterior 90 degrees partial fundoplication have been reported previously. These demonstrated a high level of satisfaction with the overall outcome following anterior 90 degrees fundoplication. However, the results of postoperative objective tests and specific clinical symptoms are not always consistent with an individual patient's functional status and general well being following surgery, and quality of life (QOL) is also an important outcome to consider following surgery for reflux. Hence, QOL information was collected in this trial to investigate the hypothesis: improvements in QOL following laparoscopic antireflux surgery are greater after anterior 90 degrees partial fundoplication than after Nissen fundoplication. METHODS: Patients undergoing a laparoscopic fundoplication for gastro-esophageal reflux at one of nine university teaching hospitals in six major cities in Australia and New Zealand were randomized to undergo either laparoscopic Nissen or anterior 90 degrees partial fundoplication. Quality of life before and after surgery was assessed using validated questionnaires - the Short Form 36 general health questionnaire (SF36) and an Illness Behavior Questionnaire (IBQ). Patients were asked to complete these questionnaires preoperatively and at 3, 6, 12 and 24 months postoperatively. RESULTS: One hundred and twelve patients were randomized to undergo a Nissen fundoplication (52) or a 90 degrees anterior fundoplication (60). Patients who underwent anterior fundoplication reported significant improvements in eight of the nine SF36 scales compared to four of the nine following a Nissen fundoplication. The majority of these improvements occurred early in the postoperative period. With respect to the illness behavior data, there were no significant differences between the two procedures. Both groups had a significant improvement in disease conviction scores at all time points compared to their preoperative scores. CONCLUSIONS: Patients undergoing laparoscopic anterior 90 degrees partial fundoplication reported more QOL improvements in the early postoperative period than patients undergoing a Nissen fundoplication. However, the QOL outcome for both procedures was similar at later follow-up.

Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication.

HYPOTHESIS: Laparoscopic anterior 90 degrees partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication. DESIGN: A multicenter, prospective, double-blind, randomized controlled trial. SETTING: Nine university teaching hospitals in 6 major cities in Australia and New Zealand. PARTICIPANTS: One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were randomized to undergo either a Nissen (52 patients) or an anterior 90 degrees partial procedure (60 patients). Patients with esophageal motility disorders, patients requiring a concurrent abdominal procedure, and patients who had undergone previous antireflux surgery were excluded from this study. INTERVENTIONS: Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication. MAIN OUTCOME MEASURES: Independent assessment of dysphagia, heartburn, and overall satisfaction 1, 3, and 6 months after surgery using multiple clinical grading systems. Objective measurement of esophageal manometric parameters, esophageal acid exposure, and endoscopic assessment. RESULTS: Postoperative dysphagia, and wind-related adverse effects were less common after a laparoscopic anterior 90 degrees partial fundoplication. Relief of heartburn was better following laparoscopic Nissen fundoplication. Overall satisfaction was better after anterior 90 degrees partial fundoplication. Lower esophageal sphincter pressure, acid exposure, and endoscopy findings were similar for both procedures. CONCLUSIONS: At the 6-month follow-up, laparoscopic anterior 90 degrees culine partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization, and it achieves a higher rate of satisfaction with the overall outcome. However, this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms.