OBJECTIVE: To compare the effect of laparoscopic Nissen and Lind fundoplication on gastro-oesophageal reflux disease by means of a prospective randomized controlled trial. MATERIAL AND METHODS: One hundred and twenty-one patients were randomized to undergo either Nissen (61) or Lind (60) fundoplication. Initial enrollment and subsequent clinical appointments were undertaken 1, 3, 6 and 12 months after the procedure using a standardized questionnaire. Ambulatory pH monitoring and manometry were undertaken both preoperatively and at approximately 3 months post-procedure. RESULTS: The mean operating time was similar in both groups (44.8 versus 45 min). One operation in the Lind group was converted to open surgery. Postoperative dysphagia symptoms at 3 and 6 months were higher in the Nissen fundoplication group than in the Lind group (3 months p=0.003; 6 months p=0.020). The time taken to return to work was statistically longer in the Nissen group: at 1 month, 9 of 40 versus 2 of 45 patients had not returned to full activities (p=0.013). Three individuals required re-operation in the Nissen group and 4 individuals in the Lind group because of dysphagia caused by mechanical obstruction. Both procedures demonstrated good Visick scores at 12 months; the Nissen group having 33 (97%) patients with a Visick score of 1 or 2, and the Lind group having 38 (100%) patients with a Visick score of 1 or 2. CONCLUSIONS: Both operations provide good quantitative and qualitative control of gastro-oesophageal reflux. Operation time and postoperative comparators were similar in both groups. There were no statistically significant differences between the groups at 1 year.
RCT Entities:
OBJECTIVE: To compare the effect of laparoscopic Nissen and Lind fundoplication on gastro-oesophageal reflux disease by means of a prospective randomized controlled trial. MATERIAL AND METHODS: One hundred and twenty-one patients were randomized to undergo either Nissen (61) or Lind (60) fundoplication. Initial enrollment and subsequent clinical appointments were undertaken 1, 3, 6 and 12 months after the procedure using a standardized questionnaire. Ambulatory pH monitoring and manometry were undertaken both preoperatively and at approximately 3 months post-procedure. RESULTS: The mean operating time was similar in both groups (44.8 versus 45 min). One operation in the Lind group was converted to open surgery. Postoperative dysphagia symptoms at 3 and 6 months were higher in the Nissen fundoplication group than in the Lind group (3 months p=0.003; 6 months p=0.020). The time taken to return to work was statistically longer in the Nissen group: at 1 month, 9 of 40 versus 2 of 45 patients had not returned to full activities (p=0.013). Three individuals required re-operation in the Nissen group and 4 individuals in the Lind group because of dysphagia caused by mechanical obstruction. Both procedures demonstrated good Visick scores at 12 months; the Nissen group having 33 (97%) patients with a Visick score of 1 or 2, and the Lind group having 38 (100%) patients with a Visick score of 1 or 2. CONCLUSIONS: Both operations provide good quantitative and qualitative control of gastro-oesophageal reflux. Operation time and postoperative comparators were similar in both groups. There were no statistically significant differences between the groups at 1 year.