OBJECTIVE: To evaluate late outcomes from a randomized trial of division versus no division of short gastric vessels during laparoscopic Nissen fundoplication at up to 20 years follow-up. BACKGROUND:Nissen fundoplication is an established procedure for the treatment of gastroesophageal reflux disease. Controversy about whether side effects such as dysphagia could be reduced by division of the short gastric vessels led to the establishment of a randomized trial in 1994. Early results showed equivalent reflux control and dysphagia, but more bloating after vessel division. METHODS: A total of 102 patients underwent alaparoscopic Nissen fundoplicationbetween May 1994 and October 1995, and were randomized to short gastric vessel division (50) versus nondivision (52). Follow-up was obtained yearly to 20 years using a standardized questionnaire administered by a blinded investigator. Clinical outcomes at 20 years or most recent follow-up were determined. RESULTS: No significant differences for heartburn symptom and satisfaction scores or medication use were found between treatment groups. At 15 to 20 (mean 19.6) years follow-up, significant differences persisted for epigastric bloating: 26% versus 50% for nondivision versus division groups (P = 0.046). Heartburn symptom scores were low and not different for nondivision versus division groups (mean analog scores 1.4 vs 2.1/10, P = 0.152). Overall satisfaction after surgery was high in both groups (mean analog scores 8.1 vs 8.6/10, P = 0.989). CONCLUSIONS: Although laparoscopic Nissen fundoplication has durable efficacy for heartburn symptom control at up to 20 years follow-up, division of short-gastric vessels failed to confer any reduction in side effects, and was associated with persistent epigastric bloat symptoms at late follow-up in this trial.
RCT Entities:
OBJECTIVE: To evaluate late outcomes from a randomized trial of division versus no division of short gastric vessels during laparoscopic Nissen fundoplication at up to 20 years follow-up. BACKGROUND: Nissen fundoplication is an established procedure for the treatment of gastroesophageal reflux disease. Controversy about whether side effects such as dysphagia could be reduced by division of the short gastric vessels led to the establishment of a randomized trial in 1994. Early results showed equivalent reflux control and dysphagia, but more bloating after vessel division. METHODS: A total of 102 patients underwent a laparoscopic Nissen fundoplication between May 1994 and October 1995, and were randomized to short gastric vessel division (50) versus nondivision (52). Follow-up was obtained yearly to 20 years using a standardized questionnaire administered by a blinded investigator. Clinical outcomes at 20 years or most recent follow-up were determined. RESULTS: No significant differences for heartburn symptom and satisfaction scores or medication use were found between treatment groups. At 15 to 20 (mean 19.6) years follow-up, significant differences persisted for epigastric bloating: 26% versus 50% for nondivision versus division groups (P = 0.046). Heartburn symptom scores were low and not different for nondivision versus division groups (mean analog scores 1.4 vs 2.1/10, P = 0.152). Overall satisfaction after surgery was high in both groups (mean analog scores 8.1 vs 8.6/10, P = 0.989). CONCLUSIONS: Although laparoscopic Nissen fundoplication has durable efficacy for heartburn symptom control at up to 20 years follow-up, division of short-gastric vessels failed to confer any reduction in side effects, and was associated with persistent epigastric bloat symptoms at late follow-up in this trial.
Authors: Bethany J Slater; Rebecca C Dirks; Sophia K McKinley; Mohammed T Ansari; Geoffrey P Kohn; Nirav Thosani; Bashar Qumseya; Sarah Billmeier; Shaun Daly; Catherine Crawford; Anne P Ehlers; Celeste Hollands; Francesco Palazzo; Noe Rodriguez; Arianne Train; Eelco Wassenaar; Danielle Walsh; Aurora D Pryor; Dimitrios Stefanidis Journal: Surg Endosc Date: 2021-07-19 Impact factor: 4.584