Long-term outcome of laparoscopic nissen fundoplication compared with laparoscopic thal fundoplication in children: a prospective, randomized study.

BACKGROUND: Laparoscopic fundoplication is increasingly performed in pediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. To date there has been no prospective randomized study to determine the optimal laparoscopic technique in children. The aim of the study was to compare the long-term outcomes and control of symptoms after laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.
METHODS: Between July 1998 and April 2007, 175 patients were recruited to this prospective, randomized study. Patients were assessed before the operation and after defined intervals starting at 3 months after surgery. The "absolute" outcome measure for fundoplication failure was recurrence of symptoms that merited a redofundoplication or insertion of a transgastric jejunostomy. "Relative" outcome measures were recurrence of symptoms necessitating reintroduction of antireflux medication (ie, "intention to treat") and postoperative complications (eg, postoperative dysphagia). The median follow-up time was 30 months (range, 1-109). This study has been registered with clinicaltrials.gov (NCT01027975).
RESULTS: Long-term results were available in 167 patients of which 85 underwent a Nissen and 82 a Thal fundoplication. Four patients in the Nissen group (4.7%) and 12 in the Thal group (14.6%) required a redofundoplication. One child in each group developed recurrence of symptoms and had a transgastric jejunostomy performed. The "absolute" failure rate was significant lower in the Nissen group (n = 5; 5.9%) compared with the Thal group (n = 13; 15.9%) (P = 0.038). The vast majority of these patients (17 of 18) had underlying neurological disorders. The "relative" failure rate (ie, "intention to treat") was similar in both groups. Nearly one-quarter of patients developed postoperative dysphagia similarly distributed between both groups. However, severe dysphagia requiring endoscopy +/- dilatation was significantly higher in the Nissen group (n = 10, 11.8%) compared with the Thal group (n = 2; 2.4%) (P = 0.020). One of 31 deaths (0.6%) in this series occurred after surgery, but was not directly related to the fundoplication technique.
CONCLUSIONS: In the long-term a laparoscopic Nissen fundoplication had a significantly lower recurrence rate than a Thal fundoplication, particularly in patients with underlying neurological disorders. There was no significant difference between the 2 types of fundoplication in normal children. There was no significant difference between the need for restarting antireflux medication between both groups because of recurrence of moderate symptoms. The incidence of postoperative dysphagia was similar in the 2 groups, however, significantly more patients in the Nissen group required intervention for severe dysphagia. Overall the perioperative death rate was low even in high-risk patients.

RCT Entities:   Population Interventions Outcomes