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Published on: September 22, 2023
Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled
Thomas J Fyhn1,2, Morten Kvello3,4, Bjørn Edwin3,5,6
1Institute of Clinical Medicine, University of Oslo, Oslo, Norway. thomasfy@gmail.com.
Insights
Laparoscopic fundoplication (LF) in children shows higher recurrence rates and earlier recurrence compared to open fundoplication (OF). However, patient and parental satisfaction remain high for both surgical approaches long-term.
Area of Science:
- Pediatric surgery
- Gastrointestinal surgery
- Clinical outcomes research
Background:
- Lack of long-term outcome data comparing laparoscopic fundoplication (LF) and open fundoplication (OF) in children.
- Study addresses recurrence rates, re-interventions, medication use, symptoms, and satisfaction a decade post-randomization.
Purpose of the Study:
- To compare long-term outcomes of laparoscopic versus open fundoplication in pediatric patients.
- To evaluate recurrence rates, time to recurrence, re-intervention frequency, and patient-reported outcomes.
Main Methods:
- Cross-sectional, long-term follow-up of a two-center randomized controlled trial (RCT) (2003-2009).
- Patient/parent interviews and medical chart reviews for fundoplication-related events.
- Diagnostic confirmation for suspected recurrence.
Main Results:
- Significantly higher recurrence rates after LF (56%) compared to OF (31%) (p=0.004).
- Earlier median time to recurrence after LF (1.0 year) versus OF (5.1 years).
- High patient/parental satisfaction reported for both LF (81%) and OF (88%), independent of surgical approach.
Conclusions:
- Laparoscopic fundoplication is associated with a higher and earlier recurrence rate than open fundoplication in children.
- Despite differences in recurrence, long-term patient and parental satisfaction is equally high for both surgical methods.
Background:
Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF.
Methods:
Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained.
Clinicaltrials:
gov: NCT01551134.
Results:
Eighty-eight children, 56 (64%) boys, were randomized (LF 44, OF 44) at median 4.4 [interquartile range (IQR) 2.0-8.9] years. 46 (52%) had neurological impairment. Three were lost to follow-up before first scheduled control. Recurrence was significantly more frequent after LF (24/43, 56%) than after OF (13/42, 31%, p = 0.004). Median time to recurrence was 1.0 [IQR 0.3-2.2] and 5.1 [IQR 1.5-9.3] years after LF and OF, respectively. Eight (19%) underwent redo fundoplication after LF and three (7%) after OF (p = 0.094). Seventy patients/parents were interviewed median 11.9 [IQR 9.9-12.8] years postoperatively. Among these, use of anti-secretory drugs was significantly decreased from preoperatively after both LF (94% vs. 35%, p < 0.001) and OF (97% vs. 19%, p < 0.001). Regurgitation/vomiting were observed in 6% after LF and 3% after OF (p = 0.609), and heartburn in 14% after LF and 17% after OF (p = 1.000). Overall opinion of the surgical scars was good in both groups (LF: 95%, OF: 86%, p = 0.610). Patient/parental satisfaction with outcome was high, independent of surgical approach (LF: 81%, OF: 88%, p = 0.500).
Conclusions:
The recurrence rate was higher and recurrence occurred earlier after LF than after OF. Patient/parental satisfaction with outcome after both LF and OF was equally high.
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