Thomas J Fyhn1,2, Morten Kvello3,4, Bjørn Edwin3,5,6, Ole Schistad4, Are H Pripp7, Ragnhild Emblem3,4, Charlotte K Knatten8, Kristin Bjørnland3,4. 1. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. thomasfy@gmail.com. 2. Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway. thomasfy@gmail.com. 3. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 4. Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway. 5. The Intervention Centre, Oslo University Hospital, Oslo, Norway. 6. Department of Hepatopancreatobiliary Surgery, Oslo University Hospital, Oslo, Norway. 7. Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway. 8. Department of Pediatrics, Oslo University Hospital, Oslo, Norway.
Abstract
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.
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.
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
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