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Tytuł pozycji:

Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial.

Tytuł:
Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial.
Autorzy:
Fyhn TJ; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. .; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway. .
Kvello M; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway.
Edwin B; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; The Intervention Centre, Oslo University Hospital, Oslo, Norway.; Department of Hepatopancreatobiliary Surgery, Oslo University Hospital, Oslo, Norway.
Schistad O; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway.
Pripp AH; Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.
Emblem R; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway.
Knatten CK; Department of Pediatrics, Oslo University Hospital, Oslo, Norway.
Bjørnland K; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, 4950, Nydalen, Oslo, 0424, Norway.
Źródło:
Surgical endoscopy [Surg Endosc] 2023 Jan; Vol. 37 (1), pp. 189-199. Date of Electronic Publication: 2022 Aug 01.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Publication: 1992- : New York : Springer
Original Publication: [Berlin] : Springer International, c1987-
MeSH Terms:
Gastroesophageal Reflux*/surgery
Gastroesophageal Reflux*/diagnosis
Laparoscopy*/adverse effects
Laparoscopy*/methods
Male ; Humans ; Child ; Female ; Fundoplication/methods ; Treatment Outcome ; Heartburn/surgery ; Vomiting ; Follow-Up Studies ; Randomized Controlled Trials as Topic
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Contributed Indexing:
Keywords: Child; Fundoplication; Gastroesophageal reflux; Laparoscopy; Randomized
Molecular Sequence:
ClinicalTrials.gov NCT01551134
Entry Date(s):
Date Created: 20220801 Date Completed: 20230117 Latest Revision: 20230302
Update Code:
20240105
PubMed Central ID:
PMC9839805
DOI:
10.1007/s00464-022-09458-6
PMID:
35915187
Czasopismo naukowe
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.
(© 2022. The Author(s).)

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