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Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children.

ABSTRACT: To evaluate the 4-year results following a randomised controlled trial (RCT) comparing open (ONF) and laparoscopic (LNF) Nissen fundoplication in children.It is assumed that long-term results of ONF and LNF are comparable. No randomised studies have been performed in children.A follow-up study was performed in children randomised to ONF or LNF (clinicaltrials.gov identifier NCT00259961). Recurrent gastro-oesophageal reflux (GER) was documented by upper gastrointestinal contrast study and/or 24-h pH study. Nutritional status, retching and other symptoms were investigated. A questionnaire was used to assess the quality of life before and after surgery.Thirty-nine children were randomised to ONF (n=20) or LNF (n=19). There were 15 ONF and 16 LNF neurologically impaired children. One patient (ONF group) was lost to follow-up. Follow-up was 4.1?years (3.1-5.3) for ONF group and 4.1?years (2.6-5.1) for LNF group (p=0.9). Seven neurologically impaired children had died by the time of follow-up (3 ONF, 4 LNF). Incidence of recurrent GER was 12.5% in the ONF and 20% in the LNF (p=ns). One patient in each group underwent redo-Nissen fundoplication. Nutritional status improved in both groups, as indicated by a significant increase in weight Z-score (p<0.01). Gas bloat and dumping syndrome were present in both groups (p=ns). Incidence of retching was lower in the laparoscopic group (p=0.01). Quality of life improved in both groups (p=ns).Open and laparoscopic Nissen provide similar control of reflux and quality of life at follow-up. LNF is associated with reduced incidence of retching persisting at 4-year follow-up.NCT00259961.

SUBMITTER: Pacilli M

PROVIDER: S-EPMC4033109 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children.

Pacilli Maurizio M Eaton Simon S McHoney Merrill M Kiely Edward M EM Drake David P DP Curry Joseph I JI Lindley Keith J KJ Pierro Agostino A

Archives of disease in childhood 20140214 6

<h4>Objective</h4>To evaluate the 4-year results following a randomised controlled trial (RCT) comparing open (ONF) and laparoscopic (LNF) Nissen fundoplication in children.<h4>Background</h4>It is assumed that long-term results of ONF and LNF are comparable. No randomised studies have been performed in children.<h4>Methods</h4>A follow-up study was performed in children randomised to ONF or LNF (clinicaltrials.gov identifier NCT00259961). Recurrent gastro-oesophageal reflux (GER) was documented ...[more]

PMID: 24532685

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Project description: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. 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. gov: NCT01551134. 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). 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.

Dataset Information

Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children.

Publications

Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children.

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