Dataset Information

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

ABSTRACT:

Objective

To evaluate the 4-year results following a randomised controlled trial (RCT) comparing open (ONF) and laparoscopic (LNF) Nissen fundoplication in children.

Background

It is assumed that long-term results of ONF and LNF are comparable. No randomised studies have been performed in children.

Methods

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.

Results

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).

Conclusions

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.

Trial registration number

NCT00259961.

SUBMITTER: Pacilli M

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

REPOSITORIES: biostudies-literature

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Publications

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.

Project description:BackgroundEven in the absence of definite evidence of pathological acid reflux, antireflux surgery (ARS) can still effectively improve gastroesophageal reflux symptoms. Nonetheless, predicting postoperative reflux symptom improvement has been primarily dependent on acid-based parameters. No objective index reflecting both acid and non-acid reflux was identified to select ARS candidates.Materials and methodsProspectively collected data of 121 patients with gastroesophageal reflux disease (GERD), who underwent laparoscopic Nissen fundoplication from two institutions, were retrospectively reviewed. The patients reported preoperative and postoperative GERD symptoms using the Korean version of the GERD questionnaire, along with the gastroesophageal reflux disease-health-related quality of life (GERD-HRQL). The patients assessed for reflux symptoms using bolus exposure, acid exposure time (AET), and DeMeester score (DMS) as measurements were selected. For each reflux parameter, its association, correlation, and predictive capacity of the degree of postoperative symptom resolution were analyzed using chi-squared tests, point-biserial correlations, logistic regression analyses, and receiver operating characteristic curve analyses.Results72 patients were eligible for this study. Bolus exposure was superior to the other parameters in terms of the degree of association and correlation with resolution of typical symptoms. Bolus exposure also showed a higher diagnostic accuracy in predicting the resolution of epigastric pain (area under the curve [AUC]=0.723, P=0.013) and regurgitation (AUC=0.981, P<0.001). Secondary analyses were performed in patients without pathological reflux, defined as the DMS-negative (DMS<14.7) or AET-negative (AET<6%) groups. In the secondary analyses, bolus exposure showed considerable diagnostic accuracy with statistical significance for all typical symptoms in both in the DMS-negative (heartburn: AUC=0.717, P=0.025; epigastric pain: AUC=0.717, P=0.025; regurgitation: AUC=0.975, P<0.001) and AET-negative (heartburn: AUC=0.681, P=0.045; epigastric pain: AUC=0.749, P=0.009; regurgitation: AUC=0.975, P<0.001) groups.ConclusionBolus exposure, a parameter of total reflux, was superior to AET or DMS in defining candidates for ARS. Further studies investigating the surgical indications for ARS in patients with non-acid reflux using bolus exposure are required.

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Dataset Information

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

Objective

Background

Methods

Results

Conclusions

Trial registration number

Publications

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

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