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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:ObjectiveTo examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported.Study designPremenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394.Results254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05).ConclusionsMyomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

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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