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

Maurizio Pacilli, Simon Eaton, Merrill McHoney, Edward M. Kiely, David P. Drake, Joseph I. Curry, Keith J. Lindley, Agostino Pierro

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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.

Original languageEnglish
Pages (from-to)516-521
Number of pages6
JournalArchives of Disease in Childhood
Volume99
Issue number6
DOIs
Publication statusPublished - Jun 2014
Externally publishedYes

Cite this

Pacilli, Maurizio ; Eaton, Simon ; McHoney, Merrill ; Kiely, Edward M. ; Drake, David P. ; Curry, Joseph I. ; Lindley, Keith J. ; Pierro, Agostino. / Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children. In: Archives of Disease in Childhood. 2014 ; Vol. 99, No. 6. pp. 516-521.
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title = "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.",
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Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children. / Pacilli, Maurizio; Eaton, Simon; McHoney, Merrill; Kiely, Edward M.; Drake, David P.; Curry, Joseph I.; Lindley, Keith J.; Pierro, Agostino.

In: Archives of Disease in Childhood, Vol. 99, No. 6, 06.2014, p. 516-521.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children

AU - Pacilli, Maurizio

AU - Eaton, Simon

AU - McHoney, Merrill

AU - Kiely, Edward M.

AU - Drake, David P.

AU - Curry, Joseph I.

AU - Lindley, Keith J.

AU - Pierro, Agostino

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N2 - 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.

AB - 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.

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