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Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in
Maurizio Pacilli1, Simon Eaton1, Merrill McHoney1
1Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
Insights
Open and laparoscopic Nissen fundoplication show similar long-term reflux control and quality of life in children. Laparoscopic Nissen fundoplication (LNF) resulted in less retching at 4-year follow-up.
Area of Science:
- Pediatric surgery
- Gastroenterology
- Comparative effectiveness research
Background:
- Long-term outcomes of open (ONF) versus laparoscopic Nissen fundoplication (LNF) in children are assumed comparable.
- No prior randomized controlled trials (RCTs) have directly compared these techniques in pediatric populations.
Purpose of the Study:
- To evaluate and compare the 4-year outcomes of open and laparoscopic Nissen fundoplication in children.
- Assess recurrence of gastro-oesophageal reflux (GER), nutritional status, and quality of life post-surgery.
Main Methods:
- A follow-up study of children randomized to ONF or LNF (NCT00259961).
- Recurrent GER assessed via upper GI contrast study and/or 24-h pH monitoring.
- Nutritional status, retching, and quality of life evaluated using objective measures and questionnaires.
Main Results:
- Thirty-nine children (20 ONF, 19 LNF) were followed for a mean of 4.1 years.
- Recurrent GER incidence was 12.5% (ONF) and 20% (LNF) (p=ns).
- Nutritional status improved significantly in both groups (p<0.01); retching was significantly lower in the LNF group (p=0.01).
Conclusions:
- Both open and laparoscopic Nissen fundoplication offer comparable long-term control of reflux and improvements in quality of life.
- Laparoscopic Nissen fundoplication demonstrates a reduced incidence of persistent retching at the 4-year follow-up.
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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