Critical Appraisal
Article Title: Fundoplication in Pediatric Achalasia Patients Undergoing Heller’s Myotomy: A
Systematic Review
Authors: Susanto S, O’Connor B, Teague WJ
Published in: Archives of Pediatric Gastroenterology, Hepatology, and Nutrition, Vol. 2, No. 2,
May 2023
DOI: https://doi.org/10.58427/apghn.2.2.2023.1-17
I. Introduction
1. Does the article address a clearly focused question?
Yes. The article examines whether the addition of fundoplication to Heller’s myotomy (HM)
in children with achalasia leads to better clinical outcomes and fewer GERD-related
complications.
2. Is the article recent or a key paper in the field?
Yes. It was published in 2023, making it both recent and relevant.
3. Is the journal peer-reviewed?
Yes. The Archives of Pediatric Gastroenterology, Hepatology, and Nutrition is a peer-
reviewed medical journal.
4. Does the study clearly state its research question or hypothesis?
Yes. The aim was to assess whether fundoplication improves outcomes and reduces GERD
in pediatric achalasia patients undergoing HM.
II. Methodology
5. Population and Subjects
Target and accessible population: Children (ages 0–18 years) diagnosed with achalasia who
underwent Heller’s myotomy, either with or without fundoplication.
Inclusion criteria: Studies involving pediatric patients (<18 years) with achalasia treated
with Heller’s myotomy.
Exclusion criteria: Non-human studies, non-English studies, publications before 2006,
patients older than 18 years, and studies without data on pre/postoperative symptoms or
not involving Heller’s myotomy.
6. Study Design
Study type: Systematic review conducted according to PRISMA guidelines.
Randomization methods: Not applicable due to the nature of a systematic review.
Randomization tools: Not applicable.
Who conducted randomization and any concealment? Not applicable.
Blinding: No blinding was reported; however, data extraction was done independently.
7. Sample Size
Sample size formula: Not calculated, as this is a systematic review, not a clinical trial.
Rationale for sample size: A total of 21 studies with 410 patients were included based on
strict eligibility criteria, reflecting a comprehensive literature selection.
8. Analysis Plan
Statistical tests used: No specific statistical tests (e.g., t-test or chi-square) were reported;
data were analyzed descriptively and comparatively between HM and HMF groups.
Analysis methods: No mention of per-protocol or intention-to-treat analysis; results were
based on extracted data from included studies.
Software used: Not reported.
Planned interim analysis: None mentioned.
III. Results
9. How many subjects were assigned to each group?
Heller’s Myotomy only (HM): 80 patients
Heller’s Myotomy + Fundoplication (HMF): 330 patients
10. How many and what percentage completed the study?
HMF group: 120/330 patients (36.4%) had follow-up data
HM group: 32/80 patients (40%) had follow-up data
11. How many and what percentage did not complete the study?
Not explicitly stated, but many patients were lost to follow-up or had incomplete data in
various outcome domains.
Reasons for exclusion from the study?
Patients aged over 18
Patients not undergoing Heller’s myotomy
Lack of data on pre- and postoperative symptoms
Non-English studies or those published before 2006
12. Were baseline data comparable?
Not fully comparable; there were variations in age, sex, and preoperative treatment history
across studies.
For instance, 33.3% of HMF patients had prior treatments (e.g., botulinum toxin injection),
compared to only 8.8% in HM.
13. What was done if baseline data were not comparable?
No formal adjustment or subgroup analysis was performed; potential confounding was
addressed in the discussion section.
14. What are the primary outcomes?
Resolution of achalasia symptoms (asymptomatic rate)
Postoperative GERD occurrence
15 Are they statistically or clinically significant?
No statistical testing was reported.
Clinically:
HM showed a higher asymptomatic rate (56.3%) compared to HMF (48.8%).
GERD incidence was lower in HMF (9.7%) than in HM (15%), but this was considered
clinically insignificant by the authors.
16. What are the secondary outcomes?
Intra- and postoperative complications (e.g., mucosal perforation, infection, pneumonia,
retrosternal pain)
Postoperative dysphagia
Weight gain
Length of hospital stay
Symptom recurrence
IV. Discussion and Conclusion
18. Did the authors avoid over-interpreting non-significant results?
Yes. They acknowledged that the slight reduction in GERD incidence with fundoplication
was not clinically meaningful.
19. Do the authors discuss study limitations?
Yes. They recognize limitations such as patient heterogeneity, imbalance in group sizes, and
lack of randomized controlled trials.
20. Were conflicts of interest disclosed?
Yes. The authors declared no conflicts of interest.
Overall Appraisal Summary
This systematic review is methodologically sound and clinically relevant, providing useful
insights into the limited benefit of adding fundoplication to Heller’s myotomy in pediatric
achalasia patients. Although GERD symptoms were slightly lower in the fundoplication
group, symptom resolution was actually more frequent in the HM-only group. The study's
conclusions are well-balanced, though further high-quality prospective or randomized trials
are needed to confirm these findings.
