Related Experiment Videos
A prospective randomized double-blind study of gastroesophageal reflux surgery in pediatric-sized developmentally
Insights
Both Nissen fundoplication and Angelchik antireflux prosthesis are effective for treating gastroesophageal reflux in children. Long-term studies show similar outcomes, with no significant differences in complications or symptom improvement.
Area of Science:
- Pediatric Surgery
- Gastroenterology
- Medical Devices
Background:
- Gastroesophageal reflux disease (GERD) is a common condition in pediatric patients, often requiring surgical intervention.
- The Nissen fundoplication is a standard surgical procedure for GERD, while the Angelchik antireflux prosthesis is a more recent alternative.
Purpose of the Study:
- To prospectively compare the efficacy and safety of the Nissen fundoplication versus the Angelchik antireflux prosthesis in pediatric patients.
- To evaluate short-term and long-term outcomes, including reflux control, patient well-being, and complication rates.
Main Methods:
- A prospective randomized study involving 47 pediatric patients with GERD.
- Patients were randomized to receive either Nissen fundoplication or the Angelchik antireflux prosthesis.
- Outcomes were assessed at 6 months and 12-30 months post-surgery, including pH monitoring, clinical assessments, and complication tracking.
Main Results:
- The Angelchik group had significantly shorter anesthesia times compared to the Nissen group (107.4 vs. 156.5 minutes).
- At 6 months and long-term follow-up (12-30 months), both procedures demonstrated comparable improvements in reflux control, weight gain, and reduction in emesis.
- No significant difference in complication rates was observed between the two groups (1/21 for Angelchik, 1/17 for Nissen).
Conclusions:
- Both Nissen fundoplication and the Angelchik antireflux prosthesis are generally effective in the surgical management of GERD in pediatric patients.
- While the Angelchik prosthesis offers reduced anesthesia time, long-term superiority of one procedure over the other could not be established.
- Further research is warranted to determine the long-term efficacy and potential advantages of each surgical approach.
Abstract:
In order to compare the standard Nissen fundoplication with the more recent Angelchik antireflux prosthesis, 47 pediatric-sized, developmentally disabled patients were prospectively randomized to receive either of these gastroesophageal antireflux procedures. The two groups were comparable at the time of surgery with regard to age, weight, surface area, emesis, number of chest radiographs, medications, lower esophageal sphincter pressure, and number and duration of reflux episodes during standard acid reflux testing. The Angelchik group required significantly less anesthesia time than the Nissen group: 107.4 +/- 22.6 min (mean +/- SD) versus 156.5 +/- 42.4 min (p less than 0.001). There was no difference in length of postsurgical hospital stay. Six months after surgery, both groups showed improvement. There was no significant difference between the Angelchik and Nissen groups in mean subjective assessment score, increased weight gain, decreases in emesis, numbers of chest radiographs, hospital days, or medications, increased lower esophageal sphincter pressure, or decreased numbers and duration of reflux during acid reflux testing. Long-term follow-up of eight Angelchik and 10 Nissen patients 12-30 months postsurgery (Angelchik 21.6 +/- 6.0 months, Nissen 21.9 +/- 5.0 months) demonstrated no significant difference in the percent of time the distal esophageal pH was below 4.0. Significant complications potentially related to the type of procedure developed in 1/21 patients in the Angelchik group and 1/17 patients in the Nissen group. We conclude that both procedures are usually effective for the surgical treatment of gastroesophageal reflux. Further study is indicated in order to establish the long-term superiority of one procedure.