Randomized controlled trial comparing Nissen fundoplication and the Angelchik prosthesis

Area of Science:

• Gastroenterology
• Surgical Innovation
• Reflux Management

Background:

• Gastro-oesophageal reflux disease (GERD) poses a significant challenge when refractory to medical therapy.
• Surgical interventions are considered for persistent GERD symptoms.
• Comparative efficacy of different surgical approaches requires ongoing investigation.

Purpose of the Study:

• To compare the long-term efficacy of Rossetti-Hell modification of Nissen fundoplication versus the Angelchik prosthesis for refractory GERD.
• To evaluate patient outcomes, symptom control, and adverse events associated with each surgical method.

Main Methods:

• Prospective randomized trial involving 61 patients with refractory GERD.
• Comparison between Nissen fundoplication (n=31) and Angelchik prosthesis (n=30).
• Long-term follow-up (mean 84 months) including clinical review, endoscopy, 24-h esophageal pH monitoring, and manometry.

Main Results:

• Both Nissen fundoplication and Angelchik prosthesis provided lasting control of gastro-oesophageal reflux.
• Satisfactory outcomes were achieved in 20 patients with fundoplication and 17 with the Angelchik prosthesis.
• No significant differences in pH profiles were observed; however, three Angelchik prostheses required removal.

Conclusions:

• Both surgical techniques offer durable solutions for medically refractory GERD.
• Nissen fundoplication and Angelchik prosthesis demonstrate comparable long-term efficacy in reflux control.
• While effective, the Angelchik prosthesis carries a risk of requiring removal.