Prospective randomized trial of Nissen fundoplication and Angelchik prosthesis in the surgical treatment of medically refractory gastro-oesophageal reflux disease

Abstract

Fifty patients with gastro-oesophageal reflux disease refractory to multiple courses of medical therapy were entered into a prospective randomized trial comparing Nissen fundoplication with the Angelchick prosthesis as a primary surgical procedure. The two groups were matched for age, sex, duration of symptoms before surgery, type of medical therapy, pattern of symptom presentation, endoscopic grade of oesophageal inflammation, manometric lower oesophageal pressure and 24-h pH profile. Twenty-five patients were randomized to each of the Nissen fundoplication and Angelchik prosthesis groups. Operation time and hospital stay were similar in both groups. Persistent dysphagia was reported in five of the patients with an Angelchik prosthesis compared with none in the Nissen fundoplication group. Three prostheses were removed because of severe dysphagia while no Nissen fundoplication required revision. No patient with preoperative dysphagia because of stricture reported swallowing difficulties after operation. At clinical assessment at 3, 6, 12 and 24 months after operation, 85-88 per cent of the patients having a Nissen fundoplication were graded Visick 1 or 2 compared with 60-72 per cent of patients in the Angelchik group.

Symptomatic improvement in gastroesophageal reflux disease (GERD) following laparoscopic Roux-en-Y gastric bypass

“…Reports of the laparoscopic adjustable gastric banding operations seem to be con¯icting. In theory, the adjustable band prevents re¯ux in a manner similar to the, 3 Angelchick prosthesis, which is placed around the lower esophagus rather than the upper stomach [16]. Dixon and O'Brien reported 90% resolution or improvement in GERD in 48 patients who underwent laparoscopic gastric banding with a preoperative diagnosis of GERD [8].…”

Laparoscopic removal of an Angelchik prosthesis

“…Other investigators have reported a reoperation rate of 5-15%, with dysphagia also representing the most common reason for Angelchik removal [5, 7-9, 15, 16]. Five prospective randomized trials comparing the Angelchik ring with Nissen fundoplication [6][7][8][9]16] indicated that the Angelchik prosthesis relieves GERD symptoms as well as the Nissen procedure in the early postoperative period. However, several investigators believe that, unlike Nissen fundoplication, the incidence of dysphagia increases over time in patients with the Angelchik ring, most likely due to the formation of dense fibrous pseudocapsules around the silicone prostheses [4,13,17].…”

“…Although several studies have suggested that the Angelchik ring provides early postoperative control of GERD symptoms as well as the Nissen fundoplication (NF), reoperation for removal of Angelchik rings due to dysphagia has been necessary in 5-15% of patients [5][6][7][8][9]16]. Furthermore, the Angelchik prosthetic ring has been associated with other complications, including migration into the mediastinum and distant sites within the peritoneal cavity, as well as erosion into the gastrointestinal tract.…”

Offene Antirefluxchirurgie

“…In mehreren randomisierten Arbeiten fiel u È berdies das funktionelle Langzeitergebnis der Angelchick-Prothese gegenu È ber der Nissen-Fundoplicatio signifikant schlechter aus [27,34,52]. 6) [4].…”