MANTA/TRIAL, Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease

Rationale: Laparoscopic partial fundoplications for gastroesophageal reflux disease like Toupet and Anterior fundoplication ensure long-term reflux control and reduce the risk of troublesome side effects. It is unclear which of both partial fundoplications is superior.



Objective: To define the optimum laparoscopic anti-reflux operation, ensuring long-term reflux control with minimal postoperative dysphagia and gas-related symptoms.



Study design: Multicenter prospective blinded randomized clinical superiority trial comparing two laparoscopic procedures for gastroesophageal reflux disease.



Study population: Adult patients with objectified gastroesophageal reflux disease proven by either endoscopy or 24 hour pH monitoring.



Intervention: Patients will be randomized to undergo a laparoscopic Toupet or Anteriour fundoplication. Both operations are clinically accepted operations according to standard clinical indications.

Main study parameters/endpoints: Objective reflux control, dysphagia and gas related symptoms are the main study endpoints. Patients will undergo prior to the surgery a manometry and 24 hour pH monitoring or combined pH-impedance monitoring similar to normal clinical practice. Questionnaires will be filled in pre-operatively and at 1, 3, 6, 12 months post-operatively and then yearly for up to 20 years. Furthermore undergo patients similar to normal post-operative follow-up a endoscopy, pH monitoring or combined pH-impedance and manometry at 3 months after surgery.

To define the optimum laparoscopic anti-reflux operation, ensuring long-term reflux control with minimal postoperative dysphagia and gas-related symptoms

1, 3, 6, 12 months post-operatively and then yearly.

Patients will be randomized to undergo a laparoscopic Toupet or Anteriour fundoplication. Both operations are clinically accepted operations according to standard clinical indications.