MANTA-TRIAL; Randomized Controlled Trial of laparoscopic Toupet versus Anterior Fundoplication for Gastroesophageal Reflux Disease

MANTA-TRIAL; Randomized Controlled Trial of laparoscopic Toupet versus Anterior Fundoplication for Gastroesophageal Reflux Disease - MANTA-TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39080

Enrollment

Registered

2012-07-12

Start date

2012-08-10

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysphagia reflux

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Proven gastroesophageal reflux disease by either endoscopy or 24 hour pH monitoring. - Clinically indicated anti-reflux surgery - Fit for surgery - Reflux disease inadequately controlled by medication of unwillingness to take lifelong medication

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
Objective reflux control, dysphagia and gas related symptoms are the main study endpoints.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)