To define the optimum laparoscopic anti-reflux operation, ensuring long-term reflux control with minimal postoperative dysphagia and gas-related symptoms.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective reflux control, dysphagia and gas related symptoms are the main study
endpoints.
Secondary outcome
not applicable
Background summary
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.
Study objective
To define the optimum laparoscopic anti-reflux operation, ensuring long-term
reflux control with minimal postoperative dysphagia and gas-related symptoms.
Study design
Prospective blinded randomized controlled superiority trial comparing two
laparoscopic procedures for gastroesophageal reflux disease.
Intervention
Patients will be randomized to undergo a laparoscopic Toupet or Anteriour
fundoplication. Both operations are clinically accepted operations according to
standard clinical indications.
Study burden and risks
: Included 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
Koekoekslaan 1
3430 EM Nieuwegein 3430 EM
NL
Koekoekslaan 1
3430 EM Nieuwegein 3430 EM
NL
Listed location countries
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
- Age < 18 years
- No informed consent
- Previous anti-reflux surgery
- Large hiatus hernia ( more than 50% of the stomach in the chest)
- Pregnant
- Esophageal aperistalsis
- Esophageal spasms or achalasia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL39193.100.12 |
| OMON | NL-OMON28375 |