|- candidate number||24151|
|- NTR Number||NTR5702|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2016|
|- Secondary IDs||NL39193.100.12 |
|- Public Title||MANTA/TRIAL, Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease|
|- Scientific Title||Double-Blind Mulitcenter Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease|
|- hypothesis||To define the optimum laparoscopic anti-reflux operation, ensuring long-term reflux control with minimal postoperative dysphagia and gas-related symptoms|
|- Healt Condition(s) or Problem(s) studied||Gastroesophageal reflux Disease (GERD)|
|- 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)
- Esophageal aperistalsis
- Esophageal spasms or achalasia
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-aug-2012|
|- planned closingdate||31-mei-2015|
|- Target number of participants||94|
|- Interventions||Patients will be randomized to undergo a laparoscopic Toupet or Anteriour fundoplication. Both operations are clinically accepted operations according to standard clinical indications.|
|- Primary outcome||Dysphagia score after 6 months|
|- Secondary outcome||- Objective reflux control|
- Gas-related symptoms
- Subjective reflux control
- Esophageal motility
- Intraluminal pressure in the region of the fundoplication
- Postoperative PPI use
- Reintervention for dysphagia or recurrent reflux disease
- Patient satisfaction
- Major complications
- duration of operation
- in-hospital stay
- minor complications, including superficial wound infection, urinary tract infection, bleeding without need for blood transfusion or re-intervention.
|- Timepoints||1, 3, 6, 12 months post-operatively and then yearly.|
|- Trial web site||non|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. D.J.G.H. Roks|
|- CONTACT for SCIENTIFIC QUERIES||Drs. D.J.G.H. Roks|
|- Sponsor/Initiator ||St. Antonius Hospital|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||26-mrt-2016 - 16-apr-2016|