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


- candidate number24151
- NTR NumberNTR5702
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2016
- Secondary IDsNL39193.100.12 
- Public TitleMANTA/TRIAL, Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease
- Scientific TitleDouble-Blind Mulitcenter Randomized Clinical Trial of Laparoscopic Toupet versus 180˚ Anterior Fundoplication for Gastroesophageal Reflux Disease
- ACRONYMMANTA
- hypothesisTo 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) studiedGastroesophageal 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)
- Pregnant
- Esophageal aperistalsis
- Esophageal spasms or achalasia
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-aug-2012
- planned closingdate31-mei-2015
- Target number of participants94
- InterventionsPatients will be randomized to undergo a laparoscopic Toupet or Anteriour fundoplication. Both operations are clinically accepted operations according to standard clinical indications.
- Primary outcomeDysphagia 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.
- Timepoints1, 3, 6, 12 months post-operatively and then yearly.
- Trial web sitenon
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. D.J.G.H. Roks
- CONTACT for SCIENTIFIC QUERIESDrs. D.J.G.H. Roks
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- Publicationsnvt
- Brief summaryRationale: 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)
- RECORD26-mrt-2016 - 16-apr-2016


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