Valvuloplasty as alternative to Toupet fundoplication for the minimal invasive treatment of gastroesophageal reflux disease: a randomized controlled trial

Conditions: middenrif
Gastro-esophageal reflux disease
10018012
10017998

Registration Number: NL-OMON41979

Lead Sponsor: Meander Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

Adults with objectively proven gastroesophageal reflux disease and a maximum hiatal hernia of 3cm who are eligible for antireflux surgery.

Exclusion Criteria

High BMI (>=30), large hiatal hernia (>=3cm), achalasia, previous upper-GI surgery or inability to understand the Dutch language or fill in the questionnaires.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Success rate, objective (defined as % of patients with normal values of<br /><br>reflux measured by pH and impedance monitoring)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Success rate, subjective (defined as % of patients with Visick score I or II)<br /><br>- Dysphagia (% of patients with complaints of functional dysphagia following<br /><br>the Rome III criteria, duration is determined by absence of complaints and<br /><br>normalisation of diet)<br /><br>- Cost-effectiveness (determined using quality of life, duration of surgery,<br /><br>length of hospital stay, sick leave duration, medication usage, and other<br /><br>direct and indirect costs measured by iMTA MCQ/PCQ)<br /><br><br /><br>Safety<br /><br>- Mortality rate (defined as in-hospital mortality or out of hospital mortality<br /><br>within 30 days)<br /><br>- Complication rate (intra-operative complication rate)<br /><br>- Conversion rate<br /><br>- Disease related reoperation rate (% patients requiring redo surgery for<br /><br>persisting complaints or* recurrence)</p><br>