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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41979

Enrollment

160

Registered

2015-10-09

Start date

2015-11-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

middenrif Gastro-esophageal reflux disease

Interventions

Laparoscopic gastroesophageal valvuloplasty: Via laparoscopy, using three sutures a part of the esophagus is folded (similar to the way parts of a telescope slide in each other) into the stomach, cr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
- Success rate, objective (defined as % of patients with normal values of reflux measured by pH and impedance monitoring)	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)