Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Hiatal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01195545 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Veritas® Collagen Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series |
6; 2; 8 | — |
| SECONDARY Pre and Post-operative Symptoms |
14; 2 | — |
| SECONDARY Pre and Post-operative Symptoms |
14; 2 | — |
| SECONDARY Pre and Post-operative Symptoms |
14; 2 | — |
Summary
Eligibility Criteria
Inclusion Criteria
A. Subjects must have a documented symptomatic paraesophageal hernia that:
- 1. Is greater than 5 cm hiatal hernia on Upper Gastrointestinal (UGI) series
- 2. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
- 3. Has significant symptoms or signs of a paraesophageal hernia: heartburn, dysphagia, chest pain, shortness of breath, post-prandial abdominal pain, early satiety, odynophagia or chronic anemia
B. Consenting adult ≥18 years ~ documentation of informed consent will be recorded in the research records
C. Must be able to participate in follow-up evaluations (subjects must be fully cognitive)
D. Has a telephone
E. Free of cognitive or speech impairment
Exclusion Criteria
A. Previous operation of the esophagus or stomach
B. Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease)
C. Emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)
Data sourced from ClinicalTrials.gov (NCT01195545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.