Status:
COMPLETED
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Synovis Surgical Innovations
Conditions:
Hiatal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repa...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01195545
Start Date
May 1 2010
End Date
December 1 2013
Last Update
July 10 2018
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195