Laparoscopic Hernia Repair for Hiatal Hernia (PEHFLIP Trial)
Palo Alto (17 mi)Overseen byChristy M Dunst, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: The Foundation for Surgical Innovation and Education
No Placebo Group
Trial Summary
What is the purpose of this trial?Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.
Eligibility Criteria
This trial is for patients who need surgery to fix a paraesophageal hernia but haven't had this type of surgery before. They shouldn't have GERD (acid reflux) diagnosed by tests or a weak valve between the stomach and esophagus found during surgery.Treatment Details
The study is testing if it's beneficial to add a step called fundoplication when repairing a paraesophageal hernia laparoscopically, which involves folding the top part of the stomach around the esophagus.
2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
No Fundoplication
Group II: Control GroupActive Control1 Intervention
Fundoplication
Find a clinic near you
Research locations nearbySelect from list below to view details:
Providence Portland Medical Center / The Oregon ClinicPortland, OR
NorthShore University HealthSystemEvanston, IL
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Who is running the clinical trial?
The Foundation for Surgical Innovation and EducationLead Sponsor