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Procedure
Laparoscopic Hernia Repair for Hiatal Hernia (PEHFLIP Trial)
N/A
Waitlist Available
Led By Christy M Dunst, MD
Research Sponsored by The Foundation for Surgical Innovation and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PEHFLIP Trial Summary
This trial will look at whether a fundoplication should be done during laparoscopic hernia repair, and if it's not necessary for some patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include discomfort at surgical sites, bloating, difficulty swallowing, or other complications related to standard laparoscopic hernia repair procedures.
PEHFLIP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GERD
Secondary outcome measures
hernia recurrence
PEHFLIP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
No Fundoplication
Group II: Control GroupActive Control1 Intervention
Fundoplication
Find a Location
Who is running the clinical trial?
The Foundation for Surgical Innovation and EducationLead Sponsor
Christy M Dunst, MDPrincipal InvestigatorThe Oregon Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My esophagus was found to be shorter than normal during surgery.My tests show a faulty valve between my stomach and esophagus.I have had surgery to fix a hiatal or paraesophageal hernia.I have been diagnosed with GERD based on tests.I am having surgery to fix a hernia near my esophagus using small incisions.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Study Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings for individuals to join the trial?
"According to the information found on clinicaltrials.gov, recruitment for this trial has been suspended since March 29th 2023 - it was initially posted on February 22nd of that year. However, there are 156 studies actively seeking out new participants at present."
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