Laparoscopic Hernia Repair for Hiatal Hernia
(PEHFLIP Trial)
What You Need to Know Before You Apply
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is laparoscopic hernia repair for hiatal hernia generally safe for humans?
Research on laparoscopic and thoracoscopic surgeries, which are similar to laparoscopic hernia repair, shows that while adverse events (unwanted side effects) can occur, understanding and managing these events can help improve safety. This suggests that with proper precautions, laparoscopic hernia repair is generally safe.12345
How does laparoscopic paraesophageal hernia repair without fundoplication differ from other treatments for hiatal hernia?
Laparoscopic paraesophageal hernia repair without fundoplication is unique because it avoids the traditional wrapping of the stomach around the esophagus (fundoplication), focusing instead on closing the hernia with mesh and attaching the stomach to the diaphragm. This minimally invasive approach results in less discomfort and faster recovery compared to open surgery.678910
What data supports the effectiveness of the treatment Laparoscopic paraesophageal hernia repair without fundoplication?
Research shows that laparoscopic repair of paraesophageal hernias is safe and effective, with patients experiencing relief from symptoms, less pain after surgery, and a quick return to normal activities. In one case, the patient had no reflux or complications for 12 months after the procedure, indicating its potential effectiveness.910111213
Who Is on the Research Team?
Christy M Dunst, MD
Principal Investigator
The Oregon Clinic
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic paraesophageal hernia repair with or without fundoplication based on randomization
Follow-up
Participants are monitored for GERD and hernia recurrence through endoscopic evaluation and pH testing
What Are the Treatments Tested in This Trial?
Interventions
- Laparoscopic paraesophageal hernia repair without fundoplication
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Foundation for Surgical Innovation and Education
Lead Sponsor