Laparoscopic Hernia Repair for Hiatal Hernia
(PEHFLIP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChristy M Dunst, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

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.

Inclusion Criteria

I am having surgery to fix a hernia near my esophagus using small incisions.

Exclusion 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.

+2 more

Participant Groups

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