Laparoscopic Hernia Repair for Hiatal Hernia

(PEHFLIP Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Foundation for Surgical Innovation and Education

Disqualifiers: Prior hernia repair, GERD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether some patients can skip fundoplication during laparoscopic paraesophageal hernia repair. Fundoplication is often added to prevent acid reflux, but it might not be necessary for everyone. The trial targets individuals undergoing this hernia surgery for the first time who do not have severe reflux issues. Participants will help determine who truly needs the extra step. As an unphased trial, it offers participants the chance to contribute to personalized surgical approaches and potentially avoid unnecessary procedures.

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.

What prior data suggests that laparoscopic paraesophageal hernia repair without fundoplication is safe?

Research has shown that laparoscopic paraesophageal hernia repair without fundoplication is generally safe for patients. One study found that about 25% of patients experienced early swallowing difficulties, but these issues resolved over time. Another report indicated that over 91% of patients had very good early results, with no increased risk of complications or hospital readmission within 30 days. These findings suggest that the procedure is well-tolerated and not associated with significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for hiatal hernia, which often includes fundoplication, the laparoscopic paraesophageal hernia repair being studied skips this step. Fundoplication involves wrapping the top of the stomach around the lower esophagus to prevent acid reflux, but it can lead to complications like difficulty swallowing. This new approach aims to repair the hernia without altering stomach anatomy, potentially reducing post-surgery issues while still effectively addressing the hernia. Researchers are excited because it could offer a less invasive option with fewer side effects, improving patient comfort and recovery time.

What evidence suggests that laparoscopic paraesophageal hernia repair without fundoplication is effective for hiatal hernia?

This trial will compare two approaches to laparoscopic paraesophageal hernia repair: one with fundoplication and one without. Research has shown that repairing a paraesophageal hernia using minimally invasive surgery, without adding fundoplication, can be effective. One study found that this surgery leads to excellent results and a short hospital stay when performed at experienced centers. Another study suggested that skipping fundoplication does not increase the risk of issues like acid reflux, which fundoplication is meant to prevent. However, there is a higher chance of the hernia returning, with up to 23% of patients needing another surgery. Despite this, the recurrence doesn't seem to affect long-term function for most patients. Overall, this approach might be a good option for some, but it's important to consider the possibility of needing another procedure. ^{3 6 7 8 9}

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic paraesophageal hernia repair with or without fundoplication based on randomization

1 week

1 visit (in-person)

Follow-up

Participants are monitored for GERD and hernia recurrence through endoscopic evaluation and pH testing

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Laparoscopic paraesophageal hernia repair without fundoplication

Trial Overview

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.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 Intervention

No Fundoplication

Group II: Control Group Active Control 1 Intervention

Fundoplication

Who Is Running the Clinical Trial?

The Foundation for Surgical Innovation and Education

Lead Sponsor

Trials

1

Recruited

260+

Published Research Related to This Trial

The overall rate of perioperative adverse events (AEs) in thoracic surgery was low at 0.2%, with the majority of AEs caused by surgical factors (55.3%) and anaesthesia-related factors (23.3%), indicating that while AEs are infrequent, they are often linked to critical aspects of the surgical process.

Sudden cardiac arrest and massive hemorrhage were the two major clinical manifestations of AEs, with timely identification and treatment being crucial for improving patient outcomes, as 8% of patients with AEs died within 3 days, primarily due to massive hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of 62,571 cases of perioperative adverse events in thoracic surgery at a tertiary care teaching hospital in a developing country. Li, Q., Zhang, X., Xu, M., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4208886/

Laparoscopic Repair of Paraesophageal Hernias - PMC

Conclusion: Laparoscopic paraesophageal hernia repair results in an excellent outcome with a short length of stay when performed at an experienced center.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1091255X23037083

Laparoscopic Paraesophageal Hernia Repair

At 6 months, the recurrence rate was 9% for the group that received a biologic mesh and 24% for the group that underwent primary repair only.6 More recently, we ...

3.

link.springer.com

link.springer.com/article/10.1007/s00423-024-03340-w

Functional results after hiatal repair and gastropexy without ...

Although the rate of PEH recurrence requiring a new re-intervention remained increased (23%), it does not seem to affect long-term functional ...

4.

academic.oup.com

academic.oup.com/dote/article/38/3/doaf036/8134376

No advantage of fundoplication in paraesophageal hernia repair

The findings in this study suggest that a fundoplication is unnecessary in paraesophageal hernia repair. It did not protect against either ...

5.

vats.amegroups.org

vats.amegroups.org/article/view/7270/html

Laparoscopic paraesophageal hernia repair with absorbable ...

The use of absorbable mesh seems safe and effective with low overall and mesh-related complications, acceptable recurrence rate and low need for re-do surgery.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4754198/

Laparoscopic Hiatal Hernia Repair in 221 Patients

Although 25% of our patients reported early dysphagia after LHHR, in all cases it resolved over time. We believe that we see a moderate amount of dysphagia ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1091255X23085955

Laparoscopic Repair of Large Hiatal Hernia Without ...

Eleven patients (12.3%) were lost to follow-up. We had 91.5% of very good early functional results and 75.3% of good results after a mean follow-up of 57.5 ...

8.

link.springer.com

link.springer.com/article/10.1007/s00464-025-11924-w

Restoration of normal anatomy without fundoplication in ...

We have demonstrated in our study that giant paraesophageal hernia repair with restoration of normal anatomy can be safely performed in non- ...

9.

nature.com

nature.com/articles/s41598-020-61566-2

Short-Term Outcomes in Patients Undergoing ...

While overall our findings indicate no increased risk of 30-day readmission or complications associated with minimally-invasive HH repair, ...