Laparoscopic Hernia Repair for Hiatal Hernia

(PEHFLIP Trial)

Recruiting 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

260 Participants Needed

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{3 5 11 12 13}

Research Team

Christy M Dunst, MD

Principal Investigator

The Oregon Clinic

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.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Laparoscopic repair of a paraesophageal hiatus hernia without fundoplication. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Repair of paraesophageal hernias. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic repair of paraesophageal hiatal hernias. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic repair of paraesophageal hernia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Paraesophageal Hiatal Hernia Repair With Urinary Bladder Matrix Graft. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Complications of diagnostic upper Gastrointestinal endoscopy: common and rare - recognition, assessment and management. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Medical Adverse Events/Near Misses Associated With Laparoscopic/Thoracoscopic Surgery: A Retrospective Study Based on the Japanese National Database of Medical Adverse Events. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Therapeutic Endoscopic Retrograde Pancreatography. [2023]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

The nature, patterns, clinical outcomes, and financial impact of intraoperative adverse events in emergency surgery. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic technique for repair of paraesophageal hiatal hernias. [2019]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

A case of paraesophageal hernia repaired by laparoscopic approach. [2015]

13. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic repair of large hiatal hernia with teres ligament: midterm follow-up: a new surgical procedure. [2021]