50 Participants Needed

Hiatal Hernia Repair for GERD Symptoms

CE
GT
GT
Overseen ByGreg T Scarola, MS, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.

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. It's best to discuss this with the trial coordinators or your doctor.

Is hiatal hernia repair for GERD symptoms generally safe for humans?

The research articles provided do not contain specific safety data for hiatal hernia repair or the related devices like EndoFLIP 1.0 System EF-100. They discuss general surgical safety and adverse events, but not specific to this treatment.12345

How does hiatal hernia repair for GERD symptoms differ from other treatments?

Hiatal hernia repair for GERD (gastroesophageal reflux disease) symptoms is unique because it involves a surgical procedure to fix the hernia, which may help reduce reflux symptoms. Unlike medications that manage symptoms, this treatment addresses the physical cause of GERD by repairing the hernia, potentially offering a more long-term solution.678910

What data supports the effectiveness of the treatment EndoFLIP 1.0 System EF-100 for GERD symptoms?

Antireflux surgery, which is often used to treat GERD, is generally effective, with a majority of patients experiencing relief from symptoms. However, between 10 and 20 percent of patients may need additional surgery due to recurring symptoms. This suggests that while surgical interventions can be effective, there is a possibility of needing further treatment.1112131415

Who Is on the Research Team?

PD

Paul D Colavita, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need elective hiatal hernia repair and fundoplication, without spastic esophageal disorders or severe esophageal dysmotility. It's not for those with surgery risks, emergent repairs, redo surgeries, connective tissue diseases like scleroderma or lupus, esophageal varices, or cases requiring Collis gastroplasty.

Inclusion Criteria

I am having surgery for hiatal hernia and stomach wrap.
My esophagus functions normally, without any disorders like jackhammer esophagus or achalasia.
I am choosing to have surgery that is not urgent.

Exclusion Criteria

I cannot undergo surgery or endoscopy due to health risks.
I have a connective tissue disease like scleroderma or lupus.
Presence of IEM on Manometry
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Evaluation

Standard preoperative evaluation including EGD, esophageal manometry, and UGI imaging

2-4 weeks
2 visits (in-person)

Surgery and Intraoperative Assessment

Patients undergo hiatal hernia repair and fundoplication with intraoperative impedance planimetry using EndoFLIP

1 day
1 visit (in-person)

Postoperative Follow-up

Postoperative care and symptom assessment using GERD-HRQL and Mayo Dysphagia Questionnaire at 2 and 6 weeks

6 weeks
2 visits (in-person)

Long-term Follow-up

Long-term follow-up at 6 months to assess QOL symptoms via GERD-HRQL and Mayo Dysphagia Questionnaire

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • EndoFLIP 1.0 System EF-100
  • Surgeon unblinded
Trial Overview The study measures how the area where the stomach meets the esophagus changes in flexibility after hiatal hernia surgery using a device called EndoFLIP. It also looks at any links between this flexibility and life quality related to acid reflux (GERD) and swallowing difficulty.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgeon unblindedExperimental Treatment2 Interventions
Group II: Surgeon blindedActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Atrium Health

Lead Sponsor

Trials
122
Recruited
34,900+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study of 116 patients who underwent surgery for hiatal hernia and gastro-oesophageal reflux, those without severe reflux complications had better clinical outcomes and lower rates of recurrent hernia and pathological reflux.
Persistent reflux symptoms were primarily due to gastro-oesophageal reflux that was not corrected by surgery, and even asymptomatic patients showed signs of reflux, indicating that effective surgical intervention is more challenging in patients with severe complications.
Gastro-oesophageal reflux after surgical treatment of hiatal hernia with and without severe reflux complications. A follow-up study.Gatzinsky, P., Sandberg, N., Sihlbom, H.[2004]
In a study of 429 patients with GERD symptoms, a structured approach by general surgeons in a rural setting led to a high completion rate of diagnostic studies (92.7%), facilitating better patient management.
Approximately 75% of patients were found suitable for antireflux surgery, and about two-thirds of these candidates proceeded with the surgery, demonstrating the effectiveness of local surgical intervention in managing GERD.
Impact of Participation of Surgeons in Diagnostic Studies of Gastroesophageal Reflux Disease on Completion of Workup and Utilization of Antireflux Surgery.Fanous, MY., Jaehne, AK., Lorenson, D., et al.[2021]
In a study of 3717 patients who underwent antireflux surgery in Denmark, the long-term reoperation rate was found to be 12.8% after 15 years, indicating that a significant number of patients may experience recurrent symptoms requiring further surgery.
Reoperations were associated with higher complication rates compared to primary surgeries, with 30-day and 90-day complication rates of 7.0% and 8.3% for reoperations, compared to 3.4% and 4.8% for the initial procedures.
Reoperation after antireflux surgery: a population-based cohort study.Ljungdalh, JS., Rubin, KH., Durup, J., et al.[2021]

Citations

Gastro-oesophageal reflux after surgical treatment of hiatal hernia with and without severe reflux complications. A follow-up study. [2004]
Impact of Participation of Surgeons in Diagnostic Studies of Gastroesophageal Reflux Disease on Completion of Workup and Utilization of Antireflux Surgery. [2021]
Reoperation after antireflux surgery: a population-based cohort study. [2021]
Gastroesophageal Reflux Disease. [2020]
Selection criteria among gastroenterologists and surgeons for laparoscopic antireflux surgery. [2015]
Surgical error: ethical issues of adverse events. [2019]
Incidence and Risk Factors for Mortality Following Bariatric Surgery: a Nationwide Registry Study. [2022]
A perspective from clinical and business ethics on adverse events in hospitalized patients. [2018]
Pediatric Surgeon Perceptions of Participation in External Patient Safety Programs: impact on Patient Safety. [2022]
Detection of adverse events in general surgery using the " Trigger Tool" methodology. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Impact of concurrent hiatal hernia repair during laparoscopic sleeve gastrectomy on patient-reported gastroesophageal reflux symptoms: a state-wide analysis. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Repair of post-bariatric surgery, recurrent, and de novo hiatal hernias improves bloating, abdominal pain, regurgitation, and food intolerance. [2021]
Impact of hiatal hernia repair technique on patient-reported gastroesophageal reflux symptoms following laparoscopic sleeve gastrectomy. [2022]
In the eye of the beholder: surgeon variation in intra-operative perceptions of hiatal hernia and reflux outcomes after sleeve gastrectomy. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair: an Unresolved Question. [2022]
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