Hiatal Hernia Repair for GERD Symptoms

Overseen By Greg T Scarola, MS, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Redo repairs, Emergent repairs, Varices, Connective tissue diseases, others

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

Compensation: Varies

Number of Visits: 7

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether repairing a hiatal hernia and performing a fundoplication (a surgery that wraps the top of the stomach around the lower esophagus) can alter the function of the esophagogastric junction and affect GERD symptoms. It compares two groups: one where surgeons know certain measurements during surgery and can adjust the procedure, and another where they do not. Individuals with a hiatal hernia scheduled for elective surgery may qualify for this trial, provided they do not have certain esophageal disorders. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

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.

What prior data suggests that the EndoFLIP 1.0 System EF-100 is safe for use in hiatal hernia repair?

The EndoFLIP system, used in this trial for hiatal hernia repair, is generally considered safe. Research has shown that this technology measures pressure and size in the esophagus and nearby areas during surgery. It provides real-time feedback to surgeons, potentially improving surgical outcomes without adding extra risk.

Specific data on negative effects from using EndoFLIP alone is limited. However, its use in similar situations has not raised major safety concerns. As this study is not in its early stages, there is increased confidence in the treatment's safety. Notably, the EndoFLIP device is already used in other medical procedures, indicating it is well-tolerated.

When considering participation in a trial like this, discussing any personal health concerns or questions with healthcare providers is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how real-time data can enhance surgical outcomes for GERD patients with hiatal hernias. Traditional treatments like medications or fundoplication surgery don't typically involve immediate feedback during the procedure. This trial uses EndoFLIP technology to provide surgeons with detailed measurements of the esophagogastric junction during surgery, allowing them to adjust the procedure on the spot. By comparing surgeries where the surgeon is informed of these measurements to those where they are not, researchers aim to see if this tailored approach improves patient outcomes and reduces GERD symptoms.

What evidence suggests that the EndoFLIP 1.0 System EF-100 is effective for GERD symptoms?

This trial will compare two approaches to hiatal hernia surgery for GERD symptoms. In one arm, the surgeon will not have access to EndoFLIP measurements, while in the other arm, the surgeon will use EndoFLIP feedback to adjust the surgical procedure. Research has shown that the EndoFLIP system, which measures pressure and size in the esophagus, provides real-time feedback during hiatal hernia surgery. This feedback helps surgeons make better decisions, potentially improving outcomes for patients with GERD (gastroesophageal reflux disease). Studies have found that using EndoFLIP during surgery can lead to better symptom control by enhancing the repair where the esophagus meets the stomach. While more data is needed, early findings suggest this method could improve quality of life and reduce symptoms like heartburn and difficulty swallowing. ^{1 2 3 4 6}

Who Is on the Research Team?

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

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?

Group I: Surgeon unblinded Experimental Treatment 2 Interventions

The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups. Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.

Group II: Surgeon blinded Active Control 1 Intervention

During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.

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

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study of 28,755 patients who underwent bariatric surgery in Israel, the overall 3.5-year post-surgery mortality rate was low at 0.04%, indicating that bariatric surgery is generally safe.

Risk factors for increased mortality included male gender, older age, higher BMI, and preoperative depression, suggesting that these patients may need closer monitoring and support after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Mortality Following Bariatric Surgery: a Nationwide Registry Study. Sakran, N., Sherf-Dagan, S., Blumenfeld, O., et al.[2022]

Repairing hiatal hernias in 52 patients who had undergone bariatric surgery significantly improved symptoms related to bloating, abdominal pain, and dysphagia, with over 80% of patients experiencing relief from dysphagia or regurgitation after an average follow-up of 12 months.

The study found that hiatal hernias were diagnosed using imaging and endoscopy, and that these hernias occurred more frequently after sleeve gastrectomy compared to Roux-en-Y gastric bypass, indicating a need for careful monitoring in post-bariatric surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of post-bariatric surgery, recurrent, and de novo hiatal hernias improves bloating, abdominal pain, regurgitation, and food intolerance. Golas, A., El-Attrache, BM., Jorge, J., et al.[2021]

In a study of 7,883 patients undergoing laparoscopic sleeve gastrectomy (SG) with hiatal hernia repair, the most common technique used was posterior repair (PR), which was associated with better outcomes for gastroesophageal reflux disease (GERD) symptoms compared to anterior repair (AR).

Patients whose surgeons performed AR were more likely to experience worsening GERD symptoms one year after surgery, despite similar weight loss across all repair techniques, suggesting that the choice of surgical technique may significantly impact post-operative GERD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of hiatal hernia repair technique on patient-reported gastroesophageal reflux symptoms following laparoscopic sleeve gastrectomy. Ehlers, AP., Bonham, AJ., Ghaferi, AA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Patients who underwent laparoscopic sleeve gastrectomy (LSG) with concurrent posterior hiatal hernia repair (HHR) reported greater improvement in gastroesophageal reflux disease (GERD) symptoms after one year compared to those who had LSG alone, with a symptom improvement rate of 69.5%.

In contrast, patients who had anterior HHR did not experience significant benefits in symptom improvement and faced higher rates of complications such as hemorrhage and readmissions, suggesting that anterior HHR should be avoided during LSG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of concurrent hiatal hernia repair during laparoscopic sleeve gastrectomy on patient-reported gastroesophageal reflux symptoms: a state-wide analysis. Hider, AM., Bonham, AJ., Carlin, AM., et al.[2023]

In a study of 165 patients who underwent laparoscopic sleeve gastrectomy (LSG), the addition of hiatal hernia repair (HHR) did not significantly improve gastroesophageal reflux disease (GERD) symptoms post-surgery, with similar rates of symptom remission in both groups after 1 and 2 years.

Despite a higher prevalence of baseline GERD symptoms in patients who had HHR, the rates of new-onset GERD were also comparable between those who had HHR and those who did not, suggesting that routine HHR during LSG may not be beneficial for GERD outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair: an Unresolved Question. Dakour Aridi, H., Asali, M., Fouani, T., et al.[2022]

A survey of 353 pediatric surgeons revealed that while 72% are aware of their institutions' participation in external safety benchmark programs, only 68% actively use the data to enhance patient safety.

Barriers to utilizing safety data include a lack of knowledge, insufficient time, and limited institutional resources, highlighting areas for improvement in educational efforts to enhance pediatric surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Surgeon Perceptions of Participation in External Patient Safety Programs: impact on Patient Safety. Berman, L., Rangel, S., Tsao, K.[2022]

The study found a high prevalence of adverse events (AEs) in surgical patients, with 36.8% of patients experiencing at least one AE, and 56.2% of these events deemed preventable.

The adapted 'Global Trigger Tool' methodology proved to be highly effective in detecting AEs, with a sensitivity of 86% and specificity of 93.6%, indicating it is a reliable tool for improving patient safety in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of adverse events in general surgery using the " Trigger Tool" methodology. Pérez Zapata, AI., Gutiérrez Samaniego, M., Rodríguez Cuéllar, E., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Modern medical treatments for GERD, particularly proton pump inhibitors, are highly effective, making it rare for patients to have symptoms that do not respond to these therapies, which suggests that many patients labeled as 'medical failures' may actually have misdiagnosed conditions.

Antireflux surgery is a suitable option for patients who have documented GERD and respond well to medical therapy, as it can help those who prefer to avoid long-term medication, but it is not recommended for patients whose symptoms are not caused by acid reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroesophageal Reflux Disease. Spechler, SJ.[2020]

A survey of 1,000 gastroenterologists and 1,000 laparoscopic surgeons revealed differing opinions on the ideal candidates for laparoscopic antireflux surgery, with gastroenterologists being more hesitant to refer patients for surgery.

Gastroenterologists typically view patients with uncontrolled symptoms or complications as suitable for surgery, while surgeons also consider those whose symptoms are well-managed with medication, highlighting the need for a consensus on surgical criteria for GERD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection criteria among gastroenterologists and surgeons for laparoscopic antireflux surgery. Sarani, B., Scanlon, J., Jackson, P., et al.[2015]

Adverse events in surgery are common and can significantly delay recovery and harm patients, highlighting the ethical responsibility to minimize these risks.

Five key issues hinder improvements in surgical quality: lack of data on adverse event incidence, insufficient practice guidelines, a culture of blame, challenges in compensating injured patients, and difficulties in honest communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical error: ethical issues of adverse events. Krizek, TJ.[2019]

In a study involving 38 surgeons reviewing 33 videos of laparoscopic sleeve gastrectomy (LSG), only 26% identified hiatal hernias, indicating variability in diagnosis among surgeons.

Surgeons who identified hiatal hernias tended to perform more concurrent repairs, but this did not lead to improved outcomes, as patients still reported higher rates of new reflux symptoms and lower rates of antacid discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the eye of the beholder: surgeon variation in intra-operative perceptions of hiatal hernia and reflux outcomes after sleeve gastrectomy. Ehlers, AP., Chhabra, K., Thumma, JR., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reoperation after antireflux surgery: a population-based cohort study. Ljungdalh, JS., Rubin, KH., Durup, J., et al.[2021]

Adverse events in hospitalized patients are often due to systemic issues rather than individual mistakes, highlighting the need for improved reporting and system changes.

Addressing and reducing these adverse events is not only ethically responsible but also cost-effective for hospitals, making it a crucial focus for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective from clinical and business ethics on adverse events in hospitalized patients. Wagner, JT., Meier, C., Higdon, T.[2018]

Citations

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Functional Lumen Imaging Probe for the Management of ... EndoFLIP System, EF-100, For use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters.

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Devices for esophageal function testing FLIP is a high-resolution impedance planimetry system used for pressure and dimension measurement in the esophagus, pylorus, and anal sphincter. FLIP provides ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32661713/

Short-term outcome of routine use of EndoFLIP during ... EndoFLIP technology is a tool that can be used to provide intraoperative objective real-time feedback during hiatal hernia repair.

4. cghjournal.org cghjournal.org/article/S1542-3565(16)30987-9/pdf

EXPERT REVIEW - Functional Lumen Imaging Probe for ... This clinical practice update on FLIP reviews the methodology of the technique and the data supporting its clinical utility in specific ...

5. revistagastrocol.com revistagastrocol.com/index.php/rcg/article/download/741/1263/8199

EndoFLIP: a new technology The endoluminal functional luminal-imaging probe. (EndofLIP) measures intra-balloon pressure, cross- sectional areas of the esophagus, and esophagogastric.

6. scielo.org.co scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-99572021000200227

EndoFLIP: a new technology EndoFLIP evaluates biomechanical properties such as distensibility, volume, pressure, and even diameters of sphincter regions like the gastroesophageal ...