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Hiatal Hernia Repair for GERD Symptoms

N/A
Recruiting
Led By Paul D Colavita, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) or esophageal dysmotility (any evidence of ineffective esophageal motility disorder with failed swallows in > 50% of swallows and DCI < 450, or fragmented peristalsis as defined by Chicago Classification) assessed by preoperative high-resolution manometry
Must not have
Patients with contraindication to surgery or endoscopy
Connective tissue diseases such as scleroderma or lupus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing whether surgery to repair a hiatal hernia and to strengthen the valve between the stomach and esophagus improves GERD symptoms and makes it easier to swallow.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical surgical risks such as infection or complications from endoscopy like bleeding. The EndoFLIP procedure itself might cause discomfort or injury to the esophagus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery for hiatal hernia and stomach wrap.
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My esophagus functions normally, without any disorders like jackhammer esophagus or achalasia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo surgery or endoscopy due to health risks.
Select...
I have a connective tissue disease like scleroderma or lupus.
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I have had a hiatal hernia repair redone.
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I need immediate surgery.
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My esophagus is too short for standard surgery.
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I have enlarged veins in my esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in distensibility index
Secondary study objectives
Post-op GERD symptoms
Post-op dysphagia symptoms

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgeon unblindedExperimental Treatment2 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 blindedActive Control1 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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,657 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,683 Total Patients Enrolled
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,804 Total Patients Enrolled

Media Library

Surgeon unblinded Clinical Trial Eligibility Overview. Trial Name: NCT04450628 — N/A
Hiatal Hernia Research Study Groups: Surgeon blinded, Surgeon unblinded
Hiatal Hernia Clinical Trial 2023: Surgeon unblinded Highlights & Side Effects. Trial Name: NCT04450628 — N/A
Surgeon unblinded 2023 Treatment Timeline for Medical Study. Trial Name: NCT04450628 — N/A
~8 spots leftby Jul 2025
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