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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

No Placebo-Only Group

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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met