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Paraesophageal HerniaNCT04007952

Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

A study testing Anterior Gastropexy in people with Paraesophageal Hernia and Hiatal Hernia Large, run by Clayton Petro at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paraesophageal Hernia, Hiatal Hernia Large
What is being tested?
Anterior Gastropexy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
26 Jun 2019to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18+
  • Able to participate in follow-up
  • Symptomatic paraesophageal hernia
  • Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
  • Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
  • Crura must be reapproximated at time of surgery

Who cannot join

  • Previous operations of the esophagus or stomach
  • Emergent operation for acute gastric volvulus
  • Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
  • Placement of gastrostomy tube

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair

This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

Read the detailed description

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

Being tested
Anterior Gastropexy
Keywords
paraesophageal hernia, gastropexy, minimally invasive surgery
Medical subject headings
Hernia, Hiatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anterior GastropexyProcedure or surgery

    Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.

Study groups in NCT04007952
Study groupRoleWhat they receive
Intervention 1 (Control)No interventionNo anterior gastropexy will be performed.
Intervention 2 (Treatment)ExperimentalAnterior gastropexy will be performed.
Receives: Procedure: Anterior Gastropexy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paraesophageal Hernia Recurrence

    Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence

    Measured: 1 year

Secondary outcomes (2)

  1. Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year

    The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease. Scores on individual items are summed and may range from 0 to 50, with higher scores indicating greater severity of symptoms and worse quality of life. Additionally, there is a question about global satisfaction with quality of life, which may be answered as "satisfied," "neutral," or "dissatisfied." The percentages of these categories will be reported.

    Measured: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)

  2. Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year

    Eight symptoms that are potentially related to the presence of a paraesophageal hernia will be assessed on a scale ranging from 0 to 10, with higher scores indicating more significant impact on quality of life. Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. Each symptom will be reported separately.

    Measured: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start26 Jun 2019
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a double-blinded, registry-based, randomized control trial comparing anterior gastropexy to no anterior gastropexy in paraesophageal hernia repair. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04007952
Sponsor's protocol ID
19-616
Status last verified
Mar 2024
First submitted
2 Jul 2019
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ponsky J, Rosen M, Fanning A, Malm J. Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003 Jul;17(7):1036-41. doi: 10.1007/s00464-002-8765-2. Epub 2003 Mar 28.

    PubMed 12658421

  • Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29.

    PubMed 21715189

  • Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x.

    PubMed 17439596

  • Bennett WC, Ellis RC, Mohamed MO, Conner AS, Tu C, Miller BT, Beffa LR, Krpata DM, Rosen MJ, Prabhu AS, Petro CC. Defining Clinically Significant Radiographic Recurrence after Paraesophageal Hernia Repair: Post Hoc Analysis of Patient-Reported Outcomes and Reoperation from a Randomized Controlled Trial. J Am Coll Surg. 2026 Sep 1;243(3):551-562. doi: 10.1097/XCS.0000000000001927. Epub 2026 Aug 14.

    PubMed 41848187

  • Petro CC, Ellis RC, Maskal SM, Zolin SJ, Tu C, Costanzo A, Beffa LRA, Krpata DM, Alaedeen D, Prabhu AS, Miller BT, Baier KF, Fathalizadeh A, Rodriguez J, Rosen MJ. Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2025 Mar 1;160(3):247-255. doi: 10.1001/jamasurg.2024.5788.

    PubMed 39714889

  • Blake KE, Zolin SJ, Tu C, Baier KF, Beffa LR, Alaedeen D, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial. Trials. 2022 Jul 30;23(1):616. doi: 10.1186/s13063-022-06571-8.

    PubMed 35907909

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Gastropexy in people with Paraesophageal Hernia and Hiatal Hernia Large, run by Clayton Petro at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paraesophageal Hernia Recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04007952, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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