Paraesophageal HerniaNCT07197619
Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair
An observational study of Paraesophageal Hernia, run by Corewell Health West at 1 site in United States.
Trial summary
Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paraesophageal Hernia
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to Jun 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Corewell Health General Surgery Patients
Who may be able to join
- All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.
Who cannot join
- Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Rachel Gross, 616-391-3825, rachel.gross@corewellhealth.org
Julia Reish, 616-426-2022, julia.reish@corewelhealth.org
About this study
Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Repair of a paraesophageal hernia is associated with significant recurrence rate, with primary repair often in excess of 50%. Hernia recurrence and revisional surgery significantly increase the likelihood of complications and decreased quality of life.
- Conditions
- Paraesophageal Hernia
- Keywords
- Paraesophageal, Hernia
- Medical subject headings
- Hernia, Hiatal, Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.
Measured: Immediately following procedure
Secondary outcomes (5)
Competeness of hernia sac excision
Determining whether the hernia sac excision was complteted or partial
Measured: Immediately following procedure
Paraesophageal hernia type
Comparing the paraesophageal hernia type
Measured: Immediately following procedure
Mesh useage
Comparing the type of mesh used during the procedure
Measured: Immediately following procedure
Complications
Following patients for post-op complications
Measured: 30-days post-op
Comparing dephographics
Looking at the patients demographics and comparing them to the above outcomes
Measured: 30-days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start27 Aug 2021
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraesophageal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Banks-Venegoni, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197619
- Sponsor's protocol ID
- 2019-732
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair
- ClinicalTrials.gov ID
- NCT07197619
- Acronym / sponsor ID
- 2019-732
- Conditions
- Paraesophageal Hernia
- Keywords
- Paraesophageal, Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Repair of a paraesophageal hernia is associated with significant recurrence rate, with primary repair often in excess of 50%. Hernia recurrence and revisional surgery significantly increase the likelihood of complications and decreased quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Corewell Health General Surgery Patients
Key inclusion criteria (1 listed)
- All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.
Key exclusion criteria (1 listed)
- Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome
Time frame: Immediately following procedure
Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.
5 secondary outcomes
Competeness of hernia sac excision
Time frame: Immediately following procedure
Paraesophageal hernia type
Time frame: Immediately following procedure
Mesh useage
Time frame: Immediately following procedure
Complications
Time frame: 30-days post-op
Comparing dephographics
Time frame: 30-days post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Related trials for Paraesophageal Hernia
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Mesh Vs Pledgets for Repair of Paraesophageal Hernia
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Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
Hiatal Hernia
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Antireflux Surgery Without Preoperative Esophageal Manometry
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Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraesophageal Hernia, run by Corewell Health West 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kendra Selby (616-486-0281, kendra.selby@helendevoschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Immediately following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.