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
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