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RecruitingNCT07197619Updated Sep 29, 2025

Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair

An observational study in Paraesophageal Hernia, sponsored by Corewell Health West. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Corewell Health West · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
42
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Paraesophageal Hernia

Keywords

  • Paraesophageal
  • Hernia
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 42 is below the median of 151 across 29 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Corewell Health West is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Corewell Health General Surgery Patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
42 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Primary Outcome

    Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.

    Time frame: Immediately following procedure

Secondary outcomes

  1. Competeness of hernia sac excision

    Determining whether the hernia sac excision was complteted or partial

    Time frame: Immediately following procedure

  2. Paraesophageal hernia type

    Comparing the paraesophageal hernia type

    Time frame: Immediately following procedure

  3. Mesh useage

    Comparing the type of mesh used during the procedure

    Time frame: Immediately following procedure

  4. Complications

    Following patients for post-op complications

    Time frame: 30-days post-op

  5. Comparing dephographics

    Looking at the patients demographics and comparing them to the above outcomes

    Time frame: 30-days post-op

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2021 (actual). Primary completion is estimated for Mar 2026, 55 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2025
First posted
Sep 29, 2025
StartActual
Aug 27, 2021
Primary completionEst.
Mar 2026
CompletionEst.
Jun 2026
Last update
Sep 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07197619
Lead sponsor
Corewell Health West
Responsible party
Amy Banks-Venegoni (Principle Investigator, Corewell Health West) — Principal investigator
First posted
Sep 29, 2025
Start date
Aug 27, 2021
Primary completion
Mar 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Sep 29, 2025

Study contacts

kendra Selby
Contact
kendra.selby@helendevoschildrens.org
616-486-0281
Rachel Gross, BSN
Contact
rachel.gross@corewellhealth.org
616-391-3825

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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