NCT07197619

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2021Jun 2026

Study Start

First participant enrolled

August 27, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

February 26, 2025

Last Update Submit

September 22, 2025

Conditions

Paraesophageal Hernia

Keywords

ParaesophagealHernia

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

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

    Immediately following procedure

Secondary Outcomes (5)

  • Competeness of hernia sac excision

    Immediately following procedure

  • Paraesophageal hernia type

    Immediately following procedure

  • Mesh useage

    Immediately following procedure

  • Complications

    30-days post-op

  • Comparing dephographics

    30-days post-op

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Corewell Health General Surgery Patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Hernia, HiatalHernia

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

kendra Selby

CONTACT

616-486-0281kendra.selby@helendevoschildrens.org

Rachel Gross, BSN

CONTACT

616-391-3825rachel.gross@corewellhealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 26, 2025

First Posted

September 29, 2025

Study Start

August 27, 2021

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

US(1)