Recruiting

Observational Study

Sponsor:

Spectrum Health Hospitals

Code:

NCT07197619

Conditions

Paraesophageal Hernia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Paraesophageal Hernia

Study ID

NCT07197619

Start date

Aug 27, 2021

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Outcome [ Time Frame: Immediately following procedure ]

Central Contacts and Locations

Locations

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Amy Banks-Venegoni, MD

More Information

Sponsor

Spectrum Health Hospitals

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Paraesophageal
  • Hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spectrum Health Hospitals on 2025-09-29.