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

Recruiting

• Conditions: Paraesophageal Hernia

• Registration Number: NCT07197619
• Lead Sponsor: Spectrum Health Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-27
• Study First Submitted: 2025-02-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2026-03
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	Immediately following procedure	Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.

Secondary Outcome Measures

Name	Time	Method
Competeness of hernia sac excision	Immediately following procedure	Determining whether the hernia sac excision was complteted or partial
Paraesophageal hernia type	Immediately following procedure	Comparing the paraesophageal hernia type
Mesh useage	Immediately following procedure	Comparing the type of mesh used during the procedure
Complications	30-days post-op	Following patients for post-op complications
Comparing dephographics	30-days post-op	Looking at the patients demographics and comparing them to the above outcomes

Trial Locations

Locations (1)

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States