Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Paraesophageal Hernia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Primary Outcome [Time frame: Immediately following procedure]
Secondary outcome measures (5)
- Competeness of hernia sac excision [Time frame: Immediately following procedure]
- Paraesophageal hernia type [Time frame: Immediately following procedure]
- Mesh useage [Time frame: Immediately following procedure]
- Complications [Time frame: 30-days post-op]
- Comparing dephographics [Time frame: 30-days post-op]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Corewell Health — Grand Rapids
Identifiers
NCT: NCT07197619 · 2019-732