N/A
Completed N=73
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Hiatal Hernia With Gastroesophageal Reflux Disease · Gastroesophageal Reflux Disease · GERD
Source: ClinicalTrials.gov NCT03735862 ↗
Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Subjects Who Required a Revision of the Index Surgery. — 0 Participants
Summary
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Required a Revision of the Index Surgery. |
— | — |
| SECONDARY Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) |
7.1 | <0.001 sig |
| SECONDARY Medication Use |
7; 65 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT03735862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.