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| Name | Class |
|---|---|
| EndoGastric Solutions | INDUSTRY |
| University of California, Irvine | OTHER |
| Fox Valley Surgical Associates | UNKNOWN |
| University of Southern California |
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This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Nissen Fundoplication (LNF) | Active Comparator | Control |
|
| Combo Transoral Incisionless Fundoplication (CTIF) | Active Comparator | Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION | Procedure | LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference in HRQL score ≤ 15% | Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score. GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15.
Heartburn Score: Calculated by summing the individual scores to questions 1-6 .
Regurgitation Score: Calculated by summing the individual scores to questions 10-15.
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AET | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] |
| Incidence of bloating | Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form |
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Inclusion Criteria:
22-80 years of age
Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
Pathologic reflux while off PPI based on Lyon criteria by either of the following:
3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
Commitment to long-term study
Ability to give consent individually or by a legally authorized representative
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| University of Southern California |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Health information may be collected from: Past, present and future medical records. Research procedures, including research office visits, tests, interviews and questionnaires. Health information will be used and/or given to others to: Do the research. Report the results. See if the research was conducted following the approved study plan, and applicable rules and regulations. Health information may be used and shared with: Mayo Clinic research staff involved in this study or clinical care. Researchers involved in this study at other institutions. The sponsor of this study and the people or groups hired by the sponsor to help perform this research. The Mayo Clinic Institutional Review Board that oversees the research. Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.
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| OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| University of Texas at Austin | OTHER |
| Institute of Esophageal and Reflux Surgery | UNKNOWN |
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Measures will be taken to minimize or avoid bias in the study "masking/blinding procedures." Neither treatment groups will be advised as to which procedure (TIF or LNF) they will be receiving. Randomization assignment will be recorded in the EDC and subject tracking, but will not be recorded within the EMR to reduce clinical team exposure to their randomized status for follow-up care. Research teams will not be blinded to the randomization results.
|
| [Time Frame: 6 months] |
| Incidence of dysphagia | Dysphagia, Bloating, & Reflux Symptoms Questionnaire (DBR) Case Report Form | [Time Frame: 6 months] |
| Change in distensibility index of GE junction | Endoflip (optional) Case Report Form | [Time Frame: 6 months] |
| Cessation of Proton Pump Inhibitor (PPI) use | PPI Use Questionnaire Case Report Form | [Time Frame: 6 months] |
| Healing of esophagitis | Upper Endoscopy with 72 Hrs BravoPH Case Report Form assessing LA Grade system: A, B, C, or D (if present) Grade A One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal folds Grade B One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal folds Grade C One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which involve less than 75% of the circumference Grade D One (or more) mucosal break which involves at least 75% of the esophageal circumference | [Time Frame: 6 months] |
| Recurrence of hiatal hernia | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] |
| Hill grade of GE junction | Upper Endoscopy with 72 Hrs BravoPH Case Report Form | [Time Frame: 6 months] |
| Adverse events rate | Adverse Event Case Report Form | [Time Frame: 6 months] |
| Los Angeles |
| California |
| 90033 |
| United States |
| Institute of Esophageal and Reflux Surgery | Englewood | Colorado | 880113 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Fox Valley Surgical | Appleton | Wisconsin | 54911 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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