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The investigators prospectively studied ninety nine GERD patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. General surgeons and gastroenterologists participated in the study. GERD questions were recorded before and at six and twelve months.
GERD unresponsive to medical therapies can be treated by laparoscopic Nissen fundoplication or endoluminal techniques. The investigators have extensive experience with Transoral Incisionless Fundoplication(TIF). TIF is not indicated in patients with a hiatal hernia larger than 2 cm. Performing a Hiatal Hernia Repair(HHR) in those cases will make a patient eligible for TIF. HHR followed immediately by the TIF procedure under the same anesthetic session is called a Hybrid-TIF (HTIF). The study examines the safety and efficacy of this approach.
Prospective data were collected from patients who underwent HTIF at two 300 bed community hospitals. Questionnaires were administered before the procedure, and mailed at 6 and 12 mos. They were the GERD-HRQL-health related quality of life, RSI-reflux symptom index, and GSRS-gastrointestinal symptom rating scale.
The study continues with the new Esophyx-Z device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indiana group | 50 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication |
| |
| Wisconsin group | 49 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophyx | Device | Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Control of GERD symptoms | GERD health related quality of life questionnaire | one year |
| Control of GERD symptoms | Reflux symptom index questionnaire | one year |
| Control of GERD symptoms | Gastrointestinal symptom rating scale | one year |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with GERD
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| Name | Affiliation | Role |
|---|---|---|
| Peter Mavrelis, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital | Merrillville | Indiana | 46410 | United States | ||
| Affinity Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22014853 | Result | Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011 Dec;202(6):740-6; discussion 746-7. doi: 10.1016/j.amjsurg.2011.06.035. Epub 2011 Oct 20. |
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presentation at national meeting
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Appleton |
| Wisconsin |
| 54915 |
| United States |
| D004066 | Digestive System Diseases |