An interventional study of Anterior Gastropexy in Paraesophageal Hernia and Hiatal Hernia Large, sponsored by Clayton Petro. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Clayton Petro · Not applicable, Interventional, and Treatment
This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.
Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.
These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's enrollment of 240 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
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Exclusion Criteria:
No anterior gastropexy will be performed.
Anterior gastropexy will be performed.
Procedure: Anterior Gastropexy
Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.
Paraesophageal Hernia Recurrence
Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence
Time frame: 1 year
Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year
The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease. Scores on individual items are summed and may range from 0 to 50, with higher scores indicating greater severity of symptoms and worse quality of life. Additionally, there is a question about global satisfaction with quality of life, which may be answered as "satisfied," "neutral," or "dissatisfied." The percentages of these categories will be reported.
Time frame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)
Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year
Eight symptoms that are potentially related to the presence of a paraesophageal hernia will be assessed on a scale ranging from 0 to 10, with higher scores indicating more significant impact on quality of life. Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. Each symptom will be reported separately.
Time frame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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