Hiatal Hernia Large, Paraesophageal Hernia
Conditions
Keywords
paraesophageal hernia, gastropexy, minimally invasive surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAnterior 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.
Sponsors
Clayton Petro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will not be informed regarding the treatment that they received until they complete 1-year follow-up. Imaging will be reviewed at the end of the study period by surgeons who are blinded to treatment group.
Intervention model description
This will be a double-blinded, registry-based, randomized control trial comparing anterior gastropexy to no anterior gastropexy in paraesophageal hernia repair. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ * Able to participate in follow-up * Symptomatic paraesophageal hernia * Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy * Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed) * Crura must be reapproximated at time of surgery
Exclusion criteria
* Previous operations of the esophagus or stomach * Emergent operation for acute gastric volvulus * Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume * Placement of gastrostomy tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paraesophageal Hernia Recurrence | 1 year | Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year | 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) | 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. |
| Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year | 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) | 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. |
Countries
United States
Outcome results
None listed