Paraesophageal Hernia Clinical Trial
Official title:
Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair
NCT number | NCT04007952 |
Other study ID # | 19-616 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 26, 2019 |
Est. completion date | February 28, 2024 |
Verified date | March 2024 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Clayton Petro |
United States,
Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29. Erratum In: J Am Coll Surg. 2011 Dec;213(6):815. — View Citation
Ponsky J, Rosen M, Fanning A, Malm J. Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003 Jul;17(7):1036-41. doi: 10.1007/s00464-002-8765-2. Epub 2003 Mar 28. — View Citation
Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Paraesophageal Hernia Recurrence | Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence | 1 year | |
Secondary | 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. | 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) | |
Secondary | 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. | 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) |
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