Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007952
• Other study ID #: 19-616
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia Large
• Paraesophageal Hernia

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Clayton Petro

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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)

External Links

•   SAGES Guidelines for Management of Hiatal Hernia