Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    240
  • sponsor
    The Cleveland Clinic
Updated on 25 March 2022

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.

Details
Condition Paraesophageal Hernia, Hiatal Hernia Large
Treatment Anterior Gastropexy
Clinical Study IdentifierNCT04007952
SponsorThe Cleveland Clinic
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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