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Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

C

Clayton Petro

Status

Completed

Conditions

Hiatal Hernia Large
Paraesophageal Hernia

Treatments

Procedure: Anterior Gastropexy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups

Intervention 1 (Control)
No Intervention group
Description:
No anterior gastropexy will be performed.
Intervention 2 (Treatment)
Experimental group
Description:
Anterior gastropexy will be performed.
Treatment:
Procedure: Anterior Gastropexy

Trial contacts and locations

1

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Central trial contact

Samuel J Zolin, MD; Clayton C Petro, MD

Data sourced from clinicaltrials.gov

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