Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-26

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paraesophageal Hernia Hiatal Hernia Large

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Intervention 1 (Control)

No anterior gastropexy will be performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention 2 (Treatment)

Anterior gastropexy will be performed.

Group Type EXPERIMENTAL

Anterior Gastropexy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No